Ex parte Chang

Board of Patent Appeals and Interferences

Sep 30, 1999

08046364 (B.P.A.I. Sep. 30, 1999)

Application for patent filed April 8, 1993. According to appellant, this application is a continuation1
of 07/819,449, filed January 10, 1992, now abandoned.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for
publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 31
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte
TSE W. CHANG
__________
Appeal No. 1995-4273
Application 08/046,3641
__________
ON BRIEF
__________
Before WINTERS, WILLIAM F. SMITH, and LORIN, Administrative Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 1, 5
through 7, and 9, all the claims pending in the application. The claims on appeal read as
follows:
Appeal No. 1995-4273
Application No. 08/046,364
2
1. A composition comprising a microbead coupled with a plurality of binding
molecules which lack Fc portions and which are specific for CD2, CD3 or other T cell
receptor-linked components, CD4, CD5, or CD8.
5. A composition of claim 1, wherein the microbead is hydrophilic, stable, and
nonimmunogenic in humans, and resistant to hydrolysis in human body fluids.
6. A composition of claim 1, wherein the microbead is about 1 to 10 µm in
diameter.
7. A composition of claim 1, wherein the microbead is made by cross-linking
agarose or dextran.
9. A composition of claim 1, wherein the binding molecule is selected from the
group consisting of Fv, Fab, and F(ab’) of antibodies.2
The references relied on by the examiner are:
Goers et al. (Goers) 4,867,973 Sep. 19, 1989
J.M. Williams, et al. (Williams), “The Events of Primary T Cell Activation Can Be Staged by
Use of Sepharose-Bound Anti-T3 (64.1) Monoclonal Antibody and Purified Interleukin 1,”
Journal of Immunology, Vol. 135, No. 4, (1985), pp. 2249-2255.
T. Geppert, et al. (Geppert), “Accessory Cell Independent Proliferation of Human T4 Cells
Stimulated by Immobilized Monoclonal Antibodies to CD3,” Journal of Immunology, Vol.
138, No. 6, (1987), pp. 1660-1666.
Makinen, et al. (Makinen), Journal of Biological Chemistry, Vol. 264, (1989), pp. 3325-
3334.
Roitt, Immunology, Gower Medical Publishing (1995), page 8.7, figure 8.19.
Claims 1, 5 through 7, and 9 stand rejected under 35 U.S.C. § 103. As evidence of
obviousness, the examiner relies on Williams, Geppert, Makinen, Goers and Roitt.
Appeal No. 1995-4273
Application No. 08/046,364
3
Claims 1, 5 through 7, and 9 also stand rejected under 35 U.S.C. § 101 as being
inoperative, and under 35 U.S.C. § 112, first paragraph , as based on a non-enabling
disclosure. We reverse the rejection under 35 U.S.C. § 103. We do not reach the merits
of the rejections under 35 U.S.C. §§ 101 and 112, first paragraph, and remand this
application to the examiner for reevaluation of those rejections in light of U.S. Patent No.
5,872,222.
35 U.S.C.§ 103
All of the claims on appeal are directed to compositions comprising a microbead
coupled with a plurality of binding molecules specific for CD2, CD3, CD4, CD5, CD8, or
other T-cell antigens. Individual claims require that the microbead is nonimmunogenic in
humans; that the microbead is resistant to hydrolysis in human body fluids; that the binding
molecule is Fv, Fab, or F(ab’) ; etc. All of the claims, however, require that the binding2
molecules lack Fc portions.
Williams and Geppert each discloses activation of T-cells with anti-CD3 antibodies
bound to Sepharose, but neither discloses T-cell binding molecules lacking Fc portions.
Nor does the examiner rely on Makinen, Goers or Roitt to remedy this
deficiency. The statement of the rejection contains only an oblique reference to binding
molecules that lack Fc portions: “Fv, Fab and F(ab’)2 fragments of antibodies and
methods of producing these fragments are well known in the art.” See the Answer, page 5.
Appeal No. 1995-4273
Application No. 08/046,364
4
Appellant argues that the references teach nothing more than conjugates
comprising polymers coupled to intact anti-CD3 antibodies. In responding to these
arguments, the examiner does not dispute this. Instead, for a number of reasons set forth
on pages 15 through 17 of the Answer, the examiner maintains that “a person of ordinary
skill in the art would realize that the Fc region is only required when non-bound antibodies
are used in the in vivo system” and that person would also “have known that any argument
regarding Fc is a non-issue, and is textbook knowledge.”
Our determination of the patentability of the claims is hampered by the examiner’s
failure to specifically acknowledge or address this limitation in the statement of the
rejection. We have no doubt that the prior art could be modified in a manner consistent
with appellant’s specification and claims. That the prior art could be so modified, however,
would not have made the modification obvious unless the prior art suggested the
desirability of the modification. In re Gordon, 733 F.2d 900, 902, 221 USPQ 1125, 1127
(Fed. Cir. 1984). What is lacking from the examiner’s treatment of
the claims on appeal is a reason, suggestion or motivation, stemming from the prior art,
which would have led a person having ordinary skill to the claimed method. Pro-Mold &
Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1573, 37 USPQ2d 1626, 1629 (Fed.
Cir. 1996). In our judgment, the only reason or suggestion to modify the references to
arrive at the present invention comes from appellant’s specification.
Appeal No. 1995-4273
Application No. 08/046,364
5
Accordingly, the rejection of claims 1, 5 through 7, and 9 under 35 U.S.C. § 103 is
reversed.
35 U.S.C. §§ 101 and 112
U.S. Patent No. 5,872,222 (the ‘222 patent) issued from application serial no.
07/993,291, an application closely related to the present application. Claims 1 through 6
of the ‘222 patent read as follows:
1. A conjugate comprising a substantially nonimmunogenic polymer coupled
with a plurality of binding molecules, each being specific for an antigen on a
T cell, and said binding molecules lacking an Fc portion.
2. A conjugate of claim 1, wherein the binding molecule is selected from the
group consisting of Fv, Fab, and F(ab’) fragments.2
3. A conjugate of claim 1, wherein the antigen is CD2, CD3, CD4, CD5,
CD8, CD28, or a component associated with T cell receptor.
4. A conjugate of claim 1, wherein the nonimmunogenic polymer is
nonimmunogenic in humans and resistant to hydrolysis in human body fluids.
5. A conjugate of claim 1, wherein the nonimmunogenic polymer is
polyethylene glycol, cellulose, dextran, agarose, latex or an amino acid
copolymer.
6. A conjugate of claim 1, wherein the nonimmunogenic polymer is in the
form of a glutaraldehyde modified latex microbead.
It is apparent from a review of ‘222 that the patented conjugates and the conjugates
that are the subject of this appeal are closely related and parallel each
Appeal No. 1995-4273
Application No. 08/046,364
6
other. Thus it appears that the continued rejection of the claims in the present application
under 35 U.S.C. §§ 101 and 112, first paragraph, is inconsistent with the determination
that claims 1 through 6 of ‘222 are patentable. Accordingly, we remand the application to
the jurisdiction of the Examining Corps to allow the examiner to consider the ‘222 patent
and determine its effect, if any, on the issues raised in this appeal under 35 U.S.C. §§ 101
and 112, first paragraph.
This application, by virtue of its “special” status, requires an immediate action.
MPEP § 708.01(d). It is important that the Board be informed promptly of any action
affecting the appeal in this case.
REVERSED AND REMANDED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
WILLIAM F. SMITH ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
HUBERT C. LORIN )
Administrative Patent Judge )
Appeal No. 1995-4273
Application No. 08/046,364
7
vsh
Appeal No. 1995-4273
Application No. 08/046,364
8
Eric Mirabel
Tanox Biosystems, Inc.
10301 Stella Link #110
Houston, TX 77025-5497