Ex parte Jones

Board of Patent Appeals and Interferences

Jun 26, 2000

07624053 (B.P.A.I. Jun. 26, 2000)

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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(2) is not binding precedent of the Board.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. 34
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte C. MICHAEL JONES
__________
Appeal No. 1996-0848
Application 07/624,053
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ON BRIEF
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Before WINTERS, DOWNEY, and ROBINSON, Administrative Patent Judges.
ROBINSON, 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 16-22, 24-25, 27-32, 34-35, and 42, all of the claims pending in the
application. Claims 22, 25, and 42 are illustrative of the claims on appeal and read as
follows:
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Application 07/624,053
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22. A continuous cell line producing a human monocyte cytotoxicity inducing
factor, the factor characterized by the following properties:
(a) capability of inducing human monocytes to a cytotoxic state;
(b) retention of biological activity following treatment at pH 2 for one hour;
(c) retention of biological activity following treatment at 60 C for one hour;B
(d) ability to bind to Matrex Gel Red A under low-salt conditions and elute
from Matrex Gel Red A under high-salt conditions; and
(e) retention of biological activity in the presence of antiserum to interferon
gamma, interferon alpha, or a combination of anti-sera to interferon alpha
and gamma.
25. A continuous cell line which produces a factor capable of inducing human
monocytes to a cytotoxic state, the continuous cell line being produced by a process
comprising the steps of:
(a) immortalizing human T-cells to produce continuous cell clone;
(b) identifying a clone which produces a human monocyte cytotoxicity inducing factor
having the following properties:
i) capability of inducing human monocytes to a cytotoxic state;
ii) retention of biological activity following treatment at pH 2 for one hour;
iii) retention of biological activity following treatment at 60 C for one hour; B
iv) ability to bind to Matrex Gel Red A under low-salt conditions and elute
from Matrix Gel Red A under high-salt conditions; and
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v) retention of biological activity in the presence of anti-serum to
interferon gamma, interferon alpha, or a combination of anti-sera to
interferon alpha and gamma; and
(c) culturing the clone to produce the continuous cell line.
42. A method of generating a continuous cell line which produces a factor
capable of inducing human monocytes to a cytotoxic state, the method comprising the
steps of:
(a) immortalizing human T-cells to produce continuous cell clones;
(b) identifying a clone which produces a factor having the following
characteristics:
i) capability of inducing human monocytes to a cytotoxic state;
ii) retention of biological activity following treatment at pH 2 for one
hour;
iii. retention of biological activity following treatment at 60 C for one B
hour;
iv. ability to bind to Matrex Gel Red A under low-salt conditions and
elute from Matrex Gel Red A under high-salt conditions; and
v. retention of biological activity in the presence of anti-serum to
interferon gamma, interferon gamma, interferon alpha, or a
combination of anti-sera to interferon alpha and gamma; and
(c) culturing the clone to produce the continuous cell line.
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Application 07/624,053
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The reference relied upon by the examiner is:
Jones et al. (Jones), "Monocyte Cytotoxicity Factor (MCF) Production by Human T-cell
Hybridoma," Immunobiol., vol. 167, abstract no. 365 (1984).
Grounds of Rejection
Claims 16-22, 24-25, 27-32, 34-35, and 42 stand rejected under 35 U.S.C. § 112, first
paragraph, as being based on a non-enabling disclosure.
Claims 16-22, 24-25, 27-32, 34-35, and 42 stand rejected under 35 U.S.C. § 112,
second paragraph, as failing to particularly point out and distinctly claim the invention.
Claims 16-22, 24-25, 27-32, 34-35, and 42 stand rejected under 35 U.S.C. § 102 (b).
As evidence of anticipation, the examiner relies upon Jones.
We reverse.
Background
The applicant describes the invention, as presently claimed, at page 9 of the
specification as being directed to a continuous cell line, as well as a method of generating
a continuous cell line, which produces a human monocyte cytotoxicity inducing factor
(MCF) that is capable of inducing human monocytes to a cytotoxic state, wherein the cell
line is produced by a process which includes the steps of immortalizing human T-cells to
produce continuous cell clones, identifying a clone which produces the factor, and culturing
the clone to provide the continuous cell line.
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Discussion
The rejection under 35 U.S.C. § 112, first paragraph
Claims 16-22, 24-25, 27-32, 34-35, and 42 stand rejected under 35 U.S.C.
§ 112, first paragraph, as failing to provide an enabling disclosure for the full scope of the
claimed invention.
To the extent that we understand the examiner's reasoning, this rejection is based
on the examiner's determination that the claims read on subject matter not enabled by the
specification. The examiner notes that pages 18 and 32-34 of the specification describe
the identification of MCF-positive clones and urges that the claimed cell lines are identified
as producing factor or factors that stimulate monocyte cytotoxicity, which are not
necessarily the single factor described in the specification. The examiner thus concludes
that the claimed invention is broader than the enabling disclosure. (Answer, page 8 and
Supplemental Answer, page 4).
While we would agree that the claims on appeal are not necessarily limited to a cell
line which produces a specific monocyte stimulating factor, on the record before us, the
examiner has failed to make any of the factual findings which would reasonably support a
rejection under the enablement requirement of 35 U.S.C. § 112, first paragraph. See In re
Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). We, therefore, reverse the
Appeal No. 1996-0848
Application 07/624,053
In setting forth the basis of this rejection the examiner states that the rejection of 1
"claims 22-35" still stands. (Second Supplemental Answer, page 2). Manifestly, that
reference constitutes an inadvertent error. Since each independent claim includes at least
one form of the terminology on which the rejection is based, we have assumed the
rejection is applicable to all of the appealed claims.
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rejection under 35 U.S.C. § 112, first paragraph.
The rejection under 35 U.S.C. § 112, second paragraph
Claims 16-22, 24, 25, 27-32, 34, 35, and 42 stand rejected under 35 U.S.C.
§ 112, second paragraph, as failing to particularly point out and distinctly claim the
invention. The examiner urges that the terms “producing” “produces” “produced” and1
“secretes” refer to the production of MCF and the claims are unclear and do not particularly
point out the invention since the cells are not capable of producing the factor in the
absence of the mitogen and the claims do not reflect the presence of the mitogen.
(Answer, page 10; Second Supplemental Answer, page 2).
The examiner has the initial burden of demonstrating indefiniteness of the claims. In
re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). In our
opinion, this rejection falls by its own weight. The language of the claims indicates that the
claimed cell line produces the factor. If a cell line is incapable of producing the described
factor, it does not fall within the scope of the claims before us. We point out that it is well
established that "definiteness of the language employed must be analyzed, not in a
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vacuum, but always in light of the prior art and of the particular application disclosure as it
would be interpreted by one possessing the
ordinary level of skill in the pertinent art." In re Moore, 439 F.2d 1232, 1235,
169 USPQ 236, 238 (CCPA 1971). We note that the purpose of the second paragraph of
Section 112 is to basically insure, with a reasonable degree of particularity, an
adequate notification of the metes and bounds of what is being claimed. See In re
Hammock, 427 F.2d 1378, 1382, 166 USPO 204, 208 (CCPA 1970). When viewed in
light of this authority, we do not agree with the examiner that the metes and bounds of the
rejected claims would not be capable of being determined when read in light of the
specification and as one skilled in this art would interpret them. Here, one reading the
claims in light of the specification would readily appreciate that the cells must be contacted
with a mitogen in order to stimulate the production of the factor. However, the failure of the
claims to explicitly state this information does not make the scope of the claims unclear.
We, therefore, reverse the rejection of claims 16-22, 24, 25, 27-32, 34, 35, and 42 under
35 U.S.C. § 112, second paragraph.
The rejection under 35 U.S.C. § 102(b)
In rejecting claims 16-22, 24, 25, 27-32, 34, 35, and 42 under 35 U.S.C.
§ 102(b) as unpatentable over Jones, the examiner urges (Answer, page 8):
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[t]he reference teaches production of a human T cell
hybridoma and cell lines, derived from Szeary’s syndrome
patients. The reference teaches the use of a mitogen and
production of MCF, which inherently falls within the claimed
weight ranges.
Appellant urges that Jones fails to provide an enabling disclosure and thus can not
be prior art sufficient to render the appealed claims unpatentable. In support of this
position, appellant provides the declaration of Dr. Jones filed July 20, 1989 during the
prosecution of a related application. (Revised Principal Brief, Exhibit H). The examiner
urges that these arguments and evidence are not persuasive since (Answer, page 11):
[t]he declaration does not specifically address why the abstract
does not teach a method of generating a continuous cell line
that has the capacity of producing a factor.
Yet, our reading of the declaration would indicate that appellant has pointed to several
deficiencies of the Jones abstract (Reply Brief, pages 24-25) which appear relevant to the
question of whether Jones is enabling for that which it discloses.
One such point goes to the question of whether the disclosure that "a population of
uniformly OKT4 lymphocytes was isolated by differential centrifugation over Percoll"+
(Jones, lines 7-8) is sufficient to permit those of ordinary skill in this art to actually isolate
and identify those lymphocytes present which produce the MCF as required by the claimed
invention. The Jones Declaration at page 3 states:
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The abstract does not teach how one would successfully carry
out the Percoll gradient fractionation of T-cells so as to identify
a fraction containing a subset of T-cells which produces MCF
material.
This limited disclosure in Jones is contrasted with the specification which reasonably
appears to provide detailed instructions at pages 23-34 as to how the cells lines are
generated and provides specific information as to identifying and isolating those which
produce MCF.
In addition, Dr. Jones indicates that the abstract erroneously indicates that the
factor can be precipitated from the supernatant with 30-50% ammonium sulfate, which was
subsequently found to result in the loss of virtually all of the associated biological activity
which "would make it impossible to detect activity in any subsequent isolation steps and/or
to obtain a final product with sufficient biological activity to be of use pharmacologically."
(Exhibit H, Declaration, page 6). The examiner does not dispute this point. Yet, if
appellant is correct that use of the precipitation step described by Jones would eliminate
the very biological activity sought, then the reference cannot reasonably be considered to
place that aspect of the invention in the hands of the public.
We agree with appellant that before a prior art disclosure can preclude an applicant
from obtaining a patent, that prior art disclosure must contain an enabling disclosure. In re
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Hoeksema, 399 F. 2d 269, 273, 158 USPQ 596, 600 ("[I]t is sound law, consistent with the
public policy underlying our patent law, that before any publication can amount to a
statutory bar to the grant of a patent, its disclosure must be
such that a skilled artisan could take its teachings in combination with his own knowledge
of the particular art and be in possession of the invention.") (citation omitted). Here, the
examiner has failed to come to grips with the specific points raised by appellant's
arguments and the declaration evidence presented to demonstrate that the prior art relied
upon by the examiner would not have been enabling. It is the initial burden of the patent
examiner to establish that claims presented in an application for a patent are unpatentable.
In re Oetiker, 977 F.2d 1443, 1446, 24 USPQ2d 1443, 1445 (Fed. Cir. 1992). However,
the burden on the examiner does not end there. Where, as here, the appellant provides
arguments and evidence in support of patentability of the rejected claims, the examiner
must step back and consider anew the question of whether the claims are properly
rejected having weighed the evidence and arguments made of record in support of
patentability against those in support of unpatentability. See In re Hedges, 783 F.2d 1038,
1039, 228 USPQ 685, 685-86 (Fed. Cir. 1986);
In re Rinehart, 531 F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 1976); In re Piasecki,
745 F.2d 1468, 1471, 223 USPQ 785, 788 (Fed. Cir. 1984). On balance, we find the
Appeal No. 1996-0848
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arguments and evidence presented by appellant outweigh the arguments and facts
provided by the examiner as to the question of whether Jones provides an enabling
disclosure which would have placed the claimed invention in the hands of the public. Thus,
we find that the examiner has failed to establish prima facie case of anticipation
within the meaning of 35 U.S.C. § 102(b). Therefore, the rejection of claims 16-22, 24, 25,
27-32, 34, 35, and 42 under 35 U.S.C. § 102(b) is reversed.
SUMMARY
To summarize, the decision of the examiner to reject claims 16-22, 24, 25,
27-32, 34, 35, and 42 under 35 U.S.C. § 112, first paragraph is reversed. The decision of
the examiner to reject claims 16-22, 24, 25, 27-32, 34, 35, and 42 under 35 U.S.C.
§ 112, second paragraph is reversed. The decision of the examiner to reject claims 16-
22, 24, 25, 27-32, 34, 35, and 42 under 35 U.S.C. § 102(b) is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Appeal No. 1996-0848
Application 07/624,053
12
MARY F. DOWNEY )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
DOUGLAS W. ROBINSON )
Administrative Patent Judge )
DR/dm
Arnold, White & Durkee
P.O. Box 4433
Houston, TX 77210