By Kevin E. Noonan —

On Monday, the U.S.
Patent and Trademark Office granted an ex parte reexamination request for U.S. Patent No. 5,925,803, the
latest-filed and last-granted member of the Harvard Oncomouse patent
family.  Remarkable about the
petition is that the third party requester (TPR), Ellen Gonzales of Gonzales
Patent Services, contends that the '803 patent has expired by operation of a
terminal disclaimer filed in an earlier-filed application, but maintains that despite
the putative expiration, the Office retains jurisdiction to consider the
re-examination request.

There are three claims
in the '803 patent, all directed to methods for testing a compound suspected to
be a carcinogen:

1.  A method of
testing a material suspected of being a carcinogen, comprising exposing a
transgenic mouse to said material and detecting neoplasms as an indication of
carcinogenicity, wherein the germ cells and somatic cells of said mouse contain
an activated oncogene sequence introduced into said mouse, or an ancestor of
said mouse, at an embryonic stage.

2.  A method of
testing a material suspected of conferring protection against the development
of neoplasms, said method comprising
    (1) providing a first
and a second transgenic mouse, the germ cells and somatic cells of which
contain an activated oncogene sequence introduced into said mice, or an
ancestor of said mice, at an embryonic stage,
    (2) treating said first
mouse with said material, and
    (3) detecting, as an
indication of said protection, a reduced incidence of development of neoplasms
in said first mouse, compared to the incidence in said second mouse, which is
not so treated.

3.  The method
of claim 1, further comprising exposing said first and second mice to a
carcinogen prior to, after, or simultaneously with treating said first mouse
with said material.

The TPR asserted six
substantial new questions (SNQ) of patentability against these claims:

• SNQ1:  Claim 1 of the '803 Subject Patent is obvious in
view of Claims 1, 11, and 12 of [grandparent U.S. Patent No. 4,736,866] in view
of Ward et al. or Schach et al. under the doctrine of judicially-created
obviousness-type double patenting.

• SNQ2:  Claims 1-3 of the '803 Subject Patent are unpatentable
in view of the Claims 1-12 of the '866 Grandparent Patent under the doctrine of
judicially-created obviousness-type double patenting.

• SNQ3:  Claims 2-3 of the '803 Subject Patent are
obvious in view of the claims of the '866 Grandparent Patent in view of the
Proctor Patent, under the doctrine of judicially-created obviousness-type double
patenting.

• SNQ4:  Claims 1-3 of the '803 Subject Patent are
obvious under 35 U.S.C. 103(a) in view of Schwab et al.

• SNQ5:  Claims 2-3 of the '803 Subject Patent are
obvious under 35 U.S.C. 103(a) over Jaenisch et al. in view of the Proctor
patent.

• SNQ6:  Claim 1 of the '803 Subject Patent is obvious
under 35 U.S.C. 103(a) over Jaenisch et al. in view of the either Ward et al.
or Schach et al.

TPR contends that the
following describes the priority chain and the relationship between the
grandparent '866 patent, parent U.S. Patent No. 5,087,571, and the '803
patent.  The '866 patent, according
to the TPR, contained claims 1-12 directed to the Harvard oncomouse; claims
13-19 directed to methods for testing a compound suspected of being a
carcinogen; and claims 20-22 directed to plasmid constructs; claim 1 is representative:

1.  A transgenic
non-human mammal all of whose germ cells and somatic cells contain a
recombinant activated oncogene sequence introduced into said mammal, or an
ancestor of said mammal, at an embryonic stage.

The TPR contends in her
request that the applicant cancelled the claims to the testing methods and let
claims to the Harvard Oncomouse proceed to grant as the '866 patent.

The application that
gave rise to the parent '571 patent, the TPR contends, was improperly
designated as a "divisional application," despite the fact that no
restriction requirement was raised against any of the claims of the '866 patent
and that the patentee voluntarily cancelled the testing method claims in the '866
patent as part of their patenting strategy.  This application was filed initially with original claims
13-24 that had been cancelled during prosecution of the '866 patent.  Prosecution of the '571 patent resulted
in two granted claims:

1.  A method of
providing a cell culture comprising
    (1) providing a
transgenic non-human mammal, all of whose germ cells and somatic cells contain
a recombinant activated oncogene sequence introduced into said mammal, or an
ancestor of said mammal, at an embryonic stage; and
    (2) culturing one or
more of said somatic cells.

2.  A cell
derived from a somatic cell obtained from a transgenic non-human mammal, all of
whose germ cells and somatic cells contain a recombinant activated oncogene
sequence introduced into said mammal, or an ancestor of said mammal, at an
embryonic stage which cell contains said recombinant activated oncogene
sequence.

Significantly,
applicants filed a terminal disclaimer over the claims of the '866 patent in
order to overcome an obviousness-type double patenting rejection raised against
these claims.  The following
language in the terminal disclaimer is important for the arguments successfully
raised in the request (with emphasis
added):

Your
petitioner, President and Fellows of Harvard College, hereby disclaims any
portion of an patent granted on the above-identified application or on any application which is entitled to
the benefit of the filing date of this application under 35 U.S.C. 120 not
extending the term of any patent granted on that application beyond the term of
issued U.S. Patent No. 4,736,866 issued April 12, 1988.

The TPR contended that
this language was not required in a terminal disclaimer and the patentees were
bound by it (i.e., that it cannot be
rescinded by certificate of correction, reissue, or reexamination, even if it
was filed in error).  As in the '866
patent, patentees cancelled the testing method claims in the application that
granted as the '571 patent.

The application that
granted as the '803 patent was the first member of the priority chain having a
restriction requirement, which was filed with claims 1-13 and 15-24 of the
grandparent application.  This
restriction requirement identified three groups:  claims 1-12 and 15-17,
directed to a transgenic animal and methods for producing such an animal;
claims 13, 18 and 19, drawn to suspected carcinogen testing methods; and claims
20-24 being drawn to plasmids; applicants elected to prosecute the testing method claims.  During prosecution the applicants
overcame an obviousness rejection based on the '866 patent and the Ward and Schah
references on the grounds that 35 U.S.C. § 121 "prohibits the USPTO from
rejecting a later divisional application 'where (as here) the divisional
application is filed as the result of a restriction requirement in the original
case.'"  The TPR contended
that this statement is inaccurate, insofar as there was no restriction
requirement issued during prosecution of either the grandparent '866 patent or
the '571 patent.

The TPR argued in the
request that the '803 patent expired by operation of the terminal disclaimer
filed in the '571 patent on July 12, 2005, the expiration date of the '866
patent.  Reexamination is
still proper, she contended, because a reexamination "may be declared for
an expired patent at any time during the enforceability
of the patent" (emphasis in
original), which will run until July 12, 2011 (i.e., six years after the
patents expiration date; M.P.E.P. § 2211).  Moreover, a question arising as a result of obviousness-type double
patenting is appropriate for raising a substantial new question of patentability
in a reexamination (M.P.E.P. § 2217).  Finally, the TPR argued that public policy concerns supported the Office
granting her request for reexamination:

TPR
respectfully requests that a Reexamination nonetheless be declared to serve the
public notice function of Reexaminations (i.e., to make it clear on the record
that the '803 Subject Patent is only avoiding the double-patenting rejections because
of the terminal disclaimer in the '571 Parent Patent, which likewise
informs the public that the patent expired on July 12, 2005).  In such a case,
even if a Reexamination is not declared, to serve the public notice function,
TPR respectfully requests that the Patent Office indicate in writing that the
terminal disclaimer in the '571 Parent Patent application insulates the '803
Subject Patent from obviousness type double patenting rejections, and further,
affirmatively state that the '803 Subject Patent therefore expired on July 12,
2005.  This public notice function is particularly important in this case as the
Patentee is publicly advertising that the '803 Subject Patent does not expire
until July of 2016, which is 11 years past the actual expiration date.

The Office agreed.  As set forth under Reexamination
Control No. 90/010,955, the Office granted the reexamination based on all six
substantial new questions of patentability.  Although the paper granting the request cited revisions to
the reexamination statute (35 U.S.C. § 301 et
seq.) enacted by Congress in 2002 in response to the Federal Circuit's
decision in the In re Portola Packaging
case, which permit a reexamination request to be granted on art considered by
the Office during ex parte
prosecution provided that a substantial new question of patentability is
raised, the paper also notes that all of the art cited by the TPR (except for
the Ward reference) had not been
considered by the examiner during prosecution of the '803 patent.  Moreover, the Office did not separately
address the standing issue raised by the TPR, apparently agreeing that a
reexamination is properly granted on an expired patent during the period where
the patent right can be enforced.

The reexamination will
be considered by Primary Examiners Brenda Brumback, Padmashri Ponnaluri, and SPE
Deborah Jones.