Re-examination Ordered on "Expired" Harvard Oncomouse Patent

    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.

Comments

[Dan Feigelson]

Great story, Kevin. With the speed at which the PTO handles reexams, the odds are that the putative period of enforceability will expire before the reexam is decided - and certainly before the inevitable appeal of the reexam is decided. So will the PTO just drag its feet until 2012, then dismiss on grounds of mootness since the patent has expired and is no longer enforceable? That would set up an appeal only on the question of whether or not the TD applies and not the substantive validity questions; if the CAFC rules that it does not, then it's back to the PTO for a ruling on the merits. Let's hope the PTO changes it ways and deals with this one with the "special dispatch" it's supposed to, and rules on all aspects before it before 2012.

[Skeptical]

"and not the substantive validity questions;"

moot for lack of cause or controversy?