By
Donald Zuhn —

In
a 2-1 decision issued earlier today, the Federal Circuit affirmed a determination
by the Board of Patent Appeals and Interferences upholding the rejection of the
claims of U.S. Application No. 10/650,509 for obviousness-type double patenting
over U.S. Patent No. 7,601,685.  The '509 application, which is assigned to
the California Institute of Technology (Caltech), is directed to matrices
containing bidomain peptides or proteins. 
Claim 18 of the '509 application recites "[a] bidomain protein or
peptide comprising a transglutaminase substrate domain and a polypeptide growth
factor."  The named inventors on the
'509 application are Jeffrey Hubbell, Jason Schense, Andreas Zich, and Heike
Hall, all of whom were affiliated with Caltech at the time the claimed invention
of the '509 application was made.

In
1998, some five years before the '509 application was filed, Dr. Hubbell moved
from Caltech to Eidgenössische Technische Hochschule Zürich (ETH Zürich).  In 2002, the application that issued as the
'685 patent was filed.  The '685 patent,
which is jointly assigned to ETH Zürich and Universitat Zurich, lists Dr.
Hubbell, Dr. Schense, and Shelly Sakiyama-Elbert as inventors (Anna Jen is also
listed as an inventor on a Certificate of Correction).  Thus, the '509 application and '685 patent do
not have common inventive entities or common owners.  Claim 1 of the '685 patent recites:

1.
A fusion protein, comprising:
    (i)
a first protein domain;
    (ii)
a second protein domain; and
    (iii)
an enzymatic or hydrolytic cleavage site between the first and the second
domains;
    wherein
the first domain is a growth factor selected from the group consisting of the
platelet derived growth factor superfamily and the transforming growth factor
beta (TGFβ) superfamily;
    wherein
the second domain is a crosslinking Factor XIIIa substrate domain;
    wherein
the enzymatic cleavage site is selected from the group consisting of
proteolytic substrates and polysaccharide substrates, and
    wherein
the hydrolytic cleavage site comprises a substrate with a linkage which
undergoes hydrolysis by an acid or a base catalyzed reaction.

During
prosecution, the Examiner rejected the claims of the '509 application for
obviousness-type double patenting over, inter
alia, the application that issued as the '685 patent.  In particular, the Examiner determined that
the conflicting claims in the '685 patent were directed to species of the
claimed invention of the '509 application and therefore anticipated the claimed
invention of the '509 application.  On
appeal, the Board affirmed the Examiner's obviousness-type double patenting
rejection over the '685 patent, determining that claim 1 of the '685 patent
recites a protein that contains both of the features required in rejected claim
18, and that claim 18's use of the term "comprising" allowed for
inclusion of the additional elements recited in claim 1 of the '685 patent.  The Board also rejected Appellants' argument
that common ownership was a requirement for obviousness-type double patenting,
citing MPEP § 804(I)(A), which states that "[d]ouble patenting may exist
between an issued patent and an application filed by the same inventive entity,
or by a different inventive entity having a common inventor, and/or by a common
assignee/owner."  Appellants
appealed the Board's affirmance of the Examiner's rejection to the Federal
Circuit.

On
appeal before the Federal Circuit, Appellants argued that obviousness-type double patenting should not
apply where an application and a conflicting patent share common inventors but
do not have identical inventive entities, were never commonly owned, and are
not subject to a joint research agreement. 
Alternatively, Appellants argued that they should be allowed to file a
terminal disclaimer as an equitable measure, or that the Court should employ a
two-way obviousness analysis for the rejected claims.  The U.S. Patent and Trademark Office
countered that (1) whether the '509 application and '685 patent were ever
commonly owned was immaterial to the policy of preventing harassment by multiple
assignees; (2) identity of inventors is not required where there is an overlap
in the inventors; (3) Appellants had not established any grounds upon which
they should be allowed to file a terminal disclaimer; and (4) Appellants were
not entitled to a two-way obviousness analysis because they admitted to being
partially responsible for the delay that caused the '685 patent claims to issue
first.

Noting
that the Board's affirmance was based in part on § 804(I)(A) of the MPEP, Judge
O'Malley, writing for the majority, indicated that "the MPEP standard is
consistent with the rationale we have used to support application of
obviousness-type double patenting rejections."  The rationale being the concern over potential harassment of an infringer by multiple assignees asserting essentially the same patented invention (as well as preventing unjustified extension of the right to exclude).  Judge O'Malley also noted that it had
previously rejected Appellants' argument that obviousness-type double patenting
should never be applied in the absence of common ownership in two other cases:  In re
Van Ornum, 686 F.2d 937 (CCPA 1982), where an obviousness-type double
patenting rejection over a patent with a common inventor but no common
ownership was affirmed, and In re Fallaux,
564 F.3d 1313 (Fed. Cir. 2009), where the reference patents and application at
issue were related only by way of a single common inventor.  Although Appellants argued that Van Ornum and Fallaux were distinguishable because in those cases the
applications at issue were once commonly owned, the majority noted that
"the potential for harassment by multiple assignees would [still]
exist," and therefore "[Appellants'] distinction does not alleviate
the underlying harassment concerns here." 
The majority also refused Appellants' invitation to create a specific
exception barring application of obviousness-type double patenting in instances
where the conflicting claims share only common inventors, rather than common
ownership, declaring that "[w]e too can find no reasoned basis to
differentiate between cases involving identical 'inventive entities' and those
where the inventive entities are almost identical when assessing obviousness-type
double patenting rejections."

The
majority also refused to create a new equitable right to resort to terminal
disclaimers in cases such as this one. 
Finally, with regard to Appellant's argument that the rejected claims should
be reconsidered under a two-way obviousness analysis, rather than the standard
one-way test, the majority noted that "the two-way test is appropriate
only in the 'unusual circumstance' where 'the PTO is solely responsible for the
delay in causing the second-filed application to issue prior to the
first.'"  In the instant case,
Appellants "cannot establish that the PTO is solely responsible for any
delays associated with the claims on appeal," because Appellants' counsel
before the Board "specifically conceded that Hubbell was partially
responsible for the delay that caused the '685 patent to issue before the
application claims," and as the majority explained:

[T]he record reveals that, in June 2003, the
examiner allowed claims very similar to those at issue on appeal.  Rather than permitting those claims to issue,
[Appellants] failed to pay the issue fee, let the '918 application claims go
abandoned, and filed the '509 application in August 2003.  These prosecution choices resulted in the foreseeable
consequence that the '685 patent issued before the application claims on
appeal.

Writing
in dissent, Judge Newman begins by pointing out that:

In accordance with the law of double
patenting, double patenting does not apply when the application and patent are
of separate ownership and have separate inventive entities.  In such situation the appropriate examination
path is on the merits of the invention, or through the interference or
derivation procedures, or other standard protocol as may apply in the
particular situation.  . . .  This court need not create a new protocol wherein
the contributions of distinct entities and separate ownership are rejected for
"double patenting" instead of examined under the established rules.

The court today not only finds "double
patenting" when there is neither common inventorship nor common ownership,
but having so found withholds the standard remedy of the terminal disclaimer,
and simply denies the application.  This
novel ruling is contrary to statute and precedent, with no policy justification
for changing the law.

Following
a short discussion of the evolution of the law of double patenting, Judge
Newman concludes that:

The panel majority does not dispute that
these are different inventive entities and that there is not common
ownership.  However, the court rules that
obviousness-type double patenting applies. 
If there indeed is obviousness-type double patenting, then a terminal
disclaimer is necessarily available.  However,
the court rules that a terminal disclaimer is not available because there is
not common ownership.  Yet if there is
not common ownership or common inventorship, there cannot be double patenting.  On this circularity, the court denies the
CalTech application on the ground of double patenting.

Noting
that there was "no suggestion of any attempt to 'game' the system,"
Judge Newman ends her dissent by noting that unlike the majority, she would not
have foreclosed Caltech's request for equitable relief in the form of
authorization to file a terminal disclaimer.

In re Hubbell (Fed. Cir. 2013)
Panel:
Circuit Judges Newman, O'Malley, and Wallach
Opinion
by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Newman