Ex Parte Fallaux et al

Board of Patent Appeals and Interferences

Jun 17, 2008

10618526 (B.P.A.I. Jun. 17, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FRITS JACOBUS FALLAUX, ROBERT CORNELIS HOEBEN,
ALEX JAN VAN DER EB, ABRAHAM BOUT, and DOMENICO
VALERIO
__________

Appeal 2008-22511
Application 10/618,526
Technology Center 1600
__________

Decided: June 17, 2008
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
adenovirus packaging cell which the Examiner has rejected under the
judicially created doctrine of obviousness type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Heard May 22, 2008.
Appeal 2008-2251
Application 10/618,526

Background
“Gene therapy is a recently developed concept for which a wide range
of applications can be and have been envisioned” (Spec. 1). The
Specification notes that “[f]or the purpose of gene therapy, adenoviruses
carrying deletions have been proposed as suitable vehicles for genetic
information” (Spec. 2). The Specification indicates that “all adenovirus
vectors currently used in gene therapy are believed to have a deletion in the
E1 region, where novel genetic information can be introduced. The E1
deletion renders the recombinant virus replication defective” (Spec. 4).
Appellants teach that “we have developed packaging cells that have
no overlapping sequences with a new basic vector and thus are suited for
safe large scale production of recombinant adenoviruses” (Spec. 6).
Statement of the Case
The Claims
Claims 1, 3-7, 10, 11, 16, and 21-25 are on appeal. We will focus on
claim 1, which is representative and reads as follows:

1. An isolated adenovirus packaging cell comprising in
its genome:
a first nucleic acid sequence encoding adenovirus
E1A and E1B gene products but lacking a nucleic acid
sequence encoding adenovirus pIX.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Vogels US 6,340,595 B1 Jan. 22, 2002
Vogels US 6,413,776 B1 Jul. 2, 2002
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The issues
The rejection as presented by the Examiner is as follows:
Claims 1, 3-7, 10, 11, 16, and 21-25 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 43 and 44 of U.S. Patent 6,340,595 and claims 7, 32, and 35 of
U.S. Patent 6,413,776.
Judicially Created Obviousness Type Double Patenting rejection
Appellants raise two issues: whether the obviousness test employed
should be the one way or two way test and whether the requirement for a
terminal disclaimer to prevent harassment by multiple assignees is
applicable.
Appellants argue that “the Federal Circuit found a two-way
obviousness test appropriate under the very same circumstance relied upon
for disqualification of the two-way test in this case” (App. Br. 11).
Appellants state the “present application discloses an invention, PER.C6
cells, which was used in separate inventions filed in applications in July
1999 and June 1998, which issued as the '595 and '776 patents in January
and July of 2002, respectively” (App. Br. 11). Appellants then contend that
the “ODP rejection at issue, being based upon a one-way patentability test,
ignores the precedent of In re Braat[, 937 F.2d 589, 590 (Fed. Cir. 1991)].
The claims on appeal are entitled to a two-way obviousness test as a matter
of law” (App. Br. 11).
Appellants contend that “37 C.F.R. § 1.321(c) cannot rationally be
applicable in the absence of common ownership. Otherwise, Appellant is
placed in an unwarranted ‘catch 22’ situation, being both required and
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forbidden to assert an ownership interest in the reference patent claims”
(App. Br. 7-8). Appellants further argue that harassment by multiple
assignees “cannot reasonably stand alone as justification for an ODP
rejection” (App. Br. 8).
The Examiner responds that “[i]t does not logically follow from this
rule [37 C.F.R. § 1.321(c)] that lack of common ownership obviates an
obviousness-type double patenting rejection. Furthermore, the applications
of the reference patents had been commonly assigned with the parents of the
instant application” (Ans. 4).
The Examiner also contends that
[t]here is no evidence of record that the PTO prevented
Appellant from including the instant claims in any of these
earlier patents during their prosecution. This earlier issuance
of patents over which the instant claims were obvious under
obviousness-type double patenting doctrine shows that there
was no administrative delay by the PTO that caused earlier
issuance of applications with later effective filing dates. The
instantly claimed subject matter could have been claimed
and been issued in any of these earlier patents. Appellant has
been solely in control of the delay in prosecution of the
instant claims. Consequently, the "one- way" patentability
test is applicable here, not the "two-way" test.

(Ans. 5.)
In view of these conflicting positions, we frame the judicially created
double patenting issues before us as follows:
(1) Does the one way or two way test for obviousness type double
patenting apply?
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(2) Does the prerequisite in 37 C.F.R. § 1.321(c) for common
ownership preclude requiring a terminal disclaimer when there is no
common ownership?
Findings of Fact
1. Claims 43 and 44 of U.S. Patent 6,340,595 and claims 7, 32,
and 35 of U.S. Patent 6,413,776 claim the use of PER.C6 cells which are
rejected as anticipating, and therefore rendering obvious under the judicially
created doctrine of double patenting, the currently claimed invention (see
claims 43 and 44 of U.S. Patent 6,340,595 and claims 7, 32, and 35 of U.S.
Patent 6,413,776). Appellants “acknowledge[] that the final rejections can
be viewed as being in literal harmony with Chart II-B of § 804” (App. Br.
5).
2. The Examiner determined that the instant claims do not render
claims 43 and 44 of U.S. Patent 6,340,595 and claims 7, 32, and 35 of U.S.
Patent 6,413,776 obvious under a two-way test (Final Rejection 3/01/2006
8).
3. The instant application claims direct priority from U.S. patent
application 08/793,170 which was filed March 25, 1997 and issued as U.S.
Patent 5,994,128 on November 30, 1999 (see Spec. 2).
4. The Vogel ‘595 patent claims priority to U.S. patent application
09/097,239, which was filed on June 12, 1998 and the Vogel ‘595 patent
was itself filed on July 21, 1999 and issued on January 22, 2002 (see Vogel
‘595).
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5. The Vogel ‘776 patent was filed as U.S. patent application
09/097,239, which was filed on June 12, 1998 and the Vogel ‘776 patent
issued on July 2, 2002 (see Vogel ‘776).
6. The Vogel ‘776 and ‘595 patents are not commonly owned with
the instant application (App. Br. 4).
Discussion of Judicially Created Obviousness Type Double Patenting
rejection
(i) One-way test or two-way test?
Appellants contend that the “ODP rejection at issue, being based upon
a one-way patentability test, ignores the precedent of In re Braat. The claims
on appeal are entitled to a two-way obviousness test as a matter of law”
(App. Br. 11). We do not agree. When the Federal Circuit addressed this
issue in In re Berg, 140, F.3d 1428, 1431-33 (Fed. Cir. 1998), the court
stated that the two-way test is a narrow exception to the general rule of the
one-way test, and that the two-way test applied when a later-filed
improvement patent issues before an earlier filed basic invention. In Berg,
the court answered the question of when the two-way test should apply and
answered “[w]e hold, therefore, that if an applicant can file all of its claims
in one application, but elects not to, it is not entitled to the exception of the
two-way test.” In re Berg, 140 F.3d at 1434.
We find that Appellants have presented no evidence or reason why the
current claims could not have been filed in the original application in this
series, U.S. patent application 08/793,170 which was filed March 25, 1997,
which would have predated either of the Vogel patents (see FF 3-5). Since
the current application is a direct child, with no continuations in part, from
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08/793,170, the specification of that application necessarily provides the
identical support to the claims as that provided by the instant specification.
Appellants do not dispute that the one-way test would support double
patenting, only arguing that the two-way test applies (FF 1-2).
Additionally, Appellants have not provided any evidence that the rates
of prosecution were dictated by the USPTO. In fact, the evidence of record
clearly shows that Appellants dictated the rates of prosecution, choosing to
file some subject matter in U.S. application 08/793,170 filed March 25,
1997, other subject matter in a U.S. application 09/334,765, filed June 16,
1999 which was a continuation of 08/793,170, additional subject matter in
U.S. application 09/506,548, filed February 12, 2000, and continuing filing
in U.S. applications 10/124,414 and 10,125,751, filed April 18, 2002, as
well as the instant 10/618,526 filed July 11, 2003 (see Spec. 2). Two of
these applications matured into patents prior to the issuance of either Vogel
‘595 or Vogel ‘776 and several of the other applications were filed prior to
the issuance of the Vogel ‘595 and Vogel ‘776 patents.
Berg clearly requires that the “two-way exception can only apply
when the applicant could not avoid separate filings, and even then, only if
the PTO controlled the rates of prosecution to cause the later filed species
claims to issue before the claims for a genus in an earlier application.” Berg,
140 F.3d at 1435. Even if we concede that Appellants could not have
avoided separate filings, due to the difference in inventorship, Appellants
have provided no evidence that the USPTO controlled the rate of
prosecution and the evidence of Appellants filings does not support such a
finding.
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We conclude that the Examiner properly applied the one-way test in
light of the Federal Circuit’s guidance in Berg.
(ii) Common Ownership
Section 1.321(c)(3) of 37 CFR requires a terminal disclaimer filed to
overcome an obvious-type double patenting rejection include a statement
that the patent shall be enforceable only as long as both patents are
commonly assigned. This requirement reflects a concern that issuing patents
on patentably indistinct inventions to separate patent owners may subject a
purported infringer to harassment by multiple suits. In re Van Ornum, 686
F.2d 937, 945 (CCPA 1982) (upholding the PTO's non-alienation
requirement in former 37 CFR § 1.321(b)). Strong policies dictated the
creation of this principle governing the co-expiration and co-ownership of
sufficiently related patents. Pharmacia Corp. v. Par Pharmaceutical Inc.,
417 F.3d 1369, 1374 (Fed. Cir. 2005), citing In re Griswold, 365 F.2d 834
(CCPA 1966) (noting the co-ownership requirement is a creative solution to
potential harassment suits from two separate patents).
Indeed, the regulatory history of § 1.321 shows that the common
ownership provision was added to specifically address the potential
harassment of possible infringers by multiple suits:
This provision would prevent harassment of an alleged
infringer by multiple parties due to subsequent different
ownership of multiple patents granted as the result of filing a
terminal disclaimer to overcome a double patenting
rejection.

Notice of Proposed Rule Making, Conflicting Claims, 35 Fed. Reg. 20011,
20012 (December 31, 1970). The requirement for common ownership was
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promulgated as part of 37 CFR § 1.321(b) (1971); Final Rule, Conflicting
Claims, 36 Fed. Reg. 7312, 7312 (April 17, 1971). Section 1.321(b) is the
predecessor of current § 1.321(c)(3).
The common ownership provision has been held to be a valid exercise
of the Director's rule making authority in administering the statutory
provision. Van Ornum, 686 F.2d at 944-48. As made clear by both the
regulatory history of § 1.321 and the Van Ornum opinion, the requirement
for common ownership addresses the problem of multiple infringement suits
based on separate patents on patentably indistinct inventions. Interpreting
the rule to permit inventions that should be subject to double patenting
rejections to exclude those who lack common ownership would allow the
exact situation that the regulation was intended to avoid. See In re Van
Ornum, 686 F.2d 937, 948 (CCPA 1982)(“Upon this extensive review of the
situation, we consider it desirable to tie both the termination and the
ownership of the two patents together”).
Appellants concede that the instant application and the Vogel ‘595
and Vogel ‘776 patents are not commonly owned (see App. Br. 4).
Accordingly, we hold that under the facts of this case the instant application
and the Vogel ‘595 and Vogel ‘776 patents are not commonly owned as that
phrase is used in 37 CFR § 1.321(c)(3). Since the terminal disclaimer must
state that any patent granted on the application being examined will be
enforceable only for and during the period that it and the patent to which the
disclaimer is directed or the patent granted on the application to which the
disclaimer is directed are commonly owned, Appellants are precluded from
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overcoming the double patenting rejection by filing a terminal disclaimer.
See 37 CFR § 1.321(c); MPEP § 706.02.
Appellants argue that “37 C.F.R. § 1.321(c) cannot rationally be
applicable in the absence of common ownership. Otherwise, Appellant is
placed in an unwarranted ‘catch 22’ situation, being both required and
forbidden to assert an ownership interest in the reference patent claims”
(App. Br. 7-8). We do not agree. Appellants created the “catch 22”
themselves, by choosing to delay submitting the instant claims for more than
six years from the original filing date of March 25, 1997. Had Appellants
filed these claims in U.S. Application 08/793,170, either the claims would
have issued prior to the issuance of the Vogel ‘595 and Vogel ‘776 patent, or
Appellants might have made the showing that the delays in prosecution were
due to USPTO action and deserving of the two-way test. We do not think
Appellants should be rewarded for dilatory filing of claims by eliminating
the common ownership element of double patenting found in the patent
rules.
We affirm the rejection of claim 1 under the judicially created
doctrine of obviousness type double patenting. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejections of claims 3-7, 10, 11,
16, and 21-25 as these claims were not argued separately.
CONCLUSION
In summary, we affirm the rejection of claim 1 the judicially created
doctrine of obviousness type double patenting. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejections of claims 3-7, 10, 11,
16, and 21-25 as these claims were not argued separately.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

dm

Trask Britt
P.O. Box 2550
Salt Lake City, UT 84110
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