Logical chasm defeats obviousness in St. Jude v. Access Closure
There was a mixed result in the St. Jude case:
ACI appeals three of the district court’s rulings: (1) that the safe-harbor provision of 35 U.S.C. § 121 protects the Janzen patent from invalidity due to double- patenting; (2) the construction of key terms in the Janzen patent; and (3) that ACI was not entitled to JMOL that the Fowler patents are invalid for obviousness. For the reasons that follow, we (1) reverse the district court’s safe harbor ruling regarding the Janzen patent; (2) in light of our safe harbor ruling, determine that the district court’s rulings regarding the claim constructions in the Janzen patent are moot; and (3) affirm the district court’s ruling that the Fowler patents are nonobvious and not shown to be invalid.
As to the safe harbor provision
We first address the district court’s application of the
safe harbor provision to the Janzen patent. The safe
harbor provision arose from difficulties created by restriction
requirements imposed by the U.S. Patent and
Trademark Office (PTO) during examination, followed by
double patenting challenges in the courts. A restriction
requirement arises during examination at the PTO when
an applicant pursues what are determined to be multiple
patentably distinct inventions in the same application (see
35 U.S.C. § 121). Subsequently, a double patenting
challenge may arise when, in an infringement suit, the
patentee is charged with having pursued the same or
obviously similar inventions in multiple applications, one
or more of which later issued as the patent in suit (see In
re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985)). A successful
double patenting defense invalidates the offending claims
in the patent. (...)
ACI contends that the Janzen patent violates consonance.
The judicially-created consonance concept derives
from the safe harbor’s “as a result of” requirement and
specifies that the “line of demarcation between the ‘independent
and distinct inventions’ that prompted the restriction
requirement be maintained.” Gerber Garment
Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir.
1990). An applicant’s pursuit of two or more non-elected
inventions in the same subsequent application does not by
itself violate the line of demarcation. See Boehringer
Ingelheim Int’l GmbH v. Barr Labs, Inc., 592 F.3d 1340,
1350 (Fed. Cir. 2010) (“The safe harbor is provided to
protect an applicant from losing rights when an application
is divided. The safe harbor of § 121 is not lost if an
applicant does not file separate divisional applications for
every invention or when independent and distinct inventions
are prosecuted together.”). However, in Gerber, we
concluded that “[p]lain common sense dictates that a
divisional application filed as a result of a restriction
requirement may not contain claims drawn to the invention
set forth in the claims elected and prosecuted to
patent in the parent application.” Gerber, 916 F.2d
at 687.
The requirement for consonance applies to both the
patent challenged for double patenting (the challenged
patent) and the patent being used as a reference against
the challenged patent (the reference patent). Boehringer,
592 F.3d at 1352 (“We have repeatedly held that the ‘as a
result of’ requirement applies to the challenged patent as
well as the reference patent.”). Consonance in a case like
this requires that the challenged patent, the reference
patent, and the patent in which the restriction requirement
was imposed (the restricted patent) do not claim any
of the same inventions identified by the examiner. (...)
The parties’ dispute turns in large measure on the nature
and effect of the examiner-imposed election of species.
An election of species is similar to a restriction and
again is explained best by example. An applicant may file
an application containing claims to a generic invention,
such as a widget. The application may also include claims
to several patentably distinct species of the generic invention,
such as the widget + X, the widget + Y, and the
widget + Z.
After reviewing the application, the examiner may
impose an election of species that requires the applicant
to choose one of the species for examination. The election
of species, like a typical restriction, helps the examiner to
focus the examination process. The applicant typically
elects a species (e.g., widget + X), focuses on prosecuting
the generic claims to the widget and any claims to the
widget + X species, and withdraws the claims to the nonelected
species, widget + Y and widget + Z. If the generic
claim to the widget is allowed, the applicant may obtain
claim coverage on all of the species. If the generic claim is
not allowed, the application is restricted.
The PTO regulation that formally sets forth the
framework for an election of species is 37 C.F.R. § 1.146:
In the first action on an application containing a
generic claim to a generic invention (genus) and
claims to more than one patentably distinct species
embraced thereby, the examiner may require
the applicant in the reply to that action to elect a
species of his or her invention to which his or her
claim will be restricted if no claim to the genus is
found to be allowable.
Thus, § 1.146 states that if no generic claim is found
allowable, then the election of species will create a restriction
under 35 U.S.C. § 121. 37 C.F.R. § 1.146 (“his or
her claim will be restricted if no claim to the genus is
found to be allowable”) (emphasis added).5
Returning to the parties’ arguments, ACI agrees that
the method/device restriction in the grandparent application
affected the line of demarcation, but argues that the
election of species did not affect the line because an election
of species is inherently different from a restriction
requirement.
St. Jude loses on consonance:
However, turning to the sibling patent, we conclude
that consonance was not maintained. The sibling patent’s
independent claim 1 is drawn to a method of sealing a
puncture in a wall of a blood vessel involving neither a
guidewire nor a dilator (i.e., a claim directed to Group II,
but not limited to any of Species A, B, or C). Thus the
sibling application was not filed “as a result” of the restriction
since it pursued a claim generic to all of the
Species in Group II, and therefore overlapped Group II,
Species C found in the Janzen patent.
The jury found that claims 7, 8, and 9 of the Janzen
patent are not patentably distinct from claims of the
sibling patent. The trial court saved invalidity under this
finding based on double patenting rules by applying the
safe harbor provision. Since we conclude that the Janzen
patent and the sibling patent did not maintain consonance,
and therefore the safe harbor provision cannot
apply, we hold that claims 7, 8, and 9 of the Janzen patent
are invalid. The trial court’s ruling to the contrary is
reversed.
As to obviousness:
In response, St. Jude contends that both prior art references
fail to disclose the Fowler patent’s claimed feature
of a balloon configured to operate as a positioning device
to prevent a plug from entering a blood vessel. In particular,
St. Jude argues that the references lack “an elongate
positioning member . . . to position said vessel plug . . .
without extending into the blood vessel” from claim 21 of
the ’375 patent and “inflating a member on an insertion
member to identify the location of the blood vessel adjacent
to the incision” and “positioning the vessel plug in
the incision such that the distal end of the vessel plug is
located proximally of the blood vessel” from the combination
of independent claim 9 and its dependent claim 14 of
the ’616 patent.
We review the jury’s conclusions on obviousness without
deference and the underlying findings of fact for
substantial evidence. The Johns Hopkins Univ. v. Datascope
Corp., 543 F.3d 1342, 1345 (Fed. Cir. 2008).
(...)
One of ordinary skill in the art at the
time of the invention would have viewed the balloon and
the gelfoam stick as substitutes to achieve the same
hemostasis objective, not as complementary devices to
achieve the positioning benefit of St. Jude’s claimed
invention. (...)
Therefore, while Takayasu does disclose using x-ray
and ultrasound to help place a gelfoam stick, between this
disclosure and the claimed invention lies a logical
chasm—a chasm not bridged by the prior art, common
sense, or ACI’s statements that the claimed invention was
obvious. Even under our “expansive and flexible” obviousness
analysis (see KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 415, (2007)), we must guard against “hindsight
bias” and “ex post reasoning” (id. at 421). Doing so here
compels us to reject ACI’s argument. (...)
ACI further contends that, because St. Jude’s expert
Dr. Kovacs allegedly provided only conclusory testimony,
the district court erred by rejecting ACI’s proposed combination.
Dr. Kovacs testified that the proposed combination
of Takayasu and Smiley was “very, very far out and it
makes no sense to me whatsoever” and “[c]ombining two
references which are independently farfetched is
farfetched times farfetched, it’s farfetched squared.” J.A.
10634–35.
Even if Dr. Kovacs provided conclusory testimony,
ACI did not carry its burden of proving invalidity. We
have held that “[s]ince we must presume a patent valid,
the patent challenger bears the burden of proving the
factual elements of invalidity by clear and convincing
evidence.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359
(Fed. Cir. 2007). This burden of proof never shifts to the
patentee. Id. ACI failed to carry its burden of proof.
Therefore, ACI’s arguments about Dr. Kovacs are immaterial.
We find each of ACI’s obviousness arguments without
merit and affirm the district court’s refusal to grant ACI’s
renewed motion for JMOL.
Irell & Manella, LLP for St. Jude; Knobbe, Martens Olson & Bear, LLP for Access Closure.
ACI appeals three of the district court’s rulings: (1) that the safe-harbor provision of 35 U.S.C. § 121 protects the Janzen patent from invalidity due to double- patenting; (2) the construction of key terms in the Janzen patent; and (3) that ACI was not entitled to JMOL that the Fowler patents are invalid for obviousness. For the reasons that follow, we (1) reverse the district court’s safe harbor ruling regarding the Janzen patent; (2) in light of our safe harbor ruling, determine that the district court’s rulings regarding the claim constructions in the Janzen patent are moot; and (3) affirm the district court’s ruling that the Fowler patents are nonobvious and not shown to be invalid.
As to the safe harbor provision
We first address the district court’s application of the
safe harbor provision to the Janzen patent. The safe
harbor provision arose from difficulties created by restriction
requirements imposed by the U.S. Patent and
Trademark Office (PTO) during examination, followed by
double patenting challenges in the courts. A restriction
requirement arises during examination at the PTO when
an applicant pursues what are determined to be multiple
patentably distinct inventions in the same application (see
35 U.S.C. § 121). Subsequently, a double patenting
challenge may arise when, in an infringement suit, the
patentee is charged with having pursued the same or
obviously similar inventions in multiple applications, one
or more of which later issued as the patent in suit (see In
re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985)). A successful
double patenting defense invalidates the offending claims
in the patent. (...)
ACI contends that the Janzen patent violates consonance.
The judicially-created consonance concept derives
from the safe harbor’s “as a result of” requirement and
specifies that the “line of demarcation between the ‘independent
and distinct inventions’ that prompted the restriction
requirement be maintained.” Gerber Garment
Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir.
1990). An applicant’s pursuit of two or more non-elected
inventions in the same subsequent application does not by
itself violate the line of demarcation. See Boehringer
Ingelheim Int’l GmbH v. Barr Labs, Inc., 592 F.3d 1340,
1350 (Fed. Cir. 2010) (“The safe harbor is provided to
protect an applicant from losing rights when an application
is divided. The safe harbor of § 121 is not lost if an
applicant does not file separate divisional applications for
every invention or when independent and distinct inventions
are prosecuted together.”). However, in Gerber, we
concluded that “[p]lain common sense dictates that a
divisional application filed as a result of a restriction
requirement may not contain claims drawn to the invention
set forth in the claims elected and prosecuted to
patent in the parent application.” Gerber, 916 F.2d
at 687.
The requirement for consonance applies to both the
patent challenged for double patenting (the challenged
patent) and the patent being used as a reference against
the challenged patent (the reference patent). Boehringer,
592 F.3d at 1352 (“We have repeatedly held that the ‘as a
result of’ requirement applies to the challenged patent as
well as the reference patent.”). Consonance in a case like
this requires that the challenged patent, the reference
patent, and the patent in which the restriction requirement
was imposed (the restricted patent) do not claim any
of the same inventions identified by the examiner. (...)
The parties’ dispute turns in large measure on the nature
and effect of the examiner-imposed election of species.
An election of species is similar to a restriction and
again is explained best by example. An applicant may file
an application containing claims to a generic invention,
such as a widget. The application may also include claims
to several patentably distinct species of the generic invention,
such as the widget + X, the widget + Y, and the
widget + Z.
After reviewing the application, the examiner may
impose an election of species that requires the applicant
to choose one of the species for examination. The election
of species, like a typical restriction, helps the examiner to
focus the examination process. The applicant typically
elects a species (e.g., widget + X), focuses on prosecuting
the generic claims to the widget and any claims to the
widget + X species, and withdraws the claims to the nonelected
species, widget + Y and widget + Z. If the generic
claim to the widget is allowed, the applicant may obtain
claim coverage on all of the species. If the generic claim is
not allowed, the application is restricted.
The PTO regulation that formally sets forth the
framework for an election of species is 37 C.F.R. § 1.146:
In the first action on an application containing a
generic claim to a generic invention (genus) and
claims to more than one patentably distinct species
embraced thereby, the examiner may require
the applicant in the reply to that action to elect a
species of his or her invention to which his or her
claim will be restricted if no claim to the genus is
found to be allowable.
Thus, § 1.146 states that if no generic claim is found
allowable, then the election of species will create a restriction
under 35 U.S.C. § 121. 37 C.F.R. § 1.146 (“his or
her claim will be restricted if no claim to the genus is
found to be allowable”) (emphasis added).5
Returning to the parties’ arguments, ACI agrees that
the method/device restriction in the grandparent application
affected the line of demarcation, but argues that the
election of species did not affect the line because an election
of species is inherently different from a restriction
requirement.
St. Jude loses on consonance:
However, turning to the sibling patent, we conclude
that consonance was not maintained. The sibling patent’s
independent claim 1 is drawn to a method of sealing a
puncture in a wall of a blood vessel involving neither a
guidewire nor a dilator (i.e., a claim directed to Group II,
but not limited to any of Species A, B, or C). Thus the
sibling application was not filed “as a result” of the restriction
since it pursued a claim generic to all of the
Species in Group II, and therefore overlapped Group II,
Species C found in the Janzen patent.
The jury found that claims 7, 8, and 9 of the Janzen
patent are not patentably distinct from claims of the
sibling patent. The trial court saved invalidity under this
finding based on double patenting rules by applying the
safe harbor provision. Since we conclude that the Janzen
patent and the sibling patent did not maintain consonance,
and therefore the safe harbor provision cannot
apply, we hold that claims 7, 8, and 9 of the Janzen patent
are invalid. The trial court’s ruling to the contrary is
reversed.
As to obviousness:
In response, St. Jude contends that both prior art references
fail to disclose the Fowler patent’s claimed feature
of a balloon configured to operate as a positioning device
to prevent a plug from entering a blood vessel. In particular,
St. Jude argues that the references lack “an elongate
positioning member . . . to position said vessel plug . . .
without extending into the blood vessel” from claim 21 of
the ’375 patent and “inflating a member on an insertion
member to identify the location of the blood vessel adjacent
to the incision” and “positioning the vessel plug in
the incision such that the distal end of the vessel plug is
located proximally of the blood vessel” from the combination
of independent claim 9 and its dependent claim 14 of
the ’616 patent.
We review the jury’s conclusions on obviousness without
deference and the underlying findings of fact for
substantial evidence. The Johns Hopkins Univ. v. Datascope
Corp., 543 F.3d 1342, 1345 (Fed. Cir. 2008).
(...)
One of ordinary skill in the art at the
time of the invention would have viewed the balloon and
the gelfoam stick as substitutes to achieve the same
hemostasis objective, not as complementary devices to
achieve the positioning benefit of St. Jude’s claimed
invention. (...)
Therefore, while Takayasu does disclose using x-ray
and ultrasound to help place a gelfoam stick, between this
disclosure and the claimed invention lies a logical
chasm—a chasm not bridged by the prior art, common
sense, or ACI’s statements that the claimed invention was
obvious. Even under our “expansive and flexible” obviousness
analysis (see KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 415, (2007)), we must guard against “hindsight
bias” and “ex post reasoning” (id. at 421). Doing so here
compels us to reject ACI’s argument. (...)
ACI further contends that, because St. Jude’s expert
Dr. Kovacs allegedly provided only conclusory testimony,
the district court erred by rejecting ACI’s proposed combination.
Dr. Kovacs testified that the proposed combination
of Takayasu and Smiley was “very, very far out and it
makes no sense to me whatsoever” and “[c]ombining two
references which are independently farfetched is
farfetched times farfetched, it’s farfetched squared.” J.A.
10634–35.
Even if Dr. Kovacs provided conclusory testimony,
ACI did not carry its burden of proving invalidity. We
have held that “[s]ince we must presume a patent valid,
the patent challenger bears the burden of proving the
factual elements of invalidity by clear and convincing
evidence.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359
(Fed. Cir. 2007). This burden of proof never shifts to the
patentee. Id. ACI failed to carry its burden of proof.
Therefore, ACI’s arguments about Dr. Kovacs are immaterial.
We find each of ACI’s obviousness arguments without
merit and affirm the district court’s refusal to grant ACI’s
renewed motion for JMOL.
Irell & Manella, LLP for St. Jude; Knobbe, Martens Olson & Bear, LLP for Access Closure.
posted by Lawrence B. Ebert at 7:17 AM
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