CAFC in In re Hubbell
The "Hubbell" in In re Hubbell is Jeffrey Hubbell, who was a Professor of Chemical
Engineering at California Institute of Technology, who is a named inventor on U.S. Patent Application
No. 10/650,509 (“the ’509 application”). Claims of the '509 were rejected for for obviousness-type double
patenting over several patents, including U.S. Patent No. 7,601,685 (“the ’685 patent”), for which Hubbell was an inventor
but which patent was not owned by CalTech. With the panel majority adopting MPEP 804, the Hubbell case
illustrates an interesting trap for the unwary, wherein common inventors alone create a window for obviousness-type
double-patenting rejections, which CANNOT be cured by a terminal disclaimer when different owners are involved.
The ’509 application, entitled “Enzyme-Mediated Modification
of Fibrin for Tissue Engineering,” was filed on
August 27, 2003, but claims priority to U.S. Provisional Application Serial No.
60/042,143, filed April 3, 1997. All of
the named inventors on the '509 application were affiliated with CalTech, and the
’509 application is assigned to CalTech.
The twist is this: Hubbell left CalTech and joined the faculty at Eidgenossische
Technische Hochschule Zurich (“ETHZ”) in
1998 – roughly five years before the ’509 application was
filed. The application that issued as the ’685 patent was
filed on December 17, 2002, and is based on research
Hubbell and Schense conducted at ETHZ. Claim 1 of the ’685 patent recites:
A fusion protein, comprising (...) and Hubbell is a named inventor.
The legal issue turns on: It is undisputed that, although the ’509 application
and the ’685 patent have two inventors in common –
Hubbell and Schense – they do not have identical inventive
entities and have neither common owners nor
common assignees. But, MPEP 804 does not require identical
inventive entities.
Further relevant details come from the history of the '509:
The ’509 application is a continuation of Application
No. 10/024,918 (now abandoned), filed on December
18, 2001, which is a continuation-in-part of Application
No. 09/057,052, filed April 8, 1998, now U.S. Patent No.
6,331,422, which is a continuation of International Application
No. PCT/US98/06617, filed April 2, 1998, which
claims priority to U.S. Provisional Application Serial No.
60/042,143, filed April 3, 1997.
The CAFC noted: During prosecution of the ’918 application, the
examiner rejected all of the pending claims based on
obviousness-type double patenting over U.S. Patent No. 6,331,422 (“the ’422 patent”) and Application No.
09/695,466, which issued as U.S. Patent No. 6,607,740
(“the ’740 patent”) on August 19, 2003. Hubbell and
Schense are the named inventors on the ’422 and ’740
patents, and both patents were assigned to CalTech.(...) Although the
examiner issued a Notice of Allowance [for the '918] in June 2003,
Hubbell failed to pay the issue fee within the statutory
period, let the ’918 application go abandoned, and instead
filed the ’509 application on August 27, 2003.
AND
In a final Office Action [for the '509] dated October 5, 2007, the examiner
rejected claims 1-5, 7, 9-14, 16-22, 26-30, 34, and
35 of the ’509 application for obviousness-type double
patenting over the ’422 and ’740 patents, the application
that issued as U.S. Patent No. 7,247,609 (“the ’609 patent”)
to Lutolf, et al., and the application that issued as
the ’685 patent (Application No. 10/323,046). In relevant
part, the examiner found that the conflicting claims in the
’685 patent “are a species of the instantly claimed invention
and as such are encompassed by the claimed invention
and thus anticipate the claimed invention.” Board
Decision, 2011 Pat. App. LEXIS 19847, at *11. Hubbell
appealed the rejections to the Board.
As to the specifics of the issue:
Turning to the examiner’s rejection for obviousness type
double patenting over certain claims in the ’685
patent, the Board agreed with the examiner that the
claims of the ’685 patent anticipate representative claim
18. Specifically, the Board found that claim 1 of the ’685
patent recites a protein that contains both of the features
required in rejected claim 18: “a transglutaminase substrate
domain (the crosslinking Factor XIIIa substrate
domain) and a domain encoding a growth factor.” Board
Decision, 2011 Pat. App. LEXIS 19847, at *13. The Board
also noted that claim 18’s use of the term “comprising”
allowed for inclusion of the additional elements recited in
claim 1 of the ’685 patent, including an enzymatic cleavage
site not otherwise recited in claim 18. Accordingly,
the Board found the obviousness-type double patenting
rejection proper because the genus claim in the ’509
application was anticipated by issued claims directed to a
species falling within that genus.
So, the later-filed claim 1 of the '685 patent
was a species which anticipated the earlier-filed genus claim of the '509
application. Obviousness-type double patenting existed according to the Board
which: began its analysis by citing the
Manual of Patent Examining Procedure (“MPEP”), which
provides 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.”
MPEP § 804(I)(A) (emphasis added).
The CAFC began its legal analysis:
Obviousness-type double patenting is a judicially created
doctrine designed to “prevent claims in separate
applications or patents that do not recite the ‘same’ invention,
but nonetheless claim inventions so alike that granting
both exclusive rights would effectively extend the life
of patent protection.” Perricone v. Medicis Pharm. Corp.,
432 F.3d 1368, 1373 (Fed. Cir. 2005) (citation omitted). It
prohibits the issuance of claims in a second patent that
are “not patentably distinct from the claims of the first
patent.” In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985)
(citations omitted). A later patent claim “is not patentably
distinct from an earlier claim if the later claim is
obvious over, or anticipated by, the earlier claim.” Eli
Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed.
Cir. 2001) (citations omitted). In passing, IPBiz notes the
CAFC cites to In re Emert,124 F.3d 1458, 1460 (Fed. Cir. 1997), a case
in which Exxon fared badly.
Hubbell got no traction arguing against the presence of obviousness-type
double-patenting. Here, the panel majority adopted the text of MPEP 804
[note: Although the MPEP is not binding on
this court, we can take judicial notice of this provision to
the extent it does not conflict with statutory text. Enzo
Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed.
Cir. 2002) (stating that the PTO Guidelines governing its
internal practice and the MPEP “are not binding on this
court, but may be given judicial notice to the extent they
do not conflict with the statute”). ] Thus, the presence of a "common inventor"
opened up the gates for an obviousness-type double patenting rejection.
Hubbell's other arguments were of interest:
In the alternative, if the court
finds that an obviousness-type double patenting rejection
is applicable, Hubbell argues that either he should be
allowed to file a terminal disclaimer as an equitable
measure or that this court should employ a two-way
obviousness analysis for the rejected claims.
An interesting sub-theme of waiver appears in footnote 3:
The Director also argues that Hubbell waived his
terminal disclaimer and two-way obviousness analysis
arguments by failing to raise them before the Board.
The CAFC did reach these points, though.
Also, of the obviousness-type text in the MPEP, the CAFC noted:
Although the MPEP is not binding on
this court, we can take judicial notice of this provision to
the extent it does not conflict with statutory text. Enzo
Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed.
Cir. 2002) (stating that the PTO Guidelines governing its
internal practice and the MPEP “are not binding on this
court, but may be given judicial notice to the extent they
do not conflict with the statute”).
As to the terminal disclaimer argument:
In the alternative, Hubbell argues that, if obviousness-
type double patenting does apply, we should authorize
him to file a terminal disclaimer and thus avoid any
concern regarding undue extension of the rights granted
in the ’685 patent. As a general rule, a terminal disclaimer
filed to overcome an obviousness-type double patenting
rejection is effective only where the application and
conflicting patent are commonly owned. See Fallaux, 564
F.3d at 1319 (“If the Fallaux application and the Vogels
patents were commonly owned, the terminal disclaimer
filed in this case would have been effective to overcome
the double patenting rejection.”).
The CAFC noted --37 CFR § 1.321(c)(3) specifically provides that a terminal disclaimer
“filed to obviate judicially created double patenting
in a patent application” must include “a provision that
any patent granted on that application . . . shall be enforceable
only for and during such period that said patent
is commonly owned with the application or patent which
formed the basis for the judicially created double patenting.”
37 C.F.R. § 1.321(c)(3) (emphasis added).--
An important point about patent strategy appears in footnote 6:
During oral argument, counsel for Hubbell explained
that CalTech – the assignee of the ’918 application
– intentionally let the claims go abandoned. See Oral
Argument at 26:30, available at
http://www.cafc.uscourts.gov/oral-argumentrecordings/
2011-1547/all (“The claims required recombinantly
producing the fusion protein . . . when the claims
were granted CalTech looked at those claims and said
‘you know what, we disclosed that it doesn’t have to be
limited to recombinantly producing it. Let’s refile it; we’ll
get it allowed quickly.’”).
Judge Newman strongly dissented:
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.
A weakness in her argument was citation to an out-of-date version of the MPEP:
MPEP §804 (4th ed. 1979).
And this omission infects the argument:
The panel majority does not dispute that these are different
inventive entities and that there is not common
ownership. However, the court rules that obviousnesstype
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.
Engineering at California Institute of Technology, who is a named inventor on U.S. Patent Application
No. 10/650,509 (“the ’509 application”). Claims of the '509 were rejected for for obviousness-type double
patenting over several patents, including U.S. Patent No. 7,601,685 (“the ’685 patent”), for which Hubbell was an inventor
but which patent was not owned by CalTech. With the panel majority adopting MPEP 804, the Hubbell case
illustrates an interesting trap for the unwary, wherein common inventors alone create a window for obviousness-type
double-patenting rejections, which CANNOT be cured by a terminal disclaimer when different owners are involved.
The ’509 application, entitled “Enzyme-Mediated Modification
of Fibrin for Tissue Engineering,” was filed on
August 27, 2003, but claims priority to U.S. Provisional Application Serial No.
60/042,143, filed April 3, 1997. All of
the named inventors on the '509 application were affiliated with CalTech, and the
’509 application is assigned to CalTech.
The twist is this: Hubbell left CalTech and joined the faculty at Eidgenossische
Technische Hochschule Zurich (“ETHZ”) in
1998 – roughly five years before the ’509 application was
filed. The application that issued as the ’685 patent was
filed on December 17, 2002, and is based on research
Hubbell and Schense conducted at ETHZ. Claim 1 of the ’685 patent recites:
A fusion protein, comprising (...) and Hubbell is a named inventor.
The legal issue turns on: It is undisputed that, although the ’509 application
and the ’685 patent have two inventors in common –
Hubbell and Schense – they do not have identical inventive
entities and have neither common owners nor
common assignees. But, MPEP 804 does not require identical
inventive entities.
Further relevant details come from the history of the '509:
The ’509 application is a continuation of Application
No. 10/024,918 (now abandoned), filed on December
18, 2001, which is a continuation-in-part of Application
No. 09/057,052, filed April 8, 1998, now U.S. Patent No.
6,331,422, which is a continuation of International Application
No. PCT/US98/06617, filed April 2, 1998, which
claims priority to U.S. Provisional Application Serial No.
60/042,143, filed April 3, 1997.
The CAFC noted: During prosecution of the ’918 application, the
examiner rejected all of the pending claims based on
obviousness-type double patenting over U.S. Patent No. 6,331,422 (“the ’422 patent”) and Application No.
09/695,466, which issued as U.S. Patent No. 6,607,740
(“the ’740 patent”) on August 19, 2003. Hubbell and
Schense are the named inventors on the ’422 and ’740
patents, and both patents were assigned to CalTech.(...) Although the
examiner issued a Notice of Allowance [for the '918] in June 2003,
Hubbell failed to pay the issue fee within the statutory
period, let the ’918 application go abandoned, and instead
filed the ’509 application on August 27, 2003.
AND
In a final Office Action [for the '509] dated October 5, 2007, the examiner
rejected claims 1-5, 7, 9-14, 16-22, 26-30, 34, and
35 of the ’509 application for obviousness-type double
patenting over the ’422 and ’740 patents, the application
that issued as U.S. Patent No. 7,247,609 (“the ’609 patent”)
to Lutolf, et al., and the application that issued as
the ’685 patent (Application No. 10/323,046). In relevant
part, the examiner found that the conflicting claims in the
’685 patent “are a species of the instantly claimed invention
and as such are encompassed by the claimed invention
and thus anticipate the claimed invention.” Board
Decision, 2011 Pat. App. LEXIS 19847, at *11. Hubbell
appealed the rejections to the Board.
As to the specifics of the issue:
Turning to the examiner’s rejection for obviousness type
double patenting over certain claims in the ’685
patent, the Board agreed with the examiner that the
claims of the ’685 patent anticipate representative claim
18. Specifically, the Board found that claim 1 of the ’685
patent recites a protein that contains both of the features
required in rejected claim 18: “a transglutaminase substrate
domain (the crosslinking Factor XIIIa substrate
domain) and a domain encoding a growth factor.” Board
Decision, 2011 Pat. App. LEXIS 19847, at *13. The Board
also noted that claim 18’s use of the term “comprising”
allowed for inclusion of the additional elements recited in
claim 1 of the ’685 patent, including an enzymatic cleavage
site not otherwise recited in claim 18. Accordingly,
the Board found the obviousness-type double patenting
rejection proper because the genus claim in the ’509
application was anticipated by issued claims directed to a
species falling within that genus.
So, the later-filed claim 1 of the '685 patent
was a species which anticipated the earlier-filed genus claim of the '509
application. Obviousness-type double patenting existed according to the Board
which: began its analysis by citing the
Manual of Patent Examining Procedure (“MPEP”), which
provides 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.”
MPEP § 804(I)(A) (emphasis added).
The CAFC began its legal analysis:
Obviousness-type double patenting is a judicially created
doctrine designed to “prevent claims in separate
applications or patents that do not recite the ‘same’ invention,
but nonetheless claim inventions so alike that granting
both exclusive rights would effectively extend the life
of patent protection.” Perricone v. Medicis Pharm. Corp.,
432 F.3d 1368, 1373 (Fed. Cir. 2005) (citation omitted). It
prohibits the issuance of claims in a second patent that
are “not patentably distinct from the claims of the first
patent.” In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985)
(citations omitted). A later patent claim “is not patentably
distinct from an earlier claim if the later claim is
obvious over, or anticipated by, the earlier claim.” Eli
Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed.
Cir. 2001) (citations omitted). In passing, IPBiz notes the
CAFC cites to In re Emert,124 F.3d 1458, 1460 (Fed. Cir. 1997), a case
in which Exxon fared badly.
Hubbell got no traction arguing against the presence of obviousness-type
double-patenting. Here, the panel majority adopted the text of MPEP 804
[note: Although the MPEP is not binding on
this court, we can take judicial notice of this provision to
the extent it does not conflict with statutory text. Enzo
Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed.
Cir. 2002) (stating that the PTO Guidelines governing its
internal practice and the MPEP “are not binding on this
court, but may be given judicial notice to the extent they
do not conflict with the statute”). ] Thus, the presence of a "common inventor"
opened up the gates for an obviousness-type double patenting rejection.
Hubbell's other arguments were of interest:
In the alternative, if the court
finds that an obviousness-type double patenting rejection
is applicable, Hubbell argues that either he should be
allowed to file a terminal disclaimer as an equitable
measure or that this court should employ a two-way
obviousness analysis for the rejected claims.
An interesting sub-theme of waiver appears in footnote 3:
The Director also argues that Hubbell waived his
terminal disclaimer and two-way obviousness analysis
arguments by failing to raise them before the Board.
The CAFC did reach these points, though.
Also, of the obviousness-type text in the MPEP, the CAFC noted:
Although the MPEP is not binding on
this court, we can take judicial notice of this provision to
the extent it does not conflict with statutory text. Enzo
Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed.
Cir. 2002) (stating that the PTO Guidelines governing its
internal practice and the MPEP “are not binding on this
court, but may be given judicial notice to the extent they
do not conflict with the statute”).
As to the terminal disclaimer argument:
In the alternative, Hubbell argues that, if obviousness-
type double patenting does apply, we should authorize
him to file a terminal disclaimer and thus avoid any
concern regarding undue extension of the rights granted
in the ’685 patent. As a general rule, a terminal disclaimer
filed to overcome an obviousness-type double patenting
rejection is effective only where the application and
conflicting patent are commonly owned. See Fallaux, 564
F.3d at 1319 (“If the Fallaux application and the Vogels
patents were commonly owned, the terminal disclaimer
filed in this case would have been effective to overcome
the double patenting rejection.”).
The CAFC noted --37 CFR § 1.321(c)(3) specifically provides that a terminal disclaimer
“filed to obviate judicially created double patenting
in a patent application” must include “a provision that
any patent granted on that application . . . shall be enforceable
only for and during such period that said patent
is commonly owned with the application or patent which
formed the basis for the judicially created double patenting.”
37 C.F.R. § 1.321(c)(3) (emphasis added).--
An important point about patent strategy appears in footnote 6:
During oral argument, counsel for Hubbell explained
that CalTech – the assignee of the ’918 application
– intentionally let the claims go abandoned. See Oral
Argument at 26:30, available at
http://www.cafc.uscourts.gov/oral-argumentrecordings/
2011-1547/all (“The claims required recombinantly
producing the fusion protein . . . when the claims
were granted CalTech looked at those claims and said
‘you know what, we disclosed that it doesn’t have to be
limited to recombinantly producing it. Let’s refile it; we’ll
get it allowed quickly.’”).
Judge Newman strongly dissented:
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.
A weakness in her argument was citation to an out-of-date version of the MPEP:
MPEP §804 (4th ed. 1979).
And this omission infects the argument:
The panel majority does not dispute that these are different
inventive entities and that there is not common
ownership. However, the court rules that obviousnesstype
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.
posted by Lawrence B. Ebert at 11:58 PM
0 Comments:
Post a Comment
<< Home