Ex Parte Simard et al

Patent Trial and Appeal Board

Feb 13, 2019

11574793 (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/574,793 10/30/2008
26271 7590 02/15/2019
NORTON ROSE FULBRIGHT US LLP
1301 MCKINNEY
SUITE 5100
HOUSTON, TX 77010-3095
FIRST NAMED INVENTOR
J. Marc Simard
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
HO-P03017US3 9484
EXAMINER
HOWARD, ZACHARY C
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
02/15/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
hoipdocket@nortonrosefulbright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte J. MARC SIMARD and MINGKUI CHEN
Appeal2017-007262
Application 11/574,793 1
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating acute cerebral ischemia, or reducing edema in a peri-infarct tissue
area, or reducing mortality of a subject suffering from a stroke, which have
been rejected as being unpatentable on the ground of nonstatutory double
patenting. Oral Argument was held February 5, 2019. We have jurisdiction
under 35 U.S.C. § 6(b ).
We reverse.
1 Appellants identify the real party in interest as University of Maryland,
Baltimore and the United States of America as represented by the
Department of Veterans Affairs. (Appeal Br. 3.)
Appeal2017-007262
Application 11/574,793
STATEMENT OF THE CASE
"[T]he gliotic capsule represents the response of the brain to an
injurious stimulus -- an attempt by the brain to wall off, isolate, dispose of,
and otherwise protect itself from the foreign body." (Spec. ,r 8.) "Despite
the overall benefits, the gliotic capsule forms a potentially harmful mass of
tissue that contributes to brain swelling and mass effect, and that may shelter
foreign cells from surveillance by the immune system." (Id. f 11.)
"[R ]eactive astrocytes (RI astrocytes) in the inner zone of the gliotic capsule
express a novel [ sulfonylurea receptor type 1] SURI-regulated cation
channel, the NCca-ATP channel, and ... this channel directly controls cell
viability: opening the channel is associated with necrotic cell death and
closing the channel is associated with protection from cell death induced by
energy (ATP) depletion." (Id.) "[T]he present invention relates to the
regulation and/or modulation of this NCca-ATP channel and its role in
maintaining or disrupting the integrity of the gliotic capsule." (Id. ,r 18.)
Claims 39, 40, 42-51, 53-55, 57-60, 66, 68, 72, 108, 111, and 114 are
on appeal. Claim 39 is representative and reads as follows:
39. A method of treating acute cerebral ischemia in a subject
comprising administering to the subject an effective amount of
tissue plasminogen activator ( tP A) and also administering an
effective amount of a compound or a pharmaceutically
acceptable salt thereof, said compound or pharmaceutically
acceptable salt thereof being effective to inhibit a non-selective
monovalent cationic ATP-sensitive (NCca-ATP) channel and to:
a) increase the therapeutic window for the administration
oftPA, or
b) reduce hemorrhagic conversion, cell swelling, or
edema, or
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Appeal2017-007262
Application 11/574,793
c) both a) and b ), wherein the compound is a
sulfonylurea compound, a benzamido derivative, L Y397364,
L Y389382, or an estrogen-related compound.
(Appeal Br. 12.)
The following ground of rejection by the Examiner is before us on
review2 :
Claims 39, 40, 42-51, 53-55, 57---60, 66, 68, 72, 108, 111, and 114 on
the ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 1-32 of U.S. Patent No. 8,980,952.
DISCUSSION
The Examiner finds that the independent claims of the '952 patent
"encompass" a method "comprising administering glibenclamide." (Non-
Final Action 3 3.) The Examiner explains that the administration is for a
variety of purposes including "ameliorating the effect of a reduction in blood
flow in peri-infarct brain tissue in ischemic disease or injury in a subject
( claim 1 ), . . . alleviating brain swelling in a subject ( claim 16), treating
acute cerebral ischemia in a subject (claims 19 and 32), and alleviating one
or more effects of traumatic brain injury or cerebral ischemia in a subject
(claims 28, 30 and 32)." (Id.) The Examiner further finds "the specification
of the '952 patent informing the claimed invention teaches co-administration
with a thrombolytic agent, including t-PA." (Id. at 3--4.)
2 The Examiner made a second provisional rejection for obviousness-type
double patenting over Application 14/634,855. That application, however,
has since been abandoned. Therefore, the rejection has been mooted.
3 The Non-Final action is dated February 18, 2016.
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Appeal2017-007262
Application 11/574,793
The Examiner states that
The use of the transitional phrase "comprising" indicates that
the scope of the claims encompasses administration of elements
in addition to glibenclamide.
(Id. at 4--5.) The Examiner turns to the '952 specification and notes that it
"teaches that these additional elements include a thrombolytic agent,
including tPA." (Id. at 5.) In light of this, the Examiner states that "[t]he
disclosure of the '952 patent is such that it could have provided support for
dependent claims ( depending from claim 1 of '952) wherein tP A is
administered in addition to glibenclamide." (Ans. 6; see also Non-Final
Action 5.) The Examiner, therefore, contends that it is proper to construe
"the scope of the reference claims ('952 patent) ... to encompass
administration of glibenclamide and a thrombolytic agent, including tP A."
(Final Action 5.) Consequently, the Examiner concludes that "the claimed
method of the '952 patent anticipates the instant claims" and thus the instant
claims are not patentably distinct from claims 1-32 of the '952 patent.
(Non-Final Action 4; see also Ans. 2, 6.)
We find that the Examiner has erroneously used Appellants'
specification as prior art against them in coming to the conclusion that the
claims on appeal, while not identical to the '952 patent claims, are
"anticipated" by the '952 patent claims, and thus, are not patentably distinct.
Indeed, the Examiner's analysis makes it quite clear that under the guise of
"constru[ing the claimed method of the '952 patent] in view of the
disclosure" (Ans. 4), the Examiner has improperly imported from the '952
specification into the claims of the '952 patent the limitation of
administering tP A.
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Appeal2017-007262
Application 11/574,793
While it is true that both sets of claims are directed to administering
glibenclamide, a sulfonylurea compound, the claims on appeal require that
tPA is also administered. The '952 patent claims, on the other hand, do not
require administration of tP A. It is true, and Appellants do not contest, that
the '952 patent claims "allow[] for one, two, or even dozens of additional
active ingredients" including tP A by the use of the open ended transition
term "comprising." (Reply Br. 5.) However, as Appellants point out, the
fact that the '952 patent claims dominate the claims on appeal because they
encompass those claims, does not by itself support a double patenting
rejection. (Id.; see MPEP § 804 II ("One patent or application 'dominates' a
second patent or application when the first patent or application has a broad
or generic claim which fully encompasses or reads on an invention defined
in a narrower or more specific claim in another patent or application.
Domination by itself, i.e., in the absence of statutory or nonstatutory double
patenting grounds, cannot support a double patenting rejection. In re
Kaplan, 789 F.2d 1574, 1577-78 (Fed. Cir. 1986); In re Sarett, 327 F.2d
1005, 1014--15 (CCPA 1964).").)
We disagree with the Examiner that construction of the term
"comprising" allows importation of a method step of adding tP A to the '952
patent claims such that the claims of that patent are considered to recite that
step. "In the patent claim context, the term 'comprising' is well understood
to mean 'including but not limited to'." CIAS, Inc. v. Alliance Gaming
Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007). In other words, the use of that
term in the '952 patent claims "means that the named elements are essential,
but other elements may be added and still form a construct within the scope
of the claim." Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir.
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Application 11/574,793
1997). It does not mean that the claim itself recites any specific additional
elements. That is so regardless of what additional steps the specification of
that patent may disclose. Thus, while the claims in the application being
examined overlap in scope with claims of the '952 patent in that both sets of
claims require the administration of glibenclamide, the potentially
conflicting claims of the patent cannot be said to "anticipate" the examined
claims for the reason the Examiner set forth.
As Appellants recognize (Reply Br. 5), the '952 patent claims can be
considered a genus of methods where, at a minimum, what is required is the
administration of glibenclamide. One can, therefore, question whether on
reading the potentially conflicting patent or application, one could at once
envisage the invention claimed in the examined application. (See MPEP
§ 804 II citing Abb Vie Inc. v. Kennedy Institute of Rheumatology Trust, 7 64
F.3d 1366 (Fed. Cir. 2014).)
As Appellants note, "one cannot 'at once envisage' the species recited
in the '793 application claims. (Id.) "It is well established that the
disclosure of a genus in the prior art[, e.g., the '952 patent claims, here,] is
not necessarily a disclosure of every species that is a member of that genus."
Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). It
is only when the genus is so limited that a person of ordinary skill in the art
can "at once envisage each member of a limited class" that "a reference
describing the genus anticipates every species within the genus." In re
Gleave, 560 F.3d 1331, 1338 (Fed. Cir. 2009). There is no such "limited
class" of additional components that can be added as a step in the claimed
method of the '952 patent claims. The '952 patent claims do recite adding
glucose, but that is not a thrombolytic agent. (Appeal Br. 8.)
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Application 11/574,793
The fact that there is overlap between the two sets of claims, in that
both recite the administration of glibenclamide as the compound effective to
inhibit a non-selective monovalent cationic ATP-sensitive (NCca-ATP)
channel, is not dispositive of whether the additional requirements of the
claims on appeal, i.e., administration of tP A as well, is a patentably
indistinct variant of the reference patent claims. In a case such as this one,
where the claim in the application being examined overlaps in scope with a
claim in a potentially conflicting patent, and one cannot at once envisage
each member of a limited class, the Examiner is required to analyze the
claims of the application for obviousness. Here, the Examiner has failed to
identify the missing elements from the reference patent as being in the prior
art. Instead, the Examiner simply notes that Appellants' Specification
discloses co-administration of tP A in treatment methods that also administer
a compound that inhibits the NCca-ATP channel. (Ans. 3.) We note, as
Appellants do, that the portion of the '952 Specification that the Examiner
relies on also describes co-administration with "antiplatelets, anti-
coagulants, vasodilators, statins, and diuretics ( col. 30, lines 8-11 ); blockers
of KATP channel (col. 35, line 60-67); transcription factors that modulate
SURI expression (col. 35, lines 34--47); and antisense molecules (col. 35,
line 65---col. 36, line 6)." (Reply Br. 6.) But, such disclosure in the '952
Specification, does not establish that co-administration of any one of these
additional compounds is taught by the '952 patent claims as prior art. And,
the Examiner has not provided any other reasons supporting the obviousness
based on prior art of the step of administering tP A in conjunction with a
compound that inhibits the NCca-ATP channel.
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Application 11/574,793
Thus, we do not sustain the Examiner's obviousness-double patenting
rejection.
SUMMARY
We reverse the rejection of claims 39, 40, 42-51, 53-55, 57---60, 66,
68, 72, 108, 111, and 114 on the ground of non-statutory obviousness-type
double patenting as being unpatentable over claims 1-32 of U.S. Patent No.
8,980,952.
REVERSED
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