Ex Parte Poulsen et al

Patent Trial and Appeal Board

Feb 14, 2018

12395665 (P.T.A.B. Feb. 14, 2018)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/395,665 02/28/2009 David J. Poulsen 15739.011 4806
54434 7590 02/16/2018
BOOTH UDALL FULLER, PLC
1255 W. Rio Salado Pkwy.
Suite 215
Tempe, AZ 85281
EXAMINER
RAMACHANDRAN, UMAMAHESWARI
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
02/16/2018 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):
PATENT@BOOTHUDALL.COM
reception @ boothudall .com
aho @boothudall. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID J. POULSEN and THOMAS FREDERICK1
Appeal 2016-008164
Application 12/395,665
Technology Center 1600
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of reducing brain cell death by administering
methamphetamine. Claims 1—26 are on appeal as rejected under 35 U.S.C.
§103 and for obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as “University of Montana.”
Appeal Br. 1.
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Application 12/395,665
STATEMENT OF THE CASE
The Specification states:
Strokes are the leading cause of disability among adults, with
over 80% involving ischemic insult. To date, no preventative or
neuroprotective therapy has proven to be efficacious in humans.
Amphetamines are one of the most extensively studied and
promising group of drugs used to facilitate stroke recovery after
neuronal cell damage has occurred (see (Martinsson and Eksborg
2004)). In rats, a single dose of amphetamines (e.g.,
dexamphetamine) administered 24 hrs after sensorimotor cortex
ablation promotes hemiplegic recovery (Feeney et al. 1982).
Spec. 1:23—29. The Specification further states, “[a] need still exists for an
effective treatment that reduces the occurrence of brain cell damage or death
after the occurrence of a transient cerebral hypoxic/ischemic condition or a
traumatic brain injury (TBI) event.” Id. at 2:17—19.
Claims 1 and 15 are independent claims. Claim 1 is representative:
1. A method of reducing brain cell death caused by transient
cerebral hypoxia and/or ischemia, the method comprising
identifying a subject with a transient cerebral hypoxic and/or
ischemic condition and, within 16 hours of onset of the condition,
administering to the subject a continuous intravenous infusion
dose of methamphetamine wherein the continuous infusion dose
is administered in an amount sufficient to reduce brain cell death
caused by the condition.
Appeal Br. 16 (Claims App’x).
The following rejections are appealed:
i. Claims 1—26 stand provisionally rejected on the ground of
nonstatutory obviousness-type double patenting over claims 21—28, 31—36,
38, 39 of co-pending Application No. 12/438,518. Final Action 13.
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ii. Claims 1, 3—7, 12—14, 15, 18—22, 25, and 26 stand provisionally
rejected on the ground of nonstatutory obviousness-type double patenting
over claims 1, 2, 4, and 5 of co-pending Application No. 13/940,101. Id.
iii. Claims 1—26 stand rejected under 35 U.S.C. § 103(a) over
Epstein2 and Stephenson.3 Id. at 15.
iv. Claims 1—14 stand rejected under 35 U.S.C. § 103(a) over
Stephenson. Id. at 19.
v. Claims 2—4, 8, 13—26 stand rejected under 35 U.S.C. § 103(a) over
Stephenson and Epstein. Id. at 22.
Regarding the double patenting rejections listed above as i. and ii.,
U.S. Patent Application No. 12/438,518 is abandoned (see Notice mailed
June, 23, 2017) and U.S. Patent Application No. 13/940,101 is abandoned
(see Notice mailed Oct. 2, 2015); therefore, these rejections are dismissed.
Because the obviousness rejections over Stephenson and Epstein
listed above as iv. and v. are cumulative of the first obviousness rejection
over the same references listed above as iii., we vacate rejections iv. and v.4
FINDINGS OF FACT
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the claims and prior art, and conclusions set out in the Final
2 WO 2005/000203 A2 (pub. Jan. 6, 2005) (“Epstein”).
3 US 2004/0176378 A1 (pub. Sept. 9, 2004) (“Stephenson”).
4 “[Wjhere a rejection is predicated on two references each containing
pertinent disclosure ... we deem it to be of no significance, but merely a
matter of exposition, that the rejection is stated to be on A in view of B
instead of on B in view of A, or to term one reference primary and the other
secondary.” In re Bush, 296 F.2d 491, 496 (CCPA 1961).
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Action and Answer. See Final Action 15—25 and Answer 2—28. Findings of
fact set forth below highlight certain evidence.
FF1. Stephenson discloses “treatment of reduced blood flow to
the central nervous system” to “prevent[] ischemic-mediated central
nervous system damage,” e.g., from “ischemic stroke,” by
administering amphetamine/methamphetamine (and a
cycloocygenase-2 selective inhibitor). Stephenson Abstract, || 2,
421, claims 1, 5, 7; see also Final Action 15—25 and Answer 2, 4—16,
18—28 (discussing Stephenson).
FF2. Stephenson disclosed:
The pathology underlying ischemic-mediated central nervous
system injury has been elucidated. Generally speaking, the
normal amount of perfusion to brain gray matter is 60 to 70
mL/100 g of brain tissue/min. Death of central nervous system
cells typically occurs only when the flow of blood falls below a
certain level (approximately 8-10 mL/100 g of brain tissue/min)
while at slightly higher levels the tissue remains alive but not
able to function. For example, most strokes culminate in a core
area of cell death (infarction) in which blood flow is so
drastically reduced that the cells usually cannot recover. This
threshold seems to occur when cerebral blood flow is 20 percent
of normal or less. Without neuroprotective agents, nerve cells
facing 80 to 100percent ischemia will be irreversibly damaged
within a few minutes. Surrounding the ischemic core is
another area of tissue called the “ischemic penumbra” or
“transitional zone” in which cerebral blood flow is between 20
and 50 percent of normal. Cells in this area are endangered,
but not yet irreversibly damaged. Thus, in the acute stroke, the
affected central core brain tissue may die while the more
peripheral tissues remain alive for many years after the initial
insult, depending on the amount of blood the brain tissue
receives.
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At the cellular level, if left untreated, rapidly within the core
infarction, and over time within the ischemic penumbra, brain
or spinal cell injury and death progress in stepwise manner.
Stephenson || 4—5 (emphasis added); see also Final Action 15—25 and
Answer 2, 4—16, 18—28 (discussing Stephenson).
FF3. Stephenson further discloses:
Several studies indicate that treatment with amphetamine
following ischemic-mediated central nervous system injury may
also be beneficial. Because amphetamines are known to
stimulate several neurotransmitters, including serotonin and
norepinephrine, they are believed to reverse or lessen the adverse
effects of central nervous system ischemic injury by providing
stimulation lost from the infarct region (e.g. thereby increase
neuronal firing) and also by increasing metabolism in regions
adjacent to injured cortex.
Stephenson 17; see also Final Action 15—25 and Answer 2, 4—16, 18—
28 (discussing Stephenson).
FF4. Stephenson discloses treating with methamphetamines to
prevent cell death “to treat a number of conditions resulting from a
reduction in blood flow to the central nervous system,” including
stroke, heart surgery, and trauma or injury to the brain or spinal cord,
but that “it is contemplated that the composition may be employed to
treat any central nervous system ischemic condition irrespective of the
cause of the condition” by “reduc[ing] the size of the ischemic
penumbra.” Stephenson || 440-46; see also Final Action 15—25 and
Answer 2, 4—16, 18—28 (discussing Stephenson).
FF5. Stephenson discloses:
Generally speaking, the amphetamine and cyclooxygenase-2
selective inhibitor are administered to the subject as soon as
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possible after the reduction in blood flow to the central nervous
system in order to reduce the extent of ischemic damage.
Typically, the amphetamine and cyclooxygenase-2 selective
inhibitor are administered within 10 days after the reduction of
blood flow to the central nervous system and more typically,
within 24 hours. In still another embodiment, the amphetamine
and cyclooxygenase-2 selective inhibitor are administered from
about 1 to about 12 hours after the reduction in blood flow to
the central nervous system. In another embodiment, the
amphetamine and cyclooxygenase-2 selective inhibitor are
administered in less than about 6 hours after the reduction in
blood flow to the central nervous system. In still another
embodiment, the amphetamine and cyclooxygenase-2 selective
inhibitor are administered in less than about 4 hours after the
reduction in blood flow to the central nervous system. In yet a
further embodiment, the amphetamine and cyclooxygenase-2
selective inhibitor are administered in less than about 2 hours
after the reduction in blood flow to the central nervous system.
Stephenson 1431 (emphasis added); see also Final Action 15—25 and
Answer 2, 4—16, 18—28 (discussing Stephenson).
FF6. Stephenson discloses “formulations for parenteral
administration can be in the form of aqueous or non-aqueous isotonic
sterile injection solutions or suspensions,” and “the amphetamine can
be administered intravenously, parenterally.” Stephenson || 407,
427; see also Final Action 15—25 and Answer 2, 4—16, 18—28
(discussing Stephenson).
FF7. Stephenson discloses an example where drug efficacy in
stroke is tested on rats using middle cerebral artery occlusion
(MCAO, i.e., induced stoke) models, as well known in the art, and
that “treatment, the combination [methamphetamine] therapy can be
administered, e.g., intravenously over 6 hours beginning 1, 2, 4, 5, 6,
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7,12, or 24 hours after MCAO” and “[i]t should be noted that
different doses, routes of administrations, and times of administration
can also be readily tested.” Stephenson || 462—63 (emphasis added);
see also Final Action 15—25 and Answer 2, 4—16, 18—28 (discussing
Stephenson).
FF8. Stephenson discloses:
The actual effective amounts of compound or drug can and will
vary according to the specific composition being utilized, the
mode of administration and the age, weight and condition of the
subject. Dosages for a particular individual subject can be
determined by one of ordinary skill in the art using conventional
considerations. But in general, the amount of amphetamine will
be between about 0.5 to about 150 milligrams per day and more
typically, between about 2.5 to about 50 milligrams per day. The
daily dose can be administered in one to four doses per day.
Stephenson 1428; see also Final Action 15—25 and Answer 2, 4—16,
18—28 (discussing Stephenson).
FF9. Stephenson discloses that the methamphetamine therapy
can “be administered for 12 weeks ... by any route as described.”
Stephenson 1448; see also Final Action 15—25 and Answer 2, 4—16,
18—28 (discussing Stephenson).
FF10. Epstein discloses, “the method includes administering a[]
1 -methampetamine compound” to treat cognitive impairments caused
by a variety of conditions. Epstein Abstract; see also Final Action
15—19, 22—25 and Answer 2—6, 10-19, 22, 26—28 (discussing
Epstein).
FF11. Epstein discloses using amphetamine/methamphetamine
compounds to treat a subject that has experienced brain injury, stroke,
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and/or traumatic brain injury, among several other conditions, for
example exposure to muscarinic cholinergic receptor antagonists.
Epstein, inter alia, 20:14—25, 82:9-23; see also Final Action 15—19,
22—25 and Answer 2—6, 10-19, 22, 26—28 (discussing Epstein).
FF12. Epstein discloses that treatment with methamphetamine
“can halt, reverse or diminish the progression of the impairment in
cognition and memory.” Epstein 57:2—5; see also Final Action 15—19,
22—25 and Answer 2—6, 10-19, 22, 26—28 (discussing Epstein).
FF13. Epstein discloses methamphetamine “can be
administered to a[n] individual acutely (briefly or short-term) or
chronically (prolonged or long-term) before, concomitantly with or
subsequent to exposure of the individual to a muscarinic cholinergic
receptor antagonist,” which suggests treating a patient soon after a
stroke or traumatic brain injury, or other relevant incident, and
continuing that treatment long-term if necessary. Epstein 86:12—15;
see also Final Action 15—19, 22—25 and Answer 2—6, 10-19, 22, 26—
28 (discussing Epstein).
FF14. Epstein disclose that methamphetamine “can be
administered hours (e.g., about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 12 hours),
days (e.g., about 1, 2, 3, 4, 5, 6, 7 days), weeks (e.g., about 1, 2, 3, 4,
5, 6, 7, 8 weeks), months (e.g., about 1,2, 10 3, 4, 5, 6, 7, 8, 9, 10, 11
months) or years (e.g., about 1, 2, 3, 4, 5 years) subsequent to
exposure of the individual to the muscarinic cholinergic receptor
antagonist,” which also suggests it can be administered for the same
time/duration after stroke or traumatic brain injury. Epstein 86:7—11;
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see also Final Action 15—19, 22—25 and Answer 2—6, 10-19, 22, 26—
28 (discussing Epstein).
FF15. Epstein discloses administering methamphetamine
parenterally, including intravenously and via infusion. Epstein
121:16—31; see also Final Action 15—19, 22—25 and Answer 2—6, 10-
19, 22, 26—28 (discussing Epstein).
FF16. Epstein discloses formulating methamphetamine for
parenteral administration, e.g., in unit dosage form, prepared by any
methods known in the art of pharmacy. Epstein 127:2—5; see also
Final Action 15—19, 22—25 and Answer 2—6, 10-19, 22, 26—28
(discussing Epstein).
FF17. Epstein discloses “pharmaceutical preparations []
formulated for variable dosing ... to deliver sustained and increasing
dose, e.g., over at least 4 hours.” Epstein 18:19—21; see also Final
Action 15—19, 22—25 and Answer 2—6, 10-19, 22, 26—28 (discussing
Epstein).
FF18. Epstein discloses methamphetamine doses of about
0.001 mg to about 1000 mg, with a preferred dose of between about
1 mg and about 150 mg. Epstein 30:18—29; see also Final Action 15—
19, 22—25 and Answer 2—6, 10-19, 22, 26—28 (discussing Epstein).
FF19. Epstein discloses methamphetamine doses of about 0.04
mg/kg to around 3.5 mg/kg. Epstein 32:14—18; see also Final Action
15—19, 22—25 and Answer 2—6, 10-19, 22, 26—28 (discussing
Epstein).
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DISCUSSION
Only those arguments made by Appellants in the Appeal Brief and
properly presented in the Reply Brief have been considered in this Decision.
Arguments not so presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473 (BPAI
2010) (informative) (“Any bases for asserting error, whether factual or legal,
that are not raised in the principal brief are waived.”).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[T]he analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418. “Aprima facie case of obviousness typically exists when the ranges of
a claimed composition overlap the ranges disclosed in the prior art.” In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). “[T]he discovery of an
optimum value of a variable in a known process is normally obvious.”
Exceptions to this rule include (1) the results of optimizing a variable were
unexpectedly good and (2) the parameter optimized was not recognized in
the prior art as one that would affect the results. In re Antonie, 559 F.2d
618, 620 (CCPA 1977).
In analyzing patentability in view of the prior art, “a reference is not
limited to the disclosure of specific working examples.” In re Mills, 470
F.2d 649, 651 (CCPA 1972)). “[A] prior art publication cited by an
Examiner is presumptively enabling barring any showing to the contrary by
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a patent applicant.” In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed.
Cir. 2012).
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Further,
As adapted to ex parte procedure, Graham [v. John Deere Co.,
383 U.S. 1 (1966)] is interpreted as continuing to place the
“burden of proof on the Patent Office which requires it to
produce the factual basis for its rejection of an application under
sections 102 and 103.” After a prima facie case of obviousness
has been established, the burden of going forward shifts to the
applicant. Rebuttal is merely a “showing of facts supporting the
opposite conclusion,” and may relate to any of the Graham
factors including so-called secondary considerations. If rebuttal
evidence of adequate weight is produced, the holding of prima
facie obviousness, being but a legal inference from previously
uncontradicted evidence, is dissipated.
In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984) (citations omitted).
One such “secondary consideration” for non-obviousness is evidence
of unexpected results. “[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991). “Mere recognition of latent properties in the prior art does not
render nonobvious an otherwise known invention.” In re Baxter Travenol
Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Expected beneficial results are
not evidence of non-obviousness. See In re Skoner, 517 F.2d 947, 950
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(CCPA 1975); see also Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371
(Fed. Cir. 2007).
Another “secondary consideration” for non-obviousness is evidence
of long-felt, but unresolved need. Establishing long-felt need requires
objective evidence showing: (i) a need has been a persistent one that was
recognized by ordinarily skilled artisans; (ii) the long-felt need must not
have been satisfied by another before Appellant’s invention; and (iii) the
invention must, in fact, satisfy the long-felt need. In re Gershon, 372 F.2d
535, 538 (CCPA 1967); Newell Companies, Inc. v. Kenney Mfg. Co., 864
F.2d 757, 768 (Fed. Cir. 1988); In re Cavanagh, 436 F.2d 491, 496 (CCPA
1971).
The Examiner determined that Epstein and Stephenson taught a
method of reducing brain cell death caused by, inter alia, stroke and/or
traumatic brain injury, by treating the subject of such conditions with
methamphetamine. FF1—FF4, FF7, FF11—FF13. The Examiner determined
that the prior art combination taught that the treatment with
methamphetamine should be provided at least within 16 hours of the onset
of the condition causing the need therefor. FF2, FF5, FF7, FF12—FF14. The
Examiner determined that Epstein and Stephenson taught that the
methamphetamine should be formulated so as to be delivered parenterally
and should be provided as a continuous intravenous infusion. FF6—FF9,
FF13, FF14, FF15. The Examiner determined that Epstein and Stephenson
taught that such a treatment would be sufficient to reduce brain cell death
caused by the condition. FF1—FF4, FF7, FF8. The Examiner also
determined that the prior art combination taught the limitations of the
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dependent claims, e.g., bolus, dosing, timing, and human subjects. FF5,
FF7, FF8, FF15—FF19. We conclude the Examiner has established a prima
facie case for the obviousness of claims 1—26 over the cited prior art
combination. Appellants have not established any error in the Examiner’s
determinations. We address Appellants’ arguments below.
To the extent Appellants argue the references individually, we do not
find such arguments persuasive because the rejection is over a combination
of prior art. “Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. [The references] must be read, not in isolation,
but for what [they] fairly teach [] in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants argue Epstein fails to teach administration of a continuous
intravenous infusion. Appeal Br. 7. This is not persuasive. First, as noted
above, non-obviousness cannot be established by attacking the references of
a combination individually. Further, Epstein teaches that
methamphetamines can be administered to repair brain function either
briefly for a short-term or prolonged over a long-term and that such
administration can be via infusion. FF13, FF15. Moreover, Stephenson
teaches that methamphetamines can be administered to prevent brain cell
death by intravenous infusion for 6 hours following stroke. FF6, FF7.
Appellants argue that it would not have been obvious to optimize the
timing of methamphetamine administration taught by Stephenson. Appeal
Br. 8, 11. This argument is not persuasive. Stephenson emphasizes the
urgency of methamphetamine treatment after any incident that causes
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ischemia to prevent nerve cell death, urging that treatment should be
“administered to the subject as soon as possible after the reduction in blood
flow,” and identifying that such urgent treatment takes place in a time frame
of between 1 hour and 10 days after the incident, but most preferably less
than 2 hours thereafter. FF2, FF4, FF5. Thus, even without obvious
optimization of timing, Stephenson explicitly teaches acute
methamphetamine treatment besting the recited timing of the claims with
respect to rapidity.
Appellants argue the skilled artisan would not have been motivated to
modify the methods of Epstein in view of Stephenson because they are
directed to different things. Appeal Br. 8,12. Appellants further argue
Stephenson cannot be used as prior art because it does not provide data or
working examples. Id. at 9, 11. These arguments are not persuasive.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR, 550 U.S. at 416. The obviousness analysis “can take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ” and “[a] person of ordinary skill is also a person of ordinary
creativity, not an automaton.” Id. at 418, 421. A prior art reference is
analogous and thus can be used in an obviousness combination if it “is from
the same field of endeavor, regardless of the problem addressed” or “is
reasonably pertinent to the particular problem with which the inventor is
involved.” Unwired Planet, LLCv. Google Inc., 841 F.3d 995, 1000-01
(Fed. Cir. 2016) (quoting In re Clay, 966 F.2d 656, 658—59 (Fed. Cir.
1992)).
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Here, contrary to the narrow view taken by Appellants, Epstein and
Stephenson are directed to the same field of endeavor, which is treating
conditions that cause brain damage, for example, stroke and traumatic brain
injury. While Stephenson may more specifically identify the causation
involved in such brain damage, that is, the death of brain cells from
ischemia, and Epstein more generally identifies the results of such damage,
cognitive impairment, each reference identifies a common remedy, which is
administration of amphetamines/methamphetamines soon after the condition
arises. Thus, the skilled artisan, not being a mere automaton, would have
had ample motivation to combine these references. Moreover, as noted
above, there is no requirement that a prior art reference provide specific
working examples and data to render claims unpatentable. As also identified
above, an examiner-cited reference is presumed enabling and Stephenson
discloses preventing brain cell death caused by ischemia by treatment with
methamphetamines infusion within 2 hours of incident.
Appellants argue unexpected results, i.e., that treating with
methamphetamines during an acute period after the onset of the condition
requiring therapy (specifically within 16 hours) can reduce brain cell death,
is evidence of non-obviousness. Appeal Br. 7, 9, 10, 13 (citing Poulsen
Deck5H4—7 and Chopp Deck6 H 9-10); Reply 4—6. This argument is not
persuasive. As indicated above, a result must be unexpected to be evidence
on non-obviousness. Here, treatment within 16 hours or far sooner was not
5 Declaration of Dr. David J. Poulsen under 37 C.F.R. § 1.132 (dated Dec.
17,2014) (“Poulsen Deck”).
6 Declaration of Dr. Michael Chopp under 37 C.F.R. § 1.132 (dated Jan. 6,
2015) (“Chopp Deck”).
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new nor was the effective result of such acute treatment unexpected in view
of the fact that Stephenson urges acute treatment within 2 hours of incident
to prevent cell death. FF2, FF5, FF7. Additionally, Epstein also teaches
acute treatment with methamphetamines. FF13.
Appellants also argue, again citing to the Poulsen Decl. and Chopp
Decl., that there was a long-felt need for drugs in reducing brain cell death
and that this is evidence of non-obviousness. Appeal Br. 11; Reply 4—6.
This argument is not persuasive. As noted above, to provide evidence on
non-obviousness, a long-felt need must not have been satisfied by another
before Appellants’ invention. Here, it is apparent that administering
methamphetamines to stroke or traumatic brain injury victims, as taught by
Stephenson and Epstein, would satisfy the need in the art for an effective
treatment to mitigate cell death and cognition impairment.
For the reasons above, we affirm the obviousness rejection.
SUMMARY
The double patenting rejections are dismissed.
The obviousness rejection is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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