Ex Parte Epstein-Barash et al

Patent Trial and Appeal Board

Oct 25, 2016

13263804 (P.T.A.B. Oct. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/263,804 10/10/2011
23579 7590 10/26/2016
Pabst Patent Group LLP
1545 PEACHTREE STREET NE
SUITE 320
ATLANTA, GA 30309
FIRST NAMED INVENTOR
Hila Epstein-Barash
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.
CMCC 1851/MIT 13716 4790
EXAMINER
ARON, KIMBERLY A
ART UNIT PAPER NUMBER
1633
MAILDATE DELIVERY MODE
10/26/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HILA EPSTEIN-BARASH and
DANIELS. KOHANE 1
Appeal2015-002920
Application 13/263,804
Technology Center 1600
Before DEMETRA J. MILLS, JOHN G. NEW, and RY ANH. FLAX,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
1 Appellants state the real parties-in-interest are Children's Medical
Corporation and Massachusetts Institute of Technology. App. Br. 2.
Appeal2014-0002920
Application 13/263,804
DECISION ON APPEAL
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-8 and 17-21. Specifically, claims
1---6 and 17-19 stand rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Kohane et al. (US 6,326,020 B 1,
December 4, 2001) ("Kohane '020") and Kohane et al. (US 2005/0202093
Al, September 15, 2005) ("Kohane '093").
Claims 1-8 and 17-21 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Kohane '020, Kohane
'093, Lim et al. (US 5,858,397, January 12, 1999) ("Lim") and J. Wu et al.,
Lipid-Based Nanoparticulate Drug Delivery Systems, NANOPARTICULATE
DRUG DELIVERY SYSTEMS, (D. Thassu et al., eds.), 89-98 (2007) ("Wu").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to compositions containing site I
sodium channel blockers for use as local anesthetics with rapid nerve block,
improved potency and efficacy, and no local toxicity. Liposomes were
employed for increased loading of the site I sodium channel blocker.
Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. An injectable composition for rapid onset nerve blockade,
consisting of between 28 and 2800 micrograms of a site I sodium
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channel blocker, in a liposome, wherein the composition is
effective to provide reliable prolonged nerve blockade in the
absence of local toxicity relative to the site I sodium channel
blocker encapsulated in a polymeric microparticle.
App. Br. 18.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are prima facie obvious over the references cited by
the Examiner. We address the arguments raised by Appellants below.
A. Claims 1, 2, 5-8, and 17
Issue
Appellants argue the Examiner erred because a person of ordinary
skill would have had no reasonable expectation of success in combining the
references and because Appellants have demonstrated unexpected results.
App. Br. 13-14.
Analysis
Appellants rely upon three prior art references in their effort to rebut
the Examiner's prim a facie conclusion of obviousness: (1) D.S. Kohane et
al., A Re-examination of Tetrodotoxin for Prolonged Duration Local
Anesthesia, 89(1) ANESTHESIOLOGY 119-131(July1998) ("Kohane 1998");
(2) D.S. Kohane et al., Prolonged Duration Local Anesthesia from
Tetrodotoxin-enhanced Local Anesthetic Microspheres, 104 PAIN 415--421
(2003) ("Kohane 2003"); and (3) C.S. Barnet et al., Tissue Injury from
Tricyclic Antidepressants Used as Local Anesthetics, 101 ( 6) ANESTH. &
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ANALG. 1838-1843 (2005) ("Barnet 2005"). Appellants argue that these
references, and the prior art cited by the Examiner, teach away from
Appellants claimed invention and, therefore, a person of ordinary skill in the
art would have had no reasonable expectation of successfully modifying the
prior art to arrive at the claimed subject matter. App. Br. 13.
Appellants point to their Specification, which discloses that both
tetrodotoxin and saxitoxin, both site I sodium channel antagonists, are too
toxic to be used alone. App. Br. 13 (citing Spec. i-fi-122-23). Appellants
assert that Kohane 1998 teaches that administration of TTX without
epinephrine has been shown to produce sciatic nerve block, but with
considerable toxicity at the most effective doses. Id. at 13-14 (Kohane 1998
Abstr.). Appellants argue this teaches away from using a site I sodium
channel blocker alone in a liposomal formulation, as required by claim 1.
Id. at 14. According to Appellants, the prior art neither teaches nor suggests
that, by putting the formulations into polymeric microparticles, one could
obtain greater duration of the blockade and less toxicity by incorporating the
formulation into liposomes. Id. Appellants argue a person of ordinary skill
in the art, with knowledge of the teachings ofKohane 1998, would have
concluded that a liposomal formulation containing only a type I sodium
channel blocker would result in toxicity. Id.
Appellants argue further that Kohane 2003 teaches that polymeric
microspheres containing tetrodotoxin alone were lethal at 0.1 % w/w and
ineffective in blockading pain at 0.05%. App. Br. 14 (citing Kohane 2003
Abstr.). Furthermore, Appellants assert, almost all of the test animals
demonstrated local muscle injury after administration. Id. (citing Kohane
2003 418). Furthermore, Appellants argue, Barnet 2005 and Kohane 1998
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both teach that it is ditlicult to encapsulate effective amounts of potent local
anesthetics in polymeric particles because the local anesthetics are
hydrophilic and the systemic toxicity from their initial rapid release is dose-
limiting. Id. Consequently, Appellants assert, in view of the teachings of
Kohane 1998, Kohane 2003, and Barnet 2005, one of ordinary skill in the art
would not have been motivated to modify the cited references to arrive at
Appellants' claimed invention because to do so would result in a formulation
that caused local toxicity, contrary to the express requirements of claim 1.
Id. at 15.
Appellants also dispute the Examiner's finding that the recited range
of site I sodium channel blocker would be the result of routine optimization.
App. Br. 15. Appellants contend that the prior art teaches the use of toxins
alone resulted in local toxicity and injury. Id. Therefore, Appellants
contend, a person of ordinary skill in the art would not be motivated to
optimize the dosage of site I sodium channel blocker because such
formulations would nevertheless result in a formulation that causes local
toxicity and injury. Id.
The Examiner responds that Kohane 199 8 teaches that there were
effective doses of tetrodotoxin alone that were not toxic. Ans. 9 (citing
Kohane 21; Fig. 1; Table 1). The Examiner finds Kohane 1998 does not
explicitly teach away from administration of tetrodotoxin alone, and that a
reference may be relied upon for all that it would have reasonably suggested
to one having ordinary skill the art, including nonpreferred embodiments.
Id. (citing Merck & Co., Inc. v. Biocraft Laboratories, Inc., 87 4 F .2d 804,
807 (Fed. Cir. 1989).
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With respect to Appellants' argument that reading the Specification in
combination with Kohane 1998 would lead a person of ordinary skill to
conclude that liposomal formulations containing only a type I sodium
channel blocker would result in toxicity, the Examiner finds Kohane 1998 is
quite clear that there are effective doses of tetrodotoxin alone that were not
toxic. Ans. 9 (citing Kohane 1998 21; Fig. 1; Table 1 ).
The Examiner also finds Appellants' Specification does not teach or
suggest that formulations containing only a type I sodium channel blocker
would result in toxicity. Id. The Examiner finds Appellants' Specification
acknowledges that it was known at the time of filing that "[t]etrodotoxin
alone is too toxic to be used as an anesthetic" and "[ s ]axitoxin is too toxic to
be used alone as a local anesthetic" does not necessarily convey that the
Specification teaches or suggests that all site I sodium channel blockers
cannot be administered alone. Id. (see Spec. 5). The Examiner finds that it
was known that tetrodotoxin and saxitoxin are two species of a larger genus
of "type I sodium channel blockers," and the Specification makes no such
claims about any other type I sodium channel blocker. Id.; see Spec. 5.
The Examiner also finds the Specification is not specific as to whether
the site I sodium channel blockers are administered "alone" (i.e., outside of a
carrier) or "alone" (i.e., in a carrier without any co-administered with other
agents such as local anesthetics, vasoconstrictors, glucocorticoids, or
adrenergic drugs). Id. The Examiner therefore finds that a person of
ordinary skill would not reasonably conclude that the instant specification
would lead one to conclude that liposomal formulations containing only a
type I sodium channel blocker with no carrier would result in toxicity. Id. at
9-10.
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The Examiner next addresses Appellants' argument that none of the
cited prior art would have led a person of ordinary skill to substitute
liposomes for polymeric carriers would provide prolonged nerve blockade in
the absence of local toxicity. Ans. I 0. The Examiner finds that a person of
ordinary skill in the art would have had a reasonable expectation of success
of creating a composition substituting liposomes for polymeric carriers
because liposomes and polymeric carriers are both explicitly taught for
encapsulating site I sodium channel blockers. Id. (citing Kohane '093 i-fi-1 8;
30; 35-37; 43; Kohane '020 Abstr., col. 8, 11. 65----67; col. 9, 11. 28-30). The
Examiner finds these compositions are functional equivalents in the art as
delivery vehicles, and concludes that substituting one for the other would
have been obvious at the time of the invention. Id. (citing KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007).
The Examiner further finds Appellants' submitted rebuttal art, Kohane
1998, Kohane 2003, and Barnet 2005, do not overcome the Examiner's
prima facie case of obviousness. Ans. 11. The Examiner finds the data
presented in Kohane 2003, Barnet 2005, and Kohane 1998 does not
adequately represent the entire scope of the claimed invention, and it does
not present truly unexpected and unobvious results that are both statistically
and practically significant. Id.
We are not persuaded by Appellants' arguments. We agree with the
Examiner that the cited prior art references, as combined, teach or suggest
the limitations of claim 1. Kohane '020, for example, teaches the use of
liposomes as a carrier of tetrodotoxin and the concentration ranges recited in
claim 1. Kohane '020 col. 9, 11. 28-35; col. 10, 11. 19-29. Similarly, Kohane
'093 teaches:
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Any type of microparticle known in the art can be used to deliver
the desired pharmaceutical agent to the diseased tissue or site
with the unwanted electrical activity. The type of microparticles
useful in the inventive system include liposomes, spray-dried
particles, microspheres formed by single- and double-emulsion
techniques, microparticles produced off of a micropattemed
surface, and microparticles formed by spray drying,
coacervation, or spontaneous emulsification.
Kohane '093 i-f 30 (emphasis added). 2 The Examiner has thus provided
evidence to support a prima facie case of obviousness.
In their Reply Brief, Appellants dispute the Examiner's finding that
the claim limitation reciting "[ w ]herein the amount of the site I sodium
channel blocker is effective to: [p]rovide reliable prolonged nerve
blockade[;] [i]n the absence of local toxicity relative to the site I sodium
channel blocker," is not a structural limitation of the claimed composition
and is given no weight. Reply Br. 2; see Ans. 8. Appellants argue the claim
term "amount of the site I sodium channel blocker is effective to," i.e., the
"effective amount" must be construed by the Board in light of the
Specification and be accorded weight as a limitation of the claim. Id. at 4.
According to Appellants, their Specification clearly defines what effective
dosages are and how to test for efficacy and toxicity. Id. at 5. Appellants
assert the dosages taught by the prior art must be different in polymeric
particles as compared to liposomes due to the greater toxicity and lower
efficacy in the polymeric particles. Id. at 5.
2 At oral argument, Appellants' counsel intimated that the liposomes
disclosed by Kohane '093 were somehow different from the liposomes
required of the invention; however, neither the appealed claims themselves
nor the Specification distinguish the claimed liposomes in any way, other
than being either solid or fluid in nature. See, e.g., Spec. 3:25-29, 6:10-21.
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However, even if we find, arguendo, that Appellants are correct with
respect as to whether the disputed limitation must be given weight in a
composition claim, we are not persuaded by Appellants that the prior art
would fail to teach or suggest the limitation. The "effective amount" recited
in claim 1 must consist of "between 28 and 2800 micrograms of a site I
sodium channel blocker" as required by the claim. Kohane '020 teaches the
use of liposomes and further teaches:
Dosage ranges are between 5 and 17 5 mg for bupivacaine
alone, between 28 and 2800 micrograms for tetrodotoxin alone,
between 7 and 2800 micrograms tetrodotoxin alone or in
combination with bupivacaine in combination with between
1 :200,000 and 1 :5,000,000 epinephrine, 7 and 700 micrograms
saxitoxin alone or in combination with bupivacaine, one to 700
micrograms saxitoxin alone or in combination with bupivacaine
with between 1 :200,000 and 1 :5,000,000 epinephrine, and any of
these combinations with between 0.05 and 1 mg
dexamethasone/mg.
Kohane '020 col. 10, 11. 19-28 (emphasis added). Kohane '020 thus teaches
the same range for a site I sodium channel blocker (tetrodotoxin) as is
recited in claim 1. Furthermore, means of assessing the duration and
effectiveness of sensory blockade and myotoxicity were well known in the
art at the time of invention, as taught, at least, by Appellants' submitted
references. See, e.g., Kohane 1998 121; Kohane 2003 416. We conclude
that a person of ordinary skill in this highly-skilled art, upon learning the
teachings of Kohane '020 and understanding methods of determining
sensory blockade and assessment of toxicity that were well known in the art,
would have been able, as a matter of optimization, to determine an effective
amount of site I sodium channel blocker. See In re Aller, 220 F.2d 454, 456
(C.C.P.A. 1955) ("[W]here the general conditions of a claim are disclosed in
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the prior art, it is not inventive to discover the optimum or workable ranges
by routine experimentation."); see also In re Boesch, 617 F.2d 272, 276
(C.C.P.A. 1980) ("[D]iscovery of an optimum value of a result effective
variable ... is ordinarily within the skill of the art").
Appellants' primary argument in their Appeal Brief relies upon their
submitted rebuttal prior art as allegedly demonstrating that a person of
ordinary skill in the art would have been discouraged or deterred from
combining the references in the manner explained by the Examiner. See
App. Br. 14. However, none of Appellants' submitted prior art references
address the use of liposomes or different types of liposomes as carriers.
Kohane 1998, for instance, teaches that direct injection of tetrodotoxin alone
to the region of the sciatic nerve resulted in blockade of thermal nociception
but, in effective doses, also exhibited significant toxicity. Kohane 1998 123.
Kohane 2003 studies the efficiency of using "microparticles
composed of poly (lactic-co-glycolic) acid (PLGA)" in effecting sensory
blockade when used as a carrier for tetrodotoxin alone, tetrodotoxin
combined with either bupivacaine or dexamethasone, or a combination of all
three. Kohane 2003 415--416; see also Fig. 1. Kohane 2003 teaches that the
encapsulated combination of tetrodotoxin, bupivacaine, and dexamethasone
has a synergistic effect in producing longer-lasting sensory blockade, but
that all animals tested exhibited some level of local anesthetic myotoxicity.
Id. at 419--420.
Finally Barnet 2005 teaches that use of the tricyclic antidepressants
doxepin and amitriptyline caused significant tissue injury at concentrations
less than what would be required to provide clinical effectiveness and more
toxicity than bupivacaine. Barnet 2005 1842. Barnet 2005 is silent with
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respect to site l sodium channel blockers such as tetrodotoxin and saxitoxin
as well as the use of liposomes as a carrier. Appellants argue that Kohane
1998 and Barnet 2005 teach that it is extremely difficult to encapsulate
effective amounts of potent local anesthetics in polymeric particles because
the local anesthetics are hydrophilic and the systemic toxicity from their
initial rapid release is dose-limiting. See App. Br. 14. However, we do not
see the relevance of these teachings to the use of liposomes as carriers.
A "teaching away" requires a reference to actually criticize, discredit,
or otherwise discourage the claimed solution. See In re Fulton, 391 F.3d
1195, 1201 (Fed. Cir. 2004). Given that all three rebuttal references relied
upon by Appellants are silent with respect to the use of liposomes, and that
one is silent as well with respect to the use of the site I sodium channel
blockers taught by the Examiner's cited art (i.e., tetrodotoxin and saxitoxin),
and given that all three references demonstrate a degree of success, even if
incomplete, we cannot agree with Appellants' contention that these
references constitute a teaching away from Appellants' claimed invention.
See In re Dunn, 349 F.2d 433, 438 (C.C.P.A. 1965) (Teaching an alternative
or equivalent method does not teach away from the use of a claimed
method). Indeed, it is possible that the lack of complete success recited in
Appellants' rebuttal references could have motivated a person of ordinary
skill in the art to attempt to employ an alternative carrier, such as a
liposome, as taught by Kohane '020 and Kohane '093. Consequently, we
find that Appellants' submitted rebuttal references do not teach away from
the claimed invention.
Furthermore, we do not agree with Appellants' argument that a person
of ordinary skill in the art would not have had a reasonable expectation of
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success. All of Appellants' submitted prior art references show a certain
degree of success in sensory blockade, and not all of the references
necessarily show toxicity. Kohane 1998, for instance, teaches that toxicity
can be significantly mitigated by co-administration of epinephrine and/or
bupivicaine. Kohane 1998 126. The fact that the employment of liposomes
as a carrier did not predictably provide long-term sensory blockade and
"absence of local toxicity relative to the site I sodium channel blocker
encapsulated in a polymeric microparticle" does not preclude a conclusion
of obviousness. Only a reasonable expectation of success, not absolute
predictability, is necessary for a conclusion of obviousness. In re Langi, 759
F.2d 887, 897 (Fed. Cir. 1985). We find nothing in Appellants' submitted
rebuttal prior art references that demonstrates that the teachings of the
Examiner's cited prior art, Kohane '020 and Kohane '093, would persuade a
person of ordinary skill in the art that there was no reasonable expectation of
success in combining the teachings of the references.
"[W]hen a prima facie case is made, the burden shifts to the applicant
to come forward with evidence and/or argument supporting patentability."
In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002). Appellants argue that
their invention provided unexpected results. However, in neither their
Appeal Brief nor in their Reply Brief do Appellants point to evidence
disclosed in their Specification that compares the alleged unexpected results
to the closest prior art to show that the results are unexpected or surprising.
Instead, Appellants' argument is that:
The specification discloses that both tetrodotoxin (TIX)
and [s]axitoxin are too toxic to be used alone. [Kohane 1998]
discloses that TTX without epinephrine has been shown to
produce sciatic nerve block, but with considerable toxicity at the
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most effective doses .... Kohane 1998 teaches that TTX produces
injury when used alone. This is a clear teaching away from using
a site I sodium channel blocker alone as required by claim 1 in a
liposomal formulation that has no local toxicity. The prior art
does not disclose that putting the formulations into polymeric
microparticles prolongs nerve blockade without toxicity, much
less that one could obtain greater prolongation and less toxicity
by incorporating into liposomes. Reading the specification in
combination with Kohane et al. would lead one of ordinary skill
in the art to conclude that liposomal formulations containing only
a type I sodium channel blocker would result in toxicity.
App. Br. 13-14. This is the single direct reference to the disclosures of
Appellants' Specification with respect to Appellants' alleged unexpected
results in either the Appeal or the Reply Brief. See also Reply Br. 9. That is
to say, Appellants make an assertion, unsupported by data from their
Specification, of unexpected results and then immediately pivot to the
teachings of their submitted rebuttal prior art, arguing that a person of
ordinary skill would not have had a reasonable expectation of success in
combining the Examiner's cited prior art. Essentially, Appellants make no
substantive argument, supported by evidence of record, in either brief that
their results actually were unexpected or surprising, but argue only that the
submitted references teach away from their invention and that a person of
ordinary skill would have had no reasonable expectation of success. That is
insufficient to either sustain their argument of unexpected results or
overcome the Examiner's primafacie conclusion of obviousness. 3 It is well
3 At oral argument, counsel for Appellants argued extensively that data
disclosed in the Specification, when compared with the data in their
submitted rebuttal references provided unexpected and surprising results.
Dr. Daniel S. Kohane, co-inventor of the claimed invention, also testified
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settled that arguments of counsel cannot take the place of factually supported
objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40 (Fed. Cir.
1996); In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
Consequently, we affirm the Examiner's rejection of the claims.
B. Claims 3, 4, and 18-21
Issue
Appellants argue the Examiner erred because a person of ordinary
skill in the art would not have had a reasonable expectation of success in
obtaining "prolonged nerve blockade in the absence of local toxicity relative
to the site I sodium channel blocker encapsulated in a polymeric
microparticle." App. Br. 15-16.
before the panel to the same end. However, we are compelled to afford little
probative value to evidence and arguments raised in oral argument that were
not adduced or argued in the briefs. See 37 C.F.R. § 41.47(e)(l) ("At the
oral hearing, appellant may only rely on Evidence that has been previously
entered and considered by the primary examiner and present argument that
has been relied upon in the brief or reply brief except as permitted by
paragraph ( e )(2) of this section") (emphasis added) (Paragraph ( e )(2) of 37
C.F.R. § 41.47 is not relevant to the instant circumstances). Because
Appellants provided no substantive argument in either brief comparing the
results disclosed in the Specification with data from the nearest prior art, we
do not accord Appellants' oral argument probative weight in this respect. If
prosecution should continue on this application and if Appellants intend to
rely on such evidence, it should be made of record with the Examiner,
preferably in the form of a Declaration.
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Analysis
Appellants assert that claim 3 requires, inter alia, ( 1) an injectable
composition consisting of between 28 and 2800 micrograms of a site I
sodium channel blocker; (2) an effective amount equivalent to 0.05 to 1 mg
dexamethasone/mg of glucocorticoid selected from the recited list; (3) in a
liposome; and ( 4) that the glucocorticoid enhance nerve block in the absence
of local toxicity relative to the site I sodium channel blocker alone.4 App.
Br. 15.
Appellants state the Examiner acknowledged that the cited art fails to
disclose between 28 and 2800 micrograms of a site I sodium channel blocker
and an effective amount of a glucocorticoid equivalent to 0.05 to 1 mg
dexamethasone/mg of glucocorticoid selected from the recited list. App. Br.
15. However, Appellants assert, the Examiner alleges that it would have
been a routine matter of optimization to arrive at the required dosages.
Appellants argue that, as argued with respect to the prior claims, their
submitted rebuttal prior art references teach the use of toxins to generate
nerve blockage resulted in local toxicity and injury. Id. at 15-16. Therefore,
Appellants argue, a person of ordinary skill in the art would not be
motivated to optimize the dosage of site I sodium channel blocker and
glucocorticoid because such formulations would still result in a formulation
that causes local toxicity and injury. Id. at 16.
4 Additionally, claim 3 neither recites, nor requires, a liposome, which was
argued by Appellants' counsel to be a critical and distinguishing claim
element. Counsel for Appellants acknowledged at oral argument that the
omission of a limitation reciting a liposome was an oversight, missed by
both Appellants and the Examiner during prosecution that would require
amendment of the claim.
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We are not persuaded by Appellants' argument. As we have related
supra, the Examiner's cited prior art teaches the limitations of claim 1 which
also apply to claim 3. Kohane '020 additionally teaches:
Corticosteroids that are useful to prolong in vivo nerve
blockade include glucocorticoids such as dexamethasone,
cortisone, hydrocortisone, prednisone, and others routinely
administered orally or by injection. Other glucocorticoids
include beclomethasone, betamethasone, flunisolide, methyl
prednisone, para methasone, prednisolone, triamcinolome,
alclometasone, amcinonide, clobetasol, fludrocortisone,
diflurosone diacetate, fluocinolone acetonide, fluoromethalone,
flurandrenolide, halcinonide, medrysone, and mometasone, and
pharmaceutically acceptable salts and mixtures thereof.
Kohane '020 col. 8, 11. 3-13. Kohane also teaches that dexamethasone can
be coadministered with 28-2800 micrograms of tetrodotoxin in dosages
"[of] between 0.05 and 1 mg dexamethasone/mg." Kohane '020 col. 10, 11.
27-28. We have further related why we conclude it would be within the
skill of an ordinaf'J artisan in this sophisticated art, \'l/orking from the
teachings of the Examiner's and Appellants' cited prior art, to optimize the
variables so as to arrive at Appellants' claimed invention.
We have also explained supra, our reasoning as to why a person of
ordinary skill in the art would be motivated, with a reasonable expectation of
success, to combine the teachings of Kohane '020 and Kohane '093. In
view of this reasoning with respect to claims 3, 4, and 18-21, we
consequently affirm the Examiner's rejection of the claims.
DECISION
The Examiner's rejection of claims 1-8 and 17-21 as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
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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)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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