Ex Parte Lin et al

Patent Trial and Appeal Board

Jul 29, 2016

13160663 (P.T.A.B. Jul. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/160,663 06/15/2011
24267 7590 08/02/2016
CESARI AND MCKENNA, LLP
88 BLACK FALCON AVENUE
BOSTON, MA 02210
FIRST NAMED INVENTOR
Hang-Ching LIN
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.
218057-0003 3817
EXAMINER
PARAD, DENNIS J
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
08/02/2016 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):
docket@c-m.com
USPTOMail@c-m.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HANG-CHING LIN, JING JING JUSTINE TANG,
MUH-HWAN SU, and YOUNG-MING HUANG
Appeal2014-009476
Application 13/160,663 1
Technology Center 1600
Before ERIC B. GRIMES, LORA M. GREEN, and
KRISTI L. R. SA WERT Administrative Patent Judges.
SA WERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims 1-14. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify Sinphar Tian-Li Pharmaceutical Co., Ltd. as the
real party in interest. Br. 2.
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Application 13/160,663
STATEMENT OF THE CASE
Claims 1-7 and 9-12 stand rejected under 35 U.S.C. § 102(b) for
anticipation by Dal Monte2. Claim 8 stands rejected under 35 U.S.C.
§ 103(a) for obviousness over Dal Monte. We choose independent claims 1
and 9 as representative. See 37 C.F.R. § 41.37(c)(l)(iv). Claim 1 provides:
1. A method for treating a disease or condition
associated with amyloid B peptides in an individual in need
thereof, comprising administering to the individual isoacteoside
or a pharmaceutically acceptable salt thereof at an amount
effective for inhibiting formation, accumulation, or aggregation
of the amyloid B peptides in the individual.
Br. 9. Claim 9 provides:
9. A method for inhibiting formation, accumulation
or aggregation of amyloid B peptides in an individual in need
thereof, comprising administering an effective amount of
isoacteoside or a pharmaceutically acceptable salt thereof to the
individual to inhibit the formation, accumulation or aggregation
of the amyloid B peptides.
Br. 10.
FINDINGS OF FACT
1. The claimed invention is directed to a method for treating a disease or
condition associated with the formation, accumulation, or aggregation
of amyloid B peptides, and a method for inhibiting the formation,
accumulation, or aggregation of amyloid B peptides. Br. 9-1 O; Spec.
1 (11. 11-15). The Specification explains that amyloid B (AB) peptides
2 Renzo Dal Monte et al., U.S. Publication No. 2007/0004011 Al
(Jan. 4, 2007).
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consist of 39 to 43 amino acids and are hydrolysis products of
amyloid precursor protein. Spec. 1 (11. 17-19). Diseases or
conditions associated with amyloid B peptides include Alzheimer's
disease. Id. (11. 19-21 ).
2. The Specification "discloses using isoacteoside ... or a
pharmaceutically acceptable salt thereof as an active ingredient for
inhibiting (e.g., reducing or preventing) AB formation, accumulation
or aggregation, and in particular AB extracellular formation,
accumulation or aggregation." Spec. 4 (11. 12-16). Isoacteoside is a
type of phenylethanoid glycoside, and is known in the art as a
component of medicinal preparations. Id. (11. 21-23). The
Specification states that "isoacteoside or its equivalent
pharmaceutically acceptable salt can be administered to a person in a
daily therapeutically effective amount of about 0.2 mg/kg to 4 mg/kg
(i.e., a recommended dosage of an adult weighted 60 kg of about 12
mg - 240 mg)." Spec. 18.
3. Dal Monte discloses phenylpropanoid extracts from plants having
"antioxidant activity" and "other important pharmacological
properties." Dal Monte ,-i 1. The extracts are used "in the preparation
of drugs, nutritional or cosmetic substances." Id. at ,-i 5. In particular,
Dal Monte teaches that the extracts "are valid tools in the prevention
and treatment of disease states associated with damage due to free
radicals." Id. at ,-i 112. Those disease states include Alzheimer's
disease and senile dementia. Id. at ,-i 113; see also Claim 31.
4. Dal Monte teaches that the extracts comprise "varying percentages of
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phenylpropanoids, such as for example verbascoside and
isoverbascoside and a series ofverbascoside analogues." Dal Monte
,-i 44. "Isoverbascoside" is also known in the art by the term
"isoacteoside." Ans. 2; see also Dal Monte ,-i 53. Dal Monte teaches
that the amount of isoacteoside in two exemplary extracts is about 8%
by weight (Extract 1) and 17% by weight (Extract 2). Dal Monte ,-i 72
(Table 2).
5. Dal Monte provides several examples showing the pharmacological
action of the extracts, pure verbacoside, and pure isoverbascoside. Id.
at ,-i 74. Dal Monte found that, in some cases, pure verbascoside and
isoverbascoside "exhibit pharmacological activities comparable to the
inventive extracts," namely, in "platelet aggregation, anti-
inflammatory and anti-lipoxygenase, anti-5alpha reductase, anti-
tyrosinase, antifungal and metal-chelating" activities. Id.; see also
Tables 4-9 and 11.
6. Dal Monte teaches that the therapeutic dose "varies, depending on the
patient[']s age, weight, sex and type of pathology, between 0.1 mg
and 2 g per day and preferably between 5 and 150 mg per day." Dal
Monte ,-i 132. In an exemplary embodiment, Dal Monte teaches a
500 mg extract. Id. at ,-i 135. The Examiner calculated that a 500 mg
extract comprises between 40 mg (i.e., 8% by weight) and 85 mg (i.e.,
17% by weight) of isoacteoside, "which would be more than sufficient
for treating a human weighing about 60 kg (i.e., .67 mg/kg and 1.42
mg/kg, respectively)." Ans. 8-9.
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LEGAL STANDARD
A claim is anticipated, and therefore unpatentable under 35 U.S.C.
§ 102, if all of its limitations are disclosed either explicitly or inherently in a
single prior art reference. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
1997). A claimed invention is unpatentable under 35 U.S.C. § 103 if the
differences between it and the prior art are "such that the subject matter as a
whole would have been obvious at the time the invention was made to a
person having ordinary skill in the art." 35 U.S.C. § 103(a) (pre-AIA). To
assess whether the subject matter would have been obvious, the Board
follows guidance in Graham v. John Deere Co., 383 U.S. 1 (1966) and KSR
Int'! Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
DISCUSSION
On appeal, the Board "reviews the obviousness rejection for error
based upon the issues identified by appellant, and in light of the arguments
and evidence produced thereon." Ex parte Frye, 94 USPQ2d 1072, 1075-76
(BP AI 2010) (Precedential). We address each issue raised by Appellants
below.
Anticipation
The Examiner found that Dal Monte anticipates claims 1 and 9
because Dal Monte teaches a method of treating an individual having
Alzheimer's disease with a plant extract containing a therapeutically-
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effective amount of isoacteoside. 3 Ans. 2. The Examiner also found that
Dal Monte's method of treatment would necessarily inhibit the "formation,
accumulation, or aggregation" of amyloid B peptides in the individual
treated. Ans. 2-3. For reasons discussed below, we find that the
preponderance of the evidence supports the Examiner's anticipation
rejection.
On appeal, Appellants first "point out" that Dal Monte's plant extract
contains many components of which isoacteoside is only a "minor
component." Appeal Br. 3--4. Although we acknowledge that some
examples of Dal Monte's plant extract contain isoacteoside in addition to
other components, FF4, we disagree with Appellants' assertion that Dal
Monte fails to teach an example containing only isoacteoside. We note that
Dal Monte also discloses several examples of pure isoacteoside that "exhibit
pharmacological activities comparable to the inventive extracts." FF5; see
also Ans. 6. Thus, Dal Monte's disclosure is not limited to extracts in which
isoacteoside is only a "minor component." See In re Bode, 550 F.2d 656,
661 ( CCP A 1977) (stating that a "reference must be evaluated for all it
teaches and is not limited to its specific embodiments").
Appellants then advance a theory that Dal Monte teaches a "genus"
(i.e., an extract containing isoacteoside among other compounds), but does
not teach the claimed "species" (i.e., isoacteoside ). Appeal Br. 4.
Appellants argue that the Examiner should have analyzed whether Dal
3 As noted above, the terms "isoacteoside" and "isoverbascoside"
refer to the same compound. FF4. For simplicity, we use the term
"isoacteoside" throughout the Discussion.
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Monte anticipates claims 1 and 9 under a genus-species framework. Id. at
3--4. Appellants also assert that the Federal Circuit's holding inAtofina v.
Great Lakes Chem. Corp., 441F.3d991 (Fed. Cir. 2006), governs the
outcome of this case because the use of isoacteoside (the species) is "critical
to utility," and Atofina holds that any species "critical to utility" is not
anticipated by earlier disclosure of a genus encompassing that species. Id. at
4-5.
On the facts of this case, we agree with the Examiner that a genus-
species analysis would not have been proper. See Ans. 9-10. Dal Monte
does not merely disclose a broad genus of extract components without
disclosing the particular claimed ingredient. Instead, Dal IV1onte specifically
discloses several examples of pure isoacteoside, and teaches that
administration of pure isoacteoside "exhibit[ s] pharmacological activities ...
[of] platelet aggregation, anti-inflammatory and anti-lipoxygenase, anti-
5alpha reductase, anti-tyrosinase, antifungal and metal-chelating." FF5;
Ans. 6. '"That specific disclosure ... makes this case different from cases
involving disclosure of a broad genus without reference to the potentially
anticipating species." Perricone v. Medicis Pharm. Corp., 432 F.3d 1368,
1377 (Fed. Cir. 2005).
But even if the question of anticipation in this case were analyzed
under the genus-species framework, Atofina would not help Appellants. The
claim at issue in Atofina recited a method of synthesizing difluoromethane at
a temperature between 330--450 degrees Celsius. 441 F.3d at 993. The prior
art disclosed a broad temperature range of 100-500 degrees Celsius. Id. at
999. The Federal Circuit found that '"no reasonable fact finder could
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conclude that the prior art describes the claimed range with sufficient
specificity to anticipate this limitation of the claim" because the range of
temperatures disclosed in the prior aii "was not a small genus." Id. Here,
again, even if Dal l\t1onte's extract is considered a "genus" of compounds,
Dal IV1onte also discloses the specific "species" claimed-isoacteoside. FF5;
Ans. 6, 9. Thus, unlike inAtqfina, no non-specific and broad range exists in
this case, and Appe11ants' assertions otherwise, Reply Br. 3, are not
persuasive.
vVe turn to Appellants' argument that the patentee's narrower
temperature range in Atofina was "'critical to utility" and therefore not
anticipated. Appeal Br. 4-5. vVe first observe that the outcmne inAtofina
appears to have been based on the size of the genus. 441 F .3d at 999. The
Atoflna decision does not mention a difference in utilitv between the broader ,, "'
temperature range and the narrower temperature range, nor does that
decision refer to or discuss the "'criticality" of the nanm.ver temperature
range. Id. 4 We acknowledge that in Clear Value, Inc. v. Pearl River
~ ~
P0Zvn1ers, Inc., 668 F.3d 1340, 1345 (Fed. Cir. 2012), the Court relied on
statements made during the prosecution history of the patent-at-issue in
Atofina (but not cited or discussed in that decision itself) to hold that a
method for "clarifying water with an alkalinity of 150 ppm or less"
4 The only reference to "criticality" in Atofina, instead, related to a
completely different issue: whether the proper construction of "'chromimn
catalyst" could include other metal components. Id. at 997. The Court held
that "chromium catalyst" excluded metal oxides and non-inert additives in
part because "applicants' disclosure in comparative examples 2 and 3
indicates the criticali~y of utilizing chromium catalyst alone rather than in
combination with other metal components." Id. (emphasis in original).
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anticipated a range of "'less than or equal to 50 ppm." Clearf;'alue, 668 F.3d
at 1344---45. The Federal Circuit held that the narrower alkalinity range was
anticipated, in part, because '"there [was] no allegation of criticality or any
evidence demonstrating any difference across the range." Id. at 1345.
Although we question whether Atqfina, based on its language and
analysis, stands for the proposition Appellants argue, see OSRAM Sylvania,
Inc. v. Am. Induction Techs., Inc., 701 F.3d 698, 705 (Fed. Cir. 2012)
(stating that "our decision in Clear Value does nothing to alter the
unequivocal statements in Atojzna"), vve note that the Federal Circuit has
attempted to reconcile the two cases. In OSR_Akl, the Court explained that a
proper genus-species analysis is premised on "[h ]ow one of ordinary skill in
the art would understand the scope of the disclosure or, stated differently,
how one of ordinary skill in the art would understand the relative size of
a genus or species in a particular technology." Id. at 706. This fact, the
Court held, "'is of critical importance." id. And here, as the Examiner
explained, a person having ordinary skill in the art would understand the
scope of Dal 11onte' s disclosure to include the sarne component and the
same method claimed. Ans. 9. In other words, because Dal IV1onte teaches
pure 1soacteoside that "exhibit[ s] pharmacological activities comparable to
the inventive extracts," FF5, a person having ordinary skill in the art would
understand Dal Monte as having disclosed the isoacteoside species. And as
Appellants have presented no evidence showing any difference between Dal
Yvionte's isoacteoside and the isoacteoside recited in Appellants' claims, we
therefore find unpersuasive Appellants' "critical to utility" argument
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Appellants argue next that Dal Monte does not anticipate because Dal
Monte's method of treatment relies on the extract's anti-oxidative activity,
rather than any ability of the extract to inhibit "formation, accumulation, or
aggregation of amyloid B peptides." Appeal Br. 4-5. But we agree with the
Examiner that, at most, Appellants have recognized that administering
isoacteoside inhibits the formation, accumulation, or aggregation of amyloid
B peptides. Ans. 11-13; see also FFl-2. As the Examiner explained, Dal
Monte teaches the broad method step of the claimed invention: the
administration of an effective amount of isoacteoside. Ans. 11-12.
Claiming the known method step as a method for inhibiting the formation,
accumulation, or aggregation of amyloid B peptides, as Appellants have
done here, does not change the fact that this inherent property (i.e.,
inhibiting the formation, accumulation, or aggregation of amyloid B
peptides) already existed in the prior art. See In re Cruciferous Sprout Litig.,
301 F.3d 1343, 1350 (Fed. Cir. 2002) ("It matters not that those of ordinary
skill heretofore may not have recognized these inherent characteristics of the
[prior art]."). Indeed, "[p]roducts of identical chemical composition can not
have mutually exclusive properties," In re Spada, 911 F.2d 705, 708 (Fed.
Cir. 1990).
For these reasons, we agree with the Examiner that claims 1 and 9 are
not patentable over Dal Monte. See Catalina Mktg. Int 'l, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 809-10 (Fed. Cir. 2002) (explaining
that an inventor may not obtain a patent on a process having the same steps
as a prior art process, in which the new process merely identifies a new,
advantageous property of the prior art process); Bristol-Myers Squibb Co. v.
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Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) ("Newly
discovered results of known processes directed to the same purpose are not
patentable because such results are inherent.").
Appellants argue that Dal Monte fails to even mention amyloid B
peptides and further state that "it is possible that the extract disclosed in Dal
Monte does not counteract amyloid B peptides at all." Appeal Br. 4-5
(emphasis added); see also Reply Br. 3 (reiterating that Dal Monte is silent
as to amyloid B peptides). We find that Appellants' arguments do not
sufficiently rebut the Examiner's finding of prima facie anticipation based
on inherency. An examiner meets the initial "burden of production by
adequately explaining the shortcomings [he] perceives so that the applicant
is properly notified and able to respond." In re Jung, 637 F.3d 1356, 1362
(Fed. Cir. 2011) (quotation omitted). The burden then shifts to the applicant
"to prove that the subject matter shown to be in the prior art does not possess
the characteristic relied on." In re Best, 562 F.2d 1252, 1254-55 (CCPA
1977).
Here, the Examiner adequately established a prima facie case of
anticipation based on inherency. As noted above, Dal Monte teaches the
same method step Appellants currently claim. Ans. 11-12. The only
difference between the claimed subject matter and Dal Monte is that Dal
Monte did not recognize that administration of isoacteoside inhibits the
formation, accumulation, or aggregation of amyloid B peptides. Id. But
again, the Examiner-by showing that the isoacteoside in Dal Monte is the
same as that used in the claimed invention and that Dal Monte teaches the
step of administering isoacteoside-set forth an adequate prima facie case
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that the recited property is necessarily present in Dal Monte's extracts. Ans.
11-13; see also FF 4-6. Appellants failed to provide evidence to the
contrary. Thus, the Examiner was correct in maintaining the rejection. Best,
562 F.2d at 1254-55.
In the alternative, Appellants argue that "[ e ]ven if the extract could
inhibit the formation, accumulation, or aggregation of amyloid B peptides,
its effective amount would have been very different from that of isoacteoside
or its salt required to practice the methods of claims 1 and 9." Appeal Br. 5.
We disagree. As the Examiner calculated, Dal Monte's suggested dosages
of isoacteoside (0.67 mg/kg and 1.42 mg/kg) lie within Appellants'
suggested "effective amounts" dosages (0.2 mg/kg to 4 mg/kg). FF2, 6.
Appellants do not dispute these calculations. See Appeal Br. 5; Reply Br. 3.
Thus, we agree with the Examiner that Dal Monte discloses an "effective
amount" of isoacteoside-i.e., an amount effective for inhibiting the
formation, accumulation, or aggregation of amyloid B peptides. FF2, 6.
Finally, Appellants argue that the Examiner's anticipation rejection
lacks support because Dal Monte "only teaches treating Alzheimer's disease
with an extract, not with purified isoacteoside." Appeal Br. 5. Accordingly,
Appellants argue, the fact that Dal Monte teaches purified isoacteoside is
irrelevant. Id. Again, we disagree.
The problem with Appellants' argument is that claims 1 and 9 are not
limited to "purified isoacteoside." Appeal Br. 9-10 (claims 1 and 9). Thus,
the claims encompass isoacteoside in any amount effective to inhibit the
formation, accumulation, or aggregation of amyloid B peptides. Ans. 6-9.
And, as noted above, the Examiner duly explained that Dal Monte discloses
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an "effective amount" of isoacteoside because Dal Monte's suggested
dosages of isoacteoside (0.67 mg/kg and 1.42 mg/kg) lie within Appellants'
suggested "effective amounts" dosages (0.2 mg/kg to 4 mg/kg). FF2, 6.
Moreover, the claims state that the method "compris[ es] administering to the
individual isoacteoside or a pharmaceutically acceptable salt thereof."
Appeal Br. 9-10 (claims 1 and 9). "' [C]omprising' does not exclude
ingredients not specifically mentioned in a claim." Swain v. Mallory, 329
F.2d 982, 987 (CCPA 1964).
Thus, we agree with the Examiner that claims 1 and 9 do not exclude
the co-administration of the other components of Dal Monte's extracts. Ans.
10. Put differently, even if Dal Monte's disclosure is limited to "an extract"
including isoacteoside for treating Alzheimer's disease, that extract reads on
claims 1 and 9.
Obviousness
Claim 8 depends from claim 1, and recites that "the isoacteoside or a
pharmaceutically acceptable salt thereof is administered to said individual in
a dosage equivalent to 0.2 mg-4.0 mg of isoacteoside or a pharmaceutically
acceptable salt thereof per kg of body weight per day." Appeal Br. 10
(claim 8). The Examiner rejected claim 8 because
it would have been prima facie obvious to one of ordinary skill
in the art at the time the invention was made to modify the
method of treatment taught by Dal Monte et al by optimizing
the dosage amount to 0.2 mg to 4.0 mg of isoacteoside per kg of
body weight per day because the claimed amount is within the
range taught by Dal Monte et al and Dal Monte et al teach that
the dosage amount is a result-effective variable for determining
optimum or workable ranges by routine experimentation based
on the individual's age, weight, sex and type of pathology, type
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of release form, and on the individual's therapeutic need over a
given period of time.
Ans. 5 (citing Dal Monte ,-i 132).
Appellants first argue that claim 8 would not have been obvious over
Dal Monte because claim 1 is not obvious over Dal Monte. Appeal Br. 6.
Appellants misapprehend the Examiner's rejection. The Examiner rejected
claim 1 based on inherent anticipation. Supra at 5-13. Claim 8 adds an
element missing from claim 1: "a dosage equivalent to 0.2 to 4.0 mg ... per
kg of body weight per day." Id. Thus, the issue before us is not whether a
method of treating a disease or condition associated with amyloid B peptides
would have been obvious, but whether the specific dosage recited in claim 8
would have been obvious.
And here, we find that the Examiner set forth an adequate prima facie
case of obviousness for claim 8. The "discovery of an optimum value of a
result effective variable in a known process is ordinarily within the skill of
the art," and suffices to establish "a prima facie case of obviousness." In re
Boesch, 617 F.2d 272, 276 (CCPA 1980). Here, the Examiner found, and
we agree, that Dal Monte recognizes that dosage is a result-effective variable
because Dal Monte teaches that the dosage may vary based on a particular
patient's age, weight, sex, and type of pathology. Ans. 5; FF6; see also In re
Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) ("A
recognition in the prior art that a property is affected by the variable is
sufficient to find the variable result-effective.").
Appellants do not attempt to rebut the Examiner's finding that dosage
is a result-effective variable. See Appeal Br. 8 (stating that claim 8 is not
obvious because claim 1 is not obvious). For example, Appellants submit no
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evidence that the claimed dosage range of 0.2 to 4.0 mg/kg is "critical" or
"produce[ s] a new and unexpected result" as compared to the prior art.
Applied Materials, 692 F.3d at 1297. There is "also no evidence that the
'variables interacted in an unpredictable or unexpected way,' which could
render the claims nonobvious." In re Urbanski, 809 F.3d 1237, 1242--43
(Fed. Cir. 2016) (quoting Applied Materials, 692 F.3d at 1298). Because
Appellants have failed to rebut the Examiner's prima facie case, we affirm
the Examiner's rejection of claim 8 for obviousness.
For completeness of the record, we briefly address Appellants'
arguments that Dal Monte "teaches away" from the use of isoacteoside as a
"stand-alone therapeutical agent," Appeal Br. 6, and that the Specification
shows "unexpected results" over the prior art, id. at 7. We find neither
argument persuasive for the same reasons articulated in the Examiner's
Answer, Ans. 14-21, which we adopt.
As to "teaching away," we further add that "[t]he prior art's mere
disclosure of more than one alternative does not constitute a teaching away
from any of these alternatives because such disclosure does not criticize,
discredit, or otherwise discourage the solution claimed .... " In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004). Here, even if Dal Monte's extracts
are "preferable" to pure isoacteoside, Dal Monte does not state or suggest
that isoacteoside "should not" or "cannot" be administered. In re Mouttet,
686 F.3d 1322 (Fed. Cir. 2012). Rather, Dal Monte teaches that, in some
cases, pure isoacteoside "exhibit[ s] pharmacological activities comparable to
the inventive extracts." FF5. Thus, Dal Monte does not teach away. See
Mouttet, 686 F.3d at 1334 (explaining that teaching one way does not
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amount to a teaching away from another, known way, even if the latter way
would have been somewhat inferior).
Finally, as to "unexpected results," we additionally note that none of
Appellants' examples show superior and unexpected results with respect to
the claimed dosage range of 0.2 to 4.0 mg per kg of body weight. "In
general, an applicant may overcome a prima facie case of obviousness by
establishing that the claimed range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior art range." In
re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) (quotation and alteration
omitted). But here, Appellants' examples do not show unexpected results
for any particular dosage. The experiments mostly test isoacteoside against
other compounds. See Spec. 8 (Example 2 (testing each sample compound
at a concentration of50 µg/ml)); Spec. 10 (Example 6 (same)).
And those tests providing two different dosage concentrations of
isoacteoside (i.e., 2.5 mg/kg and 5 mg/kg), see Spec. 13 (Table), do not
show that a dosage of 2.5 mg/kg is unexpectedly superior over a dosage of
5 mg/kg. In fact, those tests show the opposite. Specifically, Figure 8
(Example 7), Figure 9 (Example 8), and Figures 10-11 (Example 9) show
that the higher 5 mg/kg dosage of isoacteoside-which is outside the
claimed dosage range of 0.2 to 4.0 mg/kg-produced better results5 than the
lower dosage of isoacteoside, which is inside the claimed dosage range.
5 Specifically, rats given 5 mg/kg of isoacteoside showed improved
exploratory activities, improved passive-avoidance learning response, and
improved spatial performance over rats given 2.5 mg/kg of isoacteoside.
Spec. 12-15 (Examples 7-9).
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Spec. 12-15 (Examples 7-9). Thus, Appellants' allegations of unexpected
results are unavailing.
SUMMARY
We affirm the rejections of claims 1-12 on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED
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