Ex Parte 7,094,427 B2 et al

Patent Trial and Appeal Board

Sep 23, 2016

90012293 (P.T.A.B. Sep. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
90/012,293 06/15/2012
96056 7590
Florek & Endres PLLC
1156 A venue of the Americas
Suite 600
New York, NY 10036
09/26/2016
FIRST NAMED INVENTOR
7,094,427 B2
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.
5160-8001 7767
EXAMINER
TURNER, SHARON L
ART UNIT PAPER NUMBER
3991
MAILDATE DELIVERY MODE
09/26/2016 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
IMP AX LABORATORIES
Patent Owner and Appellant
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Technology Center 3900
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
RAEL YNN P. GUEST, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal by Patent Owner from the Patent
Examiner's final rejection of claims 1-13 and 17-33 in the above-identified
ex parte reexamination of U.S. Pat. No. 7,094,427 Bl. The Board's
jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134(b), and 306. We
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affirm-in-part, reverse-in-part, and set forth a new ground of rejection of
claim 2 pursuant to 37 C.F.R. § 41.50(b).
STATEMENT OF CASE
This appeal involves U.S. Pat. No. 7,094,427 Bl ("the '427 patent")
which was issued Aug. 26, 2006. A Request for Ex Parte Reexamination of
the '427 patent was submitted by a third-party requester on Jun. 15, 2012.
Claims 1-13 and 17-33 are pending and stand rejected by the
Examiner. Final Rejection ("Final Rej." (dated Jul. 25, 2014). Claims 1-13
and 17-31 are original claims which were amended during the
reexamination proceeding. Claims 3 2 and 3 3 were added during the
reexamination proceeding.
The real party in interest in this ex parte reexamination is Impax
Laboratories, Inc., who is the Patent Owner. Appeal Br. 3 (Jan. 26, 2015.)
An oral hearing was held June 1, 2016. A transcript of the hearing
will be entered into the record in due course.
The claims in the '427 patent are directed to a pharmaceutical dosage
form having an immediate release component and a controlled release
component. Each component comprises carbidopa and levodopa. The '427
patent teaches that the dosage form can be used to treat conditions
characterized by reduced levels of dopamine in a patient's brain, including
conditions such as neurological or movement disorders, Parkinson's disease,
secondary parkinsonism, Huntington's disease, Shy-Drager syndrome, and
conditions resulting from brain injury, such as carbon monoxide or
manganese intoxication. '427 patent, col. 3, 11. 26-32.
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Claim 1 is the only independent claim on appeal. The claim is
reproduced below (underlining and brackets show amendments relative to
the original claim):
1. A pharmaceutical dosage form having an immediate release
component and a controlled release component comprising:
a) an immediate release component comprising a ratio of
carbidopa to levodopa of from about 1: 1 to about 1 :50 such that
the in vitro dissolution rate of the immediate release component
according to measurements under the USP paddle method of 50
rpm in 900 ml aqueous buffer at pH 4 at 37° C[.] is from about
10% to about 99% levodopa released after 15 minutes and from
about 60% to about 99% after 1 hour; and
b) a controlled release component comprising a ratio of
carbidopa to levodopa of from about 1: 1 to about 1 :50 such that
the in vitro dissolution rate of the controlled release component
according to measurements under the USP paddle method of 50
rpm in 900 ml aqueous buffer at pH 4 at 37° C[.] is from about
10% to about 60% levodopa released after 1 hour; from about
20% to about 80% levodopa released after 2 hours; and from
about 30% to about 99% levodopa released after about 6 hours,
the in vitro release rate chosen such that the initial peak plasma
level of levodopa obtained in vivo occurs between 0.1 and 6
hours after administration of the dosage form to a patient[.].,_
wherein the controlled release component comprises controlled
release particles or granules; and wherein the carbidopa and
levodopa are combined in the controlled release particles or
granules.
The claims stand finally rejected by the Examiner as follows:
1. Claims 1-13 and 17-33 1 under35 U.S.C. § 102(e) (pre-AIA) as
anticipated by, or in the alternative, under 35 U.S.C. § 103(a) as obvious
1 The Examiner included claims 14--16, but these claims were cancelled.
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over, Licht et al., U.S. Patent Application Publication No. 2003/0147957 Al
("Licht"), published Aug. 7, 2003. Final Rej'n 6.
2. Claims 1, 3-13, and 17-33 under 35 U.S.C. § 102(b) (pre-AIA) as
anticipated by Rubin, WO 00/15197 ("Rubin"), published Mar. 23, 2000, as
evidenced by the declaration under 37 C.F.R. § 1.132 of Chien-Hsuan Han,
Ph.D. ("Han Deel."). The Han Declaration was originally filed Nov. 11,
2004, in Application Serial No. 10/241,837 which matured into the '427
patent. Final Rej. 14.
3. Claims 1, 3-13, and 17-33 under 35 U.S.C. § 103(a) as obvious in
view of Rubin, Licht, and the evidence of the Han Declaration. Final Rej.
14.
1. REJECTIONS BASED ON LICHT ALONE
Claim 1 is directed to a pharmaceutical dosage having immediate
release and controlled release components. The controlled release
component "comprises controlled release particles or granules; and wherein
the carbidopa and levodopa are combined in the controlled release particles
or granules." The Examiner interpreted the claim to require that both the
carbidopa and levodopa are in the granulate or particulate form. 2 In other
words, a granule includes both levodopa and carbidopa components, e.g., the
components are mixed prior to being granulated, as distinguished from a
2 The claim requires the carbidopa and levodopa to be combined in
"particles or granules." Particles are defined in the '427 patent as granules
of a particular size: "The term particle as used herein means a granule
having a diameter of between about 0.01 mm and about 5.0 mm, preferably
between about 0.1 mm and about 2.5 mm, and more preferably between
about 0.5 mm and about 2 mm." '427 patent, col. 9, 11. 45--48. Therefore,
for the purpose of the claims of the '427 patent, "particles" are granules.
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mixture of granules of only levodopa and granules of only carbidopa. Patent
Owner does not dispute the Examiner's interpretation.
The Examiner found that Licht describes "a mixture of a granulated
admixture of a decarboxylase inhibitor ( carbidopa) and levodopa ethyl ester
or a derivative or a pharmaceutically acceptable salt thereof, Licht Title,
Abstract, Tables 2-13, 16-17 and 19-20." Final Rej. 7. The Examiner stated
that the Licht formulation comprising carbidopa and levodopa was "made
via art recognized granulation methods including mixing or blending the
components together in a granulated admixture" and thus is a "granule" as
required by the claim. Id. at 7-8. The Examiner cited Examples 1-7 to
support this statement. Id. at 8. The Examiner also found that the particles
described in Licht "conform to the requisite particle or granule size i-f 83,
Table 18." Id.
The Examiner's findings are not supported by a preponderance of the
evidence. The abstract and summary of the invention in Licht describe "(a)
a granulated admixture of a decarboxylase inhibitor and a surfactant," and
"(b) levodopa ethyl ester or a derivative or a pharmaceutically acceptable
salt thereof." Licht, Abstract, i1i123 and 24. The decarboxylase inhibitor,
which can be carbidopa (id. at i1i14 and 28), is expressly disclosed as being
in the granulated form (id. at "a"), but the levodopa ethyl ester is not (id. at
"b").
Tables 2 and 4 of Licht show a "Composition of carbidopa
monohydrate granulate" in which carbidopa is present, but not levodopa. Id.
at p. 9, i-fi-f 186 and 190. Paragraph 187, which follows Table 2, states that
the "carbidopa monohydrate granulate was then mixed with LDEE
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[levodopa ethyl ester], a carrier and several excipients (Table 3)." Tables 3
and 5 refer to "Granulate carbidopa monohydrate" and L-dopa ethyl ester.
Id. at i-fi-f 187 and 191. None of these disclosures describe the levodopa as a
granulate or as present in the granulated carbidopa. See also id. at i-fi-128, 35,
40, 47, and 58 (each characterizing carbidopa as a granulate). Thus, there is
no express support for the Examiner's finding that the levodopa is combined
with the carbidopa as a granule.
Licht describes mixing the carbidopa granulate with the levodopa. Id.
at i-fi-f 142, 148, 187. Licht describes the result of the mixing as a "mixture,"
not as a granulate. Id. at i-f 188. The Examiner states that mixing as
described by Licht would result in a granule (Final Rej. 7-8), but this
statement is conclusory and is not supported by factual evidence.
Specifically, the Examiner did not provide evidence that the mixing
procedure in Licht would necessarily result in carbidopa and levodopa
"combined in the controlled release ... granules" as required by the claim.
The Examiner stated that the "subsequent mixing process is also consistent
with art recognized granulating procedures and thus does not distinguish the
resulting granulated admixture from being in granule or particle form," but
the Examiner did not establish that the procedure described by Licht is an
"art recognized granulating procedure." Answer 8. For example, the '427
patent describes several specific methods for performing granulation (' 427
patent, col. 8, 1. 47 to col. 9, 1. 6), but the Examiner did not show that the
mixing described in Licht corresponds to any of these methods. See also
Appeal Br. 15 ("[T]he skilled artisan understands that controlled release
particles or granules are not prepared by the mere mixing or blending of
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ingredients. This understanding is confirmed by Licht wherein the carbidopa
granulate is prepared by a wet granulation technique and appropriately
identified as granules while the blend of carbidopa granules, excipients and
levodopa ethyl ester is identified as a mixture.").
The Examiner also pointed to the particle size shown in Table 18 as
evidence that Licht's mixture of carbidopa and levodopa forms a granule.
Final Rej. 8. However, the particles in Table 18 represent only the particle
size of levodopa. Licht, i-f 211 ("Particle size distribution of LDEE in inner
cores Y and Z"). Unlike the '427 patent where "particle" is defined as a
"granule," there is no evidence that Licht utilized the term "particle" with
respect to levodopa to mean a granulated form of levodopa. There is also no
evidence that the particle size described in this table is the levodopa and
carbidopa mixed together to form a granule, or levodopa as a granule alone.
See Reply Br. 6.
The Examiner also rejected the claims as obvious in view of Licht.
However, the Examiner did not explain why it would have been obvious to
have formulated granules that contain both carbidopa and levodopa, as
required by the claim.
For the foregoing reasons, we reverse the anticipation and
obviousness rejections of independent claim 1 and dependent claims 2-13
and 17-33 based on Licht.
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2. ANTICIPATION BASED ON RUBIN
Rejection
The pharmaceutical dosage form of claim 1 recites specific
dissolution rates for the levodopa in the immediate release and controlled
release components. In addition, as already discussed, the controlled release
component comprises "controlled release particles or granules; and wherein
the carbidopa and levodopa are combined in the controlled release particles
or granules." The Examiner found Rubin describes a granule with carbidopa
and levodopa and that the resulting dosage form inherently possesses the
claimed dissolution rates for levodopa. Final Rej 'n 14--16. The Examiner
relied upon the Han declaration to establish that Rubin's formation
inherently exhibited the same dissolution rates for levodopa recited in claim
1. Id.
Example 3 of Rubin describes forming core pellets comprising
micronized carbidopa and levodopa using a fluid-bed with a Wurster air
suspension coating column. Rubin 5:10-12. The Examiner found that
Rubin's procedure is consistent with the fluid bed granulation procedure
disclosed in the '427 patent, providing evidence that Rubin describes the
claimed controlled release granules in which "the carbidopa and levodopa
are combined." Final Rej. 15. Patent Owner did not identify an error in the
Examiner's finding that Rubin teaches a granulated mixture of levodopa and
carbidopa. Because the finding is supported by a preponderance of the
evidence, we conclude that granule limitation claim 1 is met by Rubin.
Claim 1 also requires a specific dissolution rate profile of levodopa in
which the drugs are released from the immediate and controlled release
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components over specific recited periods of time in specific amounts, e.g.,
"from about 10% to about 60% levodopa released after 1 hour; from about
20% to about 80% levodopa released after 2 hours; and from about 30% to
about 99% levodopa released after about 6 hour" from the controlled release
component. However, as acknowledged by the Examiner, Rubin is silent as
to these specific values. Id. However, the Examiner found that Rubin
disclosed:
The conventional immediate release combination of
carbidopa-levodopa reaches peak plasma concentrations
in 30 minutes whereas the onset of the controlled release
component is two hours followed by prolonged release
over a four- to six-hour period.
Rubin 3:5-9.
Based on this disclosure and the similarities in dosage range, the
Examiner found that "the peak plasma level and similarities in dosage range
and form [disclosed by Rubin] strongly suggest the dissolution profile
claimed." Final Rej. 15. As further evidence, the Examiner relied upon the
declaration by Dr. Han that "tablets made in accordance with Rubin '699
Example 2, [show that] a significant proportion of the samples of both the
immediate release and controlled release components meet the dissolution
profile claimed." Id. (emphasis added.)
Example 2 of Rubin does not disclose that the carbidopa and levodopa
are combined in a granule. Instead, the rejection relies on Rubin's Example
3, which discloses both compounds formulated in a granule. Patent Owner
admits that "[d]ue to the similar nature of the amount of active ingredients in
Example 2 and Example 3, a skilled artisan would reasonably assume that
the in vitro dissolution data for Example 3 would be similar to that of
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Example 2." Appeal Br. 24. Thus, by Patent Owner's admission, to the
extent that the Han declaration evidence represents dissolution profiles
inherent in Rubin's Example 2, such data similarly applies to Example 3.
We thus tum to the Han declaration.
Han declaration
Dr. Han stated in the § 1.132 declaration that "I was not able to
prepare a tablet according to Example 2 in U.S. Patent No. 6,238,699 to
Rubin." Han Deel. i-f 3. Dr. Han based this statement on the following
evidence:
Id.
I considered repeating the procedures described in the present
tense in Example 2. The Example 2 in U.S. Patent No. 6,238,699
to Rubin does not describe suitable manufacturing conditions
such as tooling or hardness. Furthermore, the one-sentence
instructions say to prepare the blend as described and compress
into tablets using a "suitable layered press." While trying to
follow the one-sentence instructions, a resulting blend was
obtained, and when that blend was introduced into a conventional
hopper, it had such poor flow quality that I could not make tablets
using a suitable layered press (a Stokes Press).
Dr. Han stated:
4. I had to abandon the effort to apply a "suitable
layering press" according to the one sentence process
description in said Example 2 in U.S. Patent No.
6,238,699 to Rubin. Instead, I tried to make individual
tablets by hand, i.e. compressing ingredients to obtain
individual tablet dosage forms.
Id. at i-f 4.
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The resulting dissolution data reported by Dr. Han in the declaration
was obtained by hand tab letting. On pages 22-23 of the Appeal Brief,
Patent Owner summarized Dr. Han's data in a table. All references to the
data is with respect to this table.
Discussion
Claim 1 requires a specific dissolution rate profile of levodopa in
which the drugs are released from the immediate and controlled release
components over specific recited periods of time in specific amounts. Rubin
was considered by the Examiner to be anticipatory to the claimed subject
matter because, while Rubin did not describe the dissolution characteristics
of the levodopa in its tablets, the Han declaration data was found by the
Examiner to establish that Rubin's formulation would have the same
dissolution characteristics as claimed. In other words, the tablet described in
Example 3 of Rubin would "inherently" have the dissolution characteristics
recited in the claim. A "prior art reference may anticipate without disclosing
a feature of the claimed invention if that missing characteristic is necessarily
present, or inherent, in the single anticipating reference." SmithKline
Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005).
When inherency is a basis of anticipation, it "may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient." In re Robertson, 169
F.3d 743, 745 (Fed. Cir. 1999) (internal citation and quotation marks
omitted).
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Dr. Han described the results from tablets comprising levodopa and
carbidopa having different hardnesses and dimensions. Dr. Han's data
shows that the hardness and dimension of the tablet affected the in vitro
release rate. Appeal Br. 23. For example, for the two hour dissolution
period, none of the tablets of four different hardnesses met the "about 20%
to about 80%" claim limitation for the tablet having a dimension of 0.2750 x
0.5100. Id. For the tablet of a dimension of 0.2500 x 0.4375, only two of
the four different hardnesses (Hardnesses 11 and 2) were close to the "about
20% to about 80%" claim limitation. Id.
Because of these deficiencies in Rubin, the evidence does not support
a finding that Rubin would necessarily result in a pharmaceutical dosage
form with a controlled release component with the release profile required
by claim. Robertson, 169 F.3d at 745. The claimed release profile is not
necessarily present in Rubin because Rubin does not disclose the tablet size
nor hardness, and Han's data indicates that, not only do such variables affect
the dissolution profile, but not all conditions resulted in the claimed
dissolution profile. See Appeal Br. 22-23. For this reason, we are
compelled to reverse the anticipation rejection based on Rubin of claims 1,
3-13, and 17-33.
OBVIOUSNESS BASED ON RUBIN AND LICHT
Rejection
The Examiner rejected claims 1, 3-13, and 17-33 as obvious in view
of Rubin, Licht, and the evidence in the Han declaration. Final Rej. 14.
The Examiner found that Rubin describes a pharmaceutical dosage
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form with an immediate release outer layer and controlled release inner
layer, each containing carbidopa and levodopa within the ratio and amounts
recited in claim 1. Id. at 14 and 16. The Examiner also found that Example
3 of Rubin describes forming core pellets comprising carbidopa and
levodopa using a fluid-bed with air suspension coating column, consistent
with the fluid bed granulation method described in the '427 patent to make
granules as required by the claims. Id. at 14--15. The Examiner
acknowledged that Rubin does not describe the specific dissolution rate
profile in claim 1, but found that the peak plasma levels and dosage ranges
[described in Rubin] suggested the levodopa dissolution profile of claim 1.
Id. at 15. The Examiner found that the data in the Han declaration
confirmed that Rubin's dosage form possessed the dissolution profile of
claim 1. Id.
The Examiner also found that Licht describes the claimed dissolution
profile for carbidopa and levodopa, motivating the skilled worker to have
made a dosage form with such dissolution properties as claimed. Id. at 19--
20.
Patent Owner contends that the Examiner erred. Patent Owner
argues:
levodopa ethyl ester [LDEE] [as described in Licht] is 300 to
400 times more soluble than levodopa [as described in Rubin].
Based upon this great disparity in solubility, Licht instructs a
skilled artisan not to substitute levodopa ethyl ester for
levodopa in the formulations of Rubin. Licht, i-f [0175].
Therefore, if a skilled artisan were to combine Rubin and Licht,
the skilled artisan would not expect to obtain similar in vitro
release profiles as taught in Licht because Licht employs the
much more soluble form of levodopa.
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Appeal Br. 25.
Patent Owner also argues that Licht does not describe controlled
release granules comprising levodopa and carbidopa. Reply Br. 7.
Discussion
Patent Owner's contention that the skilled worker would not have
combined Rubin and Licht to have achieved the recited dissolution profile is
not supported by the preponderance of the evidence before us.
To begin with, Patent Owner did not demonstrate error in the
Examiner's finding the Licht describes a dissolution profile that meets or
overlaps with the corresponding claimed limitations. For example, Table 15
(Licht i-fi-1206-207) shows that, after 15 mins, 94% of LDEE had been
released as required by the immediate release component of claim 1 ("about
10% to about 99% levodopa released after 15 minutes"). The controlled
release component described by Licht also possesses a dissolution profile of
LDEE as claimed. See Licht, Table 7 (see inner cores C-F showing LDEE
release "from about 10% to about 60% ... after 1 hour; "from about 20% to
about 80% ... released after 2 hours"), Table 9 (see inner core G showing
LDEE release "from about 10% to about 60% ... after 1 hour; "from about
20% to about 80% ... released after 2 hours"; "from about 30% to about
99% ... after about 6 hours; inner cores H and I showing "from about 10%
to about 60% ... after 1 hour; "from about 20% to about 80% ... released
after 2 hours"), Table 11 (see inner cores N and P showing LDEE release
"from about 10% to about 60% ... after 1 hour; "from about 20% to about
80% ... released after 2 hours"), and Table 13 (see inner cores S-U showing
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LDEE release "from about 10% to about 60% levodopa released after 1
hour; from about 20% to about 80% levodopa released after 2 hours").
As found by the Examiner, the skilled worker would have had chosen
the dissolution profile of Licht, when utilizing levodopa as in Rubin,
because the profile is described by Licht as optimal to achieve effective
levodopa levels. Id. at i-fi-f 195, 198, 201.
Specifically, Licht states that:
In a solid formulation, it is important that the rate of
dissolution, and hence, the blood level, of the decarboxylase
inhibitor be appropriate for that of the L-DOPA in both the
immediate release and the slow release formulations of
carbidopa and L-DOPA, these two active ingredients are
released at the same ratio .... [T]he chemical and physical
properties of carbidopa and levodopa are similar. ... Release
characteristics depend on the geometry of the system, the nature
of the polymer [carrier] and other excipients, solubility and the
processing methods. . . . [I]t was found that the in vitro release
is a direct fi1nction of their solubility in the dissolution fluid.
Both compounds are slightly soluble in water, degrade rapidly
in alkaline media, and have similar solubility versus pH
profiles, as well as similar solubility versus temperature
profiles.
Licht i-f 168.
Rubin contains a similar teaching:
The strategy proposed in the present invention is to
formulate oral dosage forms containing both immediate
release carbidopa-levodopa and controlled release
carbidopa-levodopa. Ingestion would provide rapid onset
antiparkinson activity via the immediate release
component followed by sustained therapeutic activity
from the controlled release component.
Rubin 2: 23-29.
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Further, the timing for desirable peak plasma concentrations sought in
Rubin, which are consistent with the timing for achieving peak plasma
concentrations recited in the claim 1, are also consistent with the dissolution
profiles taught by Licht. Rubin states:
The conventional immediate release combination of
carbidopa-levodopa reaches peak plasma concentrations
in 30 minutes whereas the onset of the controlled release
component is two hours followed by prolonged release
over a four- to six-hour period.
Id. at 3:5-9 (emphasis added). Indeed, the claim requires the release rate to
achieve "the initial peak plasma level of levodopa obtained in vivo occurs
between 0.1 and 6 hours after administration of the dosage form to a
patient." (Emphasis added.)
Licht describes levodopa ethyl ester ("LDEE") in its tablet. Licht
i-f 18. Rubin, however, uses the less soluble levodopa ("L-DOPA"). Rubin,
Abstract. Patent Owner states that the skilled worker would not have
expected to achieve the same release profile described by Licht in Rubin's
formulation because Licht employs a more soluble form of levodopa than
the form utilized by Rubin. Appeal Br. 25.
This argument is not persuasive. The data in Dr. Han's declaration
expressly demonstrates that dissolution rates within, and close to, the scope
of claim 1 can be achieved with levodopa. Id. at 22-23. Thus, Patent
Owner's argument that the disparities in solubility between levodopa and
LDEE would have led to a lack of an expectation of success is not supported
factually because, although LDEE and levodopa are said to have different
solubilities, Dr. Han's declaration demonstrates that releases rates of
levodopa can be achieved which are close to those disclosed in Licht using
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LDEE. See Answer 18. Patent Owner did not identify an error in the
Examiner's reasoning nor explain how the differences in solubility would
have led to a lack of a reasonable expectation of success when the Han
declaration, and the similarities in peak plsma levels in Rubin (at 3: 5-9)
provide evidence to the contrary. An argument made by counsel in a brief
does not substitute for evidence lacking in the record. Estee Lauder, Inc. v.
L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997).
Patent Owner's argument that the skilled worker would not have had
reason to substitute levodopa for LDEE (Appeal Br. 18 and 25 (argument for
claim 32)) is misplaced because the rejection is based on Rubin's drug
combination, which has both levodopa and carbidopa as claimed. The
Examiner did not propose substituting levodopa for LDEE in Licht's dosage
form. Rather, the Examiner found that the skilled worker would have had a
reason to adopt Licht's dissolution profile for Rubin's tablet. Final Rej. 19-
20.
For the foregoing reasons, we affirm the rejection of claims 1 and 32
as obvious in view of Rubin, Licht, and the evidence in the Han declaration.
Claims 3-13, and 17-33 were not argued separately and fall with claim 1.
CLAIM2
Claim 2 was not rejected as obvious in view of Rubin, Licht, and the
evidence in the Han declaration. Patent Owner compared the release rates
recited in claims 1 and 2 ("IR" is immediate release component; "CR" is
controlled release component):
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~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~,
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