Ex Parte Gorissen

Board of Patent Appeals and Interferences

Sep 22, 2010

10915560 (B.P.A.I. Sep. 22, 2010)

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.
10/915,560 08/11/2004 Henricus R.M. Gorissen 011091.55125US 7672
23911 7590 09/23/2010
CROWELL & MORING LLP
INTELLECTUAL PROPERTY GROUP
P.O. BOX 14300
WASHINGTON, DC 20044-4300
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
09/23/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HENRICUS R.M. GORISSEN
__________

Appeal 2010-004604
Application 10/915,560
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to an oral
formulation. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
Claims 1, 2, 4-10, 13, and 14 are on appeal (App. Br. 2).2 The claims
subject to each rejection have not been argued separately and therefore stand
or fall together. 37 C.F.R. § 41.37(c)(1)(vii). We will focus on claim 1,
which reads as follows:
1. An oral immediate release formulation of a poorly water-soluble
biologically active substance with enhanced bio-availability, wherein said
formulation is a homogeneous and thermodynamically stable solid solution
comprising as a percentage of the total weight of the formulation:
a) up to 50% by weight of the calcium salt of 3-[[[1-[2-(ethoxycarbonyl)-
4-phenylbutyl]-cyclopentyl]carbonyl]-amino]-2,3,4,5-tetrahydro-2-oxo-
1H-1-benzazepine-1-acetic acid as an active substance;
b) from 20 to 70% by weight of a non-ionic hydrophilic surfactant which is
liquid between 15 and 30°C; and
c) from 5 to 70% by weight of a pharmaceutically acceptable organic
polymer or polymer mixture which is liquid above 60°C and solid below
30°C.
The Specification is objected to for including new matter (Ans. 3).
However, the Specification objection does not impact any of the pending
rejections. Therefore, this matter is petitionable and we decline to exercise
our discretion to decide it. MPEP § 2163.06.
Claims 1, 2, 4-9, 13, and 14 stand rejected under 35 U.S.C. § 103(a)
as obvious over Rozsa et al. (US 5,783,573, Jul. 21, 1998) in view of Kelm
et al. (US 5,281,420, Jan. 25, 1994) (Ans. 5).
Claims 1, 2, 4-10, 13, and 14 stand rejected under 35 U.S.C. § 103(a)
as obvious over Rozsa in view of Kelm and Ghebre-Sellassie et al.
(WO 93/11749 A1, Jun. 24, 1993) (Ans. 9).

2 Claims 15-18 are also pending but have been withdrawn from
consideration by the Examiner (App. Br. 2).
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Claims 1, 4-10, 13, and 14 stand rejected under 35 U.S.C. § 103(a) as
obvious over Rozsa in view of Singh et al. (US 6,008,191, Dec. 28, 1999)
and Lambert et al. (WO 00/71163 A1, Nov. 30, 2000) (Ans. 10).
Claim 2 stands rejected under 35 U.S.C. § 103(a) as obvious over
Rozsa in view of Singh, Lambert, and Pformulate (Excipients: What Is A
Disintegrant?, http://web.archive.org/web/20010223063316/-
http://www.pformulate.com/disintegrs.htm, available 2/2001, printed
2/17/2008) (Ans. 13).
I
With regard to the rejections over Rozsa and Kelm, alone or in view
of Ghebre-Sellassie, the Examiner relies on Rozsa for teaching a class of
compounds including the specific example of 3-[[[1-[2-(ethoxy-carbonyl)-
4-phenylbutyl]-cyclopentyl]carbonyl]-amino]-2,3,4,5-tetrahydro-2-oxo-1H-
1-benzazepine-1-acetic acid, “how to form their salts and the use of the
compounds as pharmaceutical compositions as tablets, capsules, solutions,
or suppositories” (Ans. 5-6). The Examiner finds that “Rozsa states that the
compositions can be prepared by the known and customary methods of the
art including the use of solid and liquid carriers, solublizing agents, and
disintegrants” (id. at 6).
The Examiner relies on Kelm for teaching “a formulation for solid
dispersion of a water insoluble drug, tebufelone,” comprising “the drug,
surfactants such as poloxamers and polysorbate (or polyoxyethylene castor
oil derivates), and PEG” (id. at 7). The Examiner finds:
The ranges for the drug are from about 15% to about 75%, the
poloxamer at about 25% to about 65%, the polysorbates are
from 0% to about 60% with a preferable range of about 20% to
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about 40%, and the PEG is from 0% to about 60% with a
preferable range of about 20% to about 40%.
(Id.) The Examiner also finds that the “polysorbates taught are Tween 20®,
Tween 40®, Tween 60®, and Tween 80® which fulfills the claimed
surfactant properties” and the “PEGs preferred and claimed are with
molecular weights from about 3000 Daltons to about 8000 which fulfills the
polymer recitations” (id.). The Examiner concludes that it would have been
obvious “to utilize the formulation for delivery of a water-insoluble drug, as
suggested by Kelm, and produce the instant invention” (id. at 8).
The Examiner relies on Ghebre-Sellassie for teaching “that polyvinyl
pyrrolidone[, as recited in claim 10,] and PEG, particularly high molecular
weight PEGs are analogous” (id. at 9). The Examiner concludes that it
would have been obvious “to use PVP for PEG” (id.).
Issue
Does the evidence support the Examiner’s conclusion that it would
have been obvious to include a calcium salt of Rozsa’s compound in Kelm’s
carrier composition to form a solid solution?
Findings of Fact
1. The Specification states:
Various active substances have a very poor solubility in water.
When these active substances are administered to the body, they
often have a poor bio-availability due to their poor solubility in
the digestive fluid. In order to solve this problem several
methods have been developed, such as micronization, inclusion
in cyclodextrines, the use of inert water-soluble carriers, the use
of solid dispersions (WO 00/00179), or nanocrystalline or
amorphous forms of active substances.
(Spec. 1.)
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2. The Specification also states that the invention “relates to a
solid solution formulation . . . of a poorly water soluble compound of
formula I. . . . The preferred compound is the calcium salt of 1H-
1-Benzazepine-l-acetic acid, 3-[[[1-[2-(ethoxycarbonyl)-4- phenylbutyl]-
cyclopentyl]carbonyl]amino]-2,3,4,5-tetrahydro-2-oxo-.” (Id. at 6.)
3. The Specification discloses:
The formulation . . . can be prepared using conventional
formulation procedures and equipment. Therefore it is another
aspect of the present invention to provide a method of preparing
a formulation as described above, in which a) the non-ionic
hydrophilic surfactant is mixed with the pharmaceutically
acceptable organic polymer or mixture of polymers at between
50- 100 °C, preferably between 60 and 70°C, b) the active
ingredient is added and dissolved at said temperature, c) the
resulting mixture is optionally filled into a capsule, and d) the
resulting mixture is solidified at room temperature.
Alternatively the non-ionic hydrophilic surfactant, the
pharmaceutically acceptable organic polymer or mixture of
polymers and the active substances are mixed together and
heated to a temperature of between 50 and 100 °C, preferably
between 60 and 70 °C, until a clear solution is obtained,
optionally followed by filling the solution into a capsule.
(Id. at 6.)
4. Rozsa discloses compounds of general formula I and
physiologically acceptable salts thereof “for preparing pharmaceutical
compositions for the treatment and/or prophylaxis of gastrointestinal blood
circulation disturbances” (Rozsa, Abstract).
5. Rozsa also discloses:
[T]he compounds of the formula I can be included, together
with customary pharmaceutical auxiliary substances, in
pharmaceutical compositions such as tablets, capsules,
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suppositories or solutions. These pharmaceutical compositions
can be prepared by methods which are known per se using
customary solid or liquid carrier substances such as lactose,
starch or talc or liquid paraffins, and/or using customary
pharmaceutical auxiliary substances, for example tablet
disintegrants, solubilizing agents or preservatives.
(Id. at col. 4, ll. 17-25.)
6. In particular, Rozsa discloses tablets that comprise (3S,2'R)-
3-{1-[2'-(ethoxycarbonyl)-4-phenylbutyl]cyclopentane-1-carbonylamino}-
2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid (id. at col. 12,
ll. 64-67).
7. Kelm discloses:
compositions in dosage form comprising a solid dispersion
which is a solidified melt mixture consisting essentially of the
following components:
(a) from about 15% to about 75% of tebufelone;
(b) from about 25% to about 65% of a poloxamer
surfactant having a melting point of about 40° C. or greater . . .
; and
(c) from 0% to about 60% of other components,
wherein the other components are miscible with a melt mixture
of components (a) and (b).
(Kelm, col. 1, ll. 35-51.)
8. Kelm states:
As used herein, “solid dispersion” means a material which is
solid at specified temperatures, and which has been produced
by blending melted tebufelone and poloxamer (and other
components, if present), whereby a homogeneous melt mixture
results, and cooling the resulting melt mixture so that it forms a
solid with the components substantially uniformly dispersed
therein.
(Id. at col. 2, ll. 7-14.)
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9. Kelm also discloses:
It has been found that tebufelone is essentially water-insoluble
(solubility less than 1 µg/ml) and very lipophilic. . . . It has been
found that the absorption of tebufelone from the gastrointestinal
tract is quite low when the active is dosed in conventional
dosage forms, where solid particles of substantially pure
tebufelone are mixed with other solid excipients and filled into
hard gelatin capsules or compressed into tablets. It has been
found that good absorption of tebufelone from the
gastrointestinal tract occurs only when the drug active is
perorally administered in pharmaceutical compositions which
provide rapid solubilization of the drug active in the
gastrointestinal fluids. . . . It has been found that rapid
solubilization of tebufelone in gastrointestinal fluids can be
achieved from the compositions of the subject invention which
comprise solid dispersions comprising tebufelone with certain
poloxamer surfactants.
(Id. at col. 2, ll. 20-50.)
10. In addition, Kelm discloses that “[e]xamples of other
components which are suitable for incorporation in the solid dispersions of
the subject invention include other surfactants, and certain low molecular
weight water-soluble materials” (id. at col. 3, ll. 55-58).
11. In particular, Kelm discloses that “[p]referred other surfactants
include polysorbates,” which “are included in the solid dispersions of the
subject invention at levels of from 0% to about 60%, preferably from about
20% to about 40%,” and that preferred polysorbates include Polysorbate 20
(Tween 20®), Polysorbate 40 (Tween 40®), Polysorbate 60 (Tween 60®),
and Polysorbate 80 (Tween 80®) (id. at col. 3, l. 58, to col. 4, l. 8).
12. In addition, Kelm discloses:
Another preferred additional component of the solid dispersions
of the subject invention is a polyethylene glycol (PEG). . . .
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Preferred PEGs are those with nominal molecular weights in
excess of about 1500 daltons, preferably from about 2000 to
about 20,000 daltons, more preferably from about 3000 daltons
to about 8000 daltons. . . . PEGs are incorporated in the subject
solid dispersions at levels of from 0% to about 60%, preferably
from about 20% to about 40%.
(Id. at col. 4, ll. 19-31.)
13. Kelm also discloses that a preferred solid dispersion “consist[s]
essentially of . . . tebufelone, poloxamer, polysorbate and PEG” (id. at col. 4,
ll. 32-36).
14. Ghebre-Sellassie discloses the use of a solid pharmaceutical
dispersion to “increase the bioavailability of various water insoluble drugs
by increasing their dissolution rates which in turn produce[s] increases in
both the rates and extent of the drugs absorption” (Ghebre-Sellassie 5: 5-9).
15. In particular, Ghebre-Sellassie discloses that “[n]early any
water-insoluble drug may be formulated in the practice of [its] invention”
(id. at 5: 15-16).
16. Ghebre-Sellassie also discloses that “[s]uitable carrier polymers
that are useful in the formation of the solid drug dispersion include, but are
not limited to, polyvinylpyrrolidone (PVP), high molecular weight
polyethylene glycol (PEG), [such as PEG 6000,] . . . and mixtures thereof”
(id. at 6: 6-26).
17. In addition, Ghebre-Sellassie discloses that “the addition of a
plasticizer/solubilizer . . . results in a chemical environment that readily
lends itself to dispersion formation” and that “[s]uitable
plasticizers/solubilizers . . . include low molecular weight polyethylene
glycols such as PEG 200, PEG 300, PEG 400 and PEG 600” (id. at 7: 1-11).
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18. Ghebre-Sellassie also discloses including surfactants, such as
Tween 80, Tween 60, and Tween 20 (id. at 7: 22-26).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). In addition, “any
need or problem known in the field of endeavor at the time of invention and
addressed by the patent can provide a reason for combining the elements in
the manner claimed.” Id. at 420.
Obviousness analysis “need not seek out precise teachings directed to
the specific subject matter of the challenged claim.” Id. at 418. Instead, it
proper to “take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” Id. “A person of ordinary skill is
also a person of ordinary creativity, not an automaton.” Id. at 421.
Analysis
Kelm discloses a solid dispersion comprising: (a) from about 15% to
about 75% of a poorly water soluble active substance, specifically
tebufelone, and (b) from about 25% to about 65% of a poloxamer surfactant
having a melting point of about 40°C or greater (Findings of Facts (FF) 7 &
9). Kelm also discloses that the composition may include: (c) from 0% to
about 60%, preferably from about 20% to about 40%, polysorbates and
(d) from 0% to about 60%, preferably from about 20% to about 40%, PEG
(FF 11-13).
Rozsa discloses (3S,2'R)-3-{1-[2'-(ethoxycarbonyl)-4-phenylbutyl]-
cyclopentane-1-carbonylamino}-2,3,4,5-tetrahydro-2-oxo-1H-
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1-benzazepine-1-acetic acid and physiologically acceptable salts thereof “for
preparing pharmaceutical compositions for the treatment and/or prophylaxis
of gastrointestinal blood circulation disturbances” (FF 4 & 6). Rozsa also
discloses preparing these pharmaceutical compositions using customary
solid or liquid carrier substances and/or customary pharmaceutical auxiliary
substances, such as solubilizing agents (FF 5). We agree with the Examiner
that it would have been prima facie obvious to incorporate Rozsa’s salt into
Kelm’s carrier composition.
Appellant argues, however, that Rozsa “does not describe the calcium
salt recited in claim 1” (App. Br. 7). We are not persuaded. Instead, we
agree with the Examiner that “one of skill in the art would [have]
immediately envisioned the formation and use of all the known
physiological pharmaceutically acceptable salts including the calcium salt of
this compound” (Ans. 6) and therefore the calcium salt would have been
obvious.
Appellant also argues that “Rozsa does not mention problems with
low bioavailability of the compounds described therein” (App. Br. 7). In
addition, Appellant argues: “Nowhere in Kelm . . . is it suggested that this
specific formulation is also useful in the formulation of other active
substances. Further, it is well known in the art that a formulation which is
useful for one compound is often not useful for another compound.” (Id.)
We are not persuaded. We agree with Appellant that the Examiner
has not pointed to a teaching in Rozsa that explicitly recites that its
compounds are poorly water soluble. However, Rozsa does disclose
including solubilizing agents in the pharmaceutical composition (FF 5).
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Moreover, the evidence of record indicates that water solubility is one of the
properties of an active substance that is considered in determining
appropriate carriers for forming a pharmaceutical composition (FF 1 & 9).
Thus, even if it was not known in the art at the time of the present invention
that the claimed active substance is poorly water soluble, we conclude that it
would have been obvious to determine its water solubility in selecting
appropriate carriers. Given the fact that it is poorly water soluble (FF 2), we
agree with the Examiner that it would have been obvious to include it in the
carrier described in Kelm. Although a formulation that is useful for one
compound may not be useful for another compound, given the fact that
tebufelone and the claimed active substance are both poorly water soluble
(FF 2 & 9), we agree with the Examiner that there is a reasonable
expectation for success.3
In addition, Appellant argues that the “invention described in the
present application relates to a solid solution formulation in contrast to the
solid dispersion formulation of Kelm” (App. Br. 8). In particular, Appellant
argues: “A solution is a homogeneous mixture in which solute molecules
are individually solvated by solvent molecules. A dispersion, on the other
hand, is a non-homogeneous mixture such as an emulsion or suspension in
which minute particles of dispersed phase are suspended in a continuous
phase.” (Reply Br. 4.)

3 We note that this is further supported by Ghebre-Sellassie, which is
included in the second rejection and describes a solid dispersion containing
PEG and polysorbate to increase the bioavailability of nearly any water-
insoluble drug (FF 14-18).
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We are unpersuaded. Although we agree that there is a difference
between the terms “solution” and “dispersion,” we do not agree that
Appellant has adequately explained how the claimed “solid solution” differs
from the term “solid dispersion” as this term is defined Kelm (FF 8) other
than that the tebufelone has been replaced by the claimed active substance.
In this regard, we note that, like the solid dispersion of Kelm, the
Specification discloses preparing the “solid solution” by blending melted
components and cooling the resulting melt mixture so that it forms a solid
(FF 3). Thus, we agree with the Examiner that the evidence of record
supports the conclusion that Kelm as combined with Rozsa suggests the
claimed solid solution.
With regard to the rejection over Rozsa, Kelm, and Ghebre-Sellassie,
Appellant additionally argues that, “[a]lthough both PVP and PEG are
mentioned as possible carriers . . . , [Ghebre-Sellassie] does not state that the
two are analogous” (App. Br. 10). We note initially that this argument has
no relevance to claim 1, nor has Appellant clearly indicated that claim 10 is
being separately argued.
However, even with regard to claim 10, which recites that the polymer
is PVP or polyvinyl alcohol, we are not persuaded. Ghebre-Sellassie lists
both PVP and high molecular weight PEG, such as PEG 6000, as possible
carriers in a solid dispersion (FF 16). Ghebre-Sellassie also discloses that
suitable plasticizers/solubilizers include low molecular weight PEG, such as
PEG 200, 300, 400, and 600 (FF 17). However, the fact that Ghebre-
Sellassie teaches that low molecular weight PEG can be used for a different
purpose than PVP does not support Appellant’s position that it would not
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have been obvious to replace Kelm’s PEG, which has a molecular weight in
excess of about 1500, preferably from about 2000 to about 20,000 (FF 12),
with PVP, as described as an alternative to high molecular weight PEG in
Ghebre-Sellassie (FF 16).
Conclusion
The evidence supports the Examiner’s conclusion that it would have
been obvious to include a calcium salt of Rozsa’s compound in Kelm’s
carrier composition to form a solid solution. We therefore affirm the
obviousness rejections over Rozsa and Kelm, alone or in view of Ghebre-
Sellassie.
II
With regard to the rejections over Rozsa, Singh, and Lambert, alone
or in view of Pformulate, the Examiner relies on Rozsa as discussed above
(Ans. 10-11).
The Examiner relies on Singh for teaching “a formulation for
pharmaceutical water insoluble drug, cyclosporine with improved
bioavailability” (id. at 11). The Examiner finds that “Singh teaches a
capsule formulation that comprises the hydrophobic drug, a hydrophilic
solvent, and surfactant,” and that the “hydrophilic solvent exemplified is
propylene glycol and the surfactant is polyoxyethylene castor oil
(Cremophor ®)” (id.). The Examiner concludes that it would have been
obvious “to combine the two references since the compound is poorly
soluble in water (hydrophobic), and Singh utilizes a formulation that is
geared to hydrophobic/water insoluble drug, to be readily dispersed with
good bioavailability” (id. at 12).
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The Examiner relies on Lambert for teaching “a number of solvents
appropriate for compositions of poorly soluble drugs” including “DMSO,
propylene glycol, polyethylene glycol (PEG), N-methyl-2-pyrrolidone, and
polyvinylpyrrolidone[,] PVP or PEG [being] particularly preferred” (id.).
The Examiner concludes that it would have been obvious “to substitute
solvents . . . as suggested by Lambert, and produce the instant invention” (id.
at 13).
With regard to claim 2, the Examiner relies on Pformulate for
teaching “that disintegrants are excipients that are added to a tablet or
capsule to enhance the dissolution of products particularly when rapid
release (immediate release) of a drug is desired” (id. at 14).
Issue
Does the evidence support the Examiner’s conclusion that it would
have been obvious to modify Singh’s carrier composition to add Lambert’s
solvent to form a solid solution?
Findings of Fact
19. Singh discloses a “homogenous alcohol free, free flowing, clear
and transparent pharmaceutical composition containing Cyclosprin . . . in a
hydrophillic carrier medium comprising propylene glycol, a
transesterification product of a natural vegetable oil triglyceride and a
polyalkylene polyol[,] . . . polyethylene hydrogenated castor oils[,] . . . and
Glycerol Triacetate or Triacetin” (Singh, Abstract; see also col. 8, ll. 2-11).
20. In particular, Singh discloses that, unlike prior art compositions
(Examples 1-3), which are described as semi-solid masses that are “suitable
only for soft gelatin capsule formulation,” its invention (Examples 5-9)
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provides “a clear, homogenous solution which remains clear and stable at
temperatures between 15° to 45° C. without any jelly like flake formation”
and are therefore “suitable for formulating as a drink solution or soft gelatin
capsules” (id. at col. 10, l. 17, to col. 12, l. 65).
21. It is now undisputed that a “solid solution” is a solid (Ans. 19
(“A solid solution is a solution in solid form”) & Reply Br. 5).
Principles of Law
“A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553
(Fed. Cir. 1994). If a proposed modification would render the prior art being
modified “inoperable for its intended purpose,” then there is no suggestion
to make the proposed modification. In re Gordon, 733 F.2d 900, 902 (Fed.
Cir. 1984).
Analysis
Singh discloses a “free flowing” composition that is “suitable for
formulating as a drink solution or soft gelatin capsules” (FF 19-20).
Although the soft gelatin capsules may be solid, the evidence supports
Appellant’s position that the solution inside the capsule is a “free flowing”
liquid (id.).
Appellant argues:
Singh actually teaches away from the presently claimed
invention. In particular, the modifications to Singh necessary to
arrive at the presently claimed invention would yield a
formulation which would no longer be free flowing, clear and
transparent, as required of Singh. Thus, the modifications
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necessary to arrive at the presently claimed invention would
render the formulation unsuitable for the purpose intended by
Singh.
A person of skill in the art would not be motivated to modify
the teachings of a reference in a way that would render the prior
art unsatisfactory for its intended purpose. Because the
modifications to Singh are directly contrary to Singh’s goals of
providing a free flowing, clear and transparent solution, the
skilled artisan would not be inclined try the substitutions
proposed in the Office Action.
(App. Br. 11.) We agree.
We recognize that the Examiner likely maintained the rejections
relying on Singh based on Appellant’s previous argument that a solid
solution is a liquid (App. Br. 8). However, now that Appellant has clarified
the record “by acknowledging that a solid solution is a solid at ordinary
(room) temperatures” (Reply Br. 5), which is consistent with the
Specification, which teaches preparing the formulation by solidifying the
mixture at room temperature (FF 3), we agree with Appellant that the
rejections relying on Singh should be withdrawn.
Conclusion
The evidence does not support the Examiner’s conclusion that it
would have been obvious to modify Singh’s carrier composition to add
Lambert’s solvent to form a solid solution. We therefore reverse the
obviousness rejections over Rozsa, Singh, and Lambert, alone or in view of
Pformulate.
SUMMARY
We affirm the obviousness rejections of claims 1, 2, 4-10, 13, and 14
over Rozsa and Kelm, alone or in view of Ghebre-Sellassie. However, we
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reverse the obviousness rejections of claims 1, 2, 4-10, 13, and 14 over
Rozsa, Singh, and Lambert, alone or in view of Pformulate.
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. § 1.136(a).

AFFIRMED

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