Ex Parte Sheskey et al

Patent Trial and Appeal Board

Dec 19, 2012

10485655 (P.T.A.B. Dec. 19, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PAUL J. SHESKEY and COLIN M. KEARY
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Appeal 2011-008383
Application 10/485,655
Technology Center 1600
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Before DONALD E. ADAMS, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
granulation process and a pharmaceutical composition comprising a
granulated material produced from such process. The Patent Examiner
rejected the claims as obvious and on the ground of non-statutory
obviousness-type double patenting. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.

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STATEMENT OF THE CASE
Claims 25-36 are on appeal. Claim 25 is representative and reads as
follows:
25. A granulation process comprising:
contacting a mass of solid particles having an average particle size of
less than 1000 micrometers with a foam comprising a discontinuous gas
phase and a continuous fluid phase, whereby the foam lamellae break as they
pass through the mass of solid particles, to produce a granulated material.

The Examiner rejected the claims as follows:
• claims 25-31 and 34-35 under 35 U.S.C. § 103(a) as unpatentable
over Hardie-Muncy,1 Omura,2 and Bakal;3
• claims 32-33 under 35 U.S.C. § 103(a) as unpatentable over Hardie-
Muncy, Omura, Bakal, and Mayer;4
• claims 25, 27-31, and 34-36 under 35 U.S.C. § 103(a) as
unpatentable over Lopez5 and Alkire;6
• claims 32-33 under 35 U.S.C. § 103(a) as unpatentable over Lopez,
Alkire, and Mayer; and
• claims 25-36 on the ground of non-statutory obviousness-type
double patenting as unpatentable over claims 14-19 of Sheskey.7

1 US Patent No. 4,476,145 issued to Darlene A. Hardie-Muncy et al., Oct. 9,
1984.
2 US Patent No. 5,720,304 issued to Yoshiaki Omura, Feb. 24, 1998.
3 US Patent No. 4,572,836 issued to Abraham I. Bakal, Feb. 25, 1986.
4 US Patent No. 4,719,112 issued to Jean P. Mayer et al., Jan. 12, 1988.
5 US Patent No. 3,607,364 issued to Benito Lopez et al., Sep. 21, 1971.
6 US Patent No. 5,607,697 issued to Todd G. Alkire et al., Mar. 4, 1997.
7 Patent No. US 7,011,702 B2 issued to Paul J. Sheskey et al., Mar. 14,
2006.

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OBVIOUSNESS
I. The Rejections over Combinations including Hardie-Muncy
Claims 26-36 have not been argued separately and therefore stand or
fall with claim 25. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner’s position is Hardie-Muncy is a method for
agglomerating moisture sensitive material. (Ans. 3.) The Examiner found
that Hardie-Muncy disclosed a method consisting of dissolving or dispersing
a hydrophilic binding agent in water, generating a foam, and adding particles
and then mixing well. (Id. at 4.) The Examiner also found that Hardie-
Muncy disclosed that examples of binders included cellulosic materials such
as water soluble salts of carboxymethyl cellulose and ionic esters and ethers
of cellulose. (Id.) The Examiner further found that Hardie-Muncy taught
that mixing is complete when the foam has collapsed and formed a film
which lightly coats the added particles. (Id.)
Additionally, the Examiner found that Hardie-Muncy disclosed an
example in which (i) gelatin and water were mixed and whipped to form a
foam, (ii) a dehydrated vegetable mixture comprising onion, parsley, and
celery were then added to the foam and blended with a bench top churn, (iii)
large breadcrumbs were then added to the vegetable-foam mixture, (iv) and
the dried form agglomerate was then granulated. (Id.)
The Examiner also found that Hardie-Muncy did not disclose the
particle size of the dehydrated herbs used in its example. (Id.) However, the
Examiner found that Bakal, which is directed to a stabilized herb
composition, cured this deficiency. (Id.) The Examiner found that Bakal
taught that fresh herbs add much desired flavor to many foods and that the
size reduction of the herbs is essential to achieve proper flavor in the final
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product. (Id.) The Examiner also found that Bakal taught reducing the
herbs to less than 1300 microns and then further reducing the size using a
colloid mill or silent cutter to form particles averaging less than about 600
microns, and preferably from about 300 to about 200 microns so that they
can pass through a mesh screen. (Id. at 4-5.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to combine the
teachings of Hardie-Muncy and Bakal by using parsley, onion, and celery
particles of less than 600 microns. (Id. at 5.) The Examiner found that a
skilled artisan would have been motivated to use this particle size to enhance
the flavor of the resulting product because Bakal taught that size reduction is
essential to achieve proper flavor. (Id.) The Examiner also concluded that it
would have been obvious to combine the teachings of Hardie-Muncy and
Bakal and utilize cellulose material as the binder to form the foam. (Id.)
The Examiner found that an artisan would have been motivated to substitute
the exemplified gelatin in Hardie-Muncy with cellulosic material as it was
specifically disclosed as a binder material and a skilled artisan would have
good reason to pursue known options within the artisan’s technical grasp.
(Id.)
Appellants contend that Hardie-Muncy taught away from the claimed
invention’s particle size limitation by teaching that the largest sized particles
and/or least readily hydrated particles are contacted with a foam. (App. Br.
12)(Hardy-Muncy col. 2, ll. 52-53). Appellants assert that the material
produced from the foam coating may then be fractured, granulated or
otherwise divided into smaller pieces. (Id.) According to Appellants, the
claimed invention instead “us[es] agglomeration to make small particles
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larger, not to coat big particles that are [subsequently] ground into smaller
particles,” i.e., a granulated material. (Id.)
After considering the evidence and the arguments, we agree with
Appellants that Hardie-Muncy did not teach or suggest a process of
contacting a mass of solid particles with a foam to produce a granulated
material. Rather, the process disclosed by Hardie-Muncy required a further
processing step to produce a granulated material. Specifically, in Example
1, Hardie-Muncy taught that after contacting its particles with foam, the
foam agglomerated mixture was then spread upon a drying tray and dried;
the dried, foam-agglomerate was then granulated by pushing the
agglomerate through a separator and further sieved. (Hardie-Muncy col. 3,
ll. 25-64.)
Indeed, the Examiner found that in Hardie-Muncy’s process, foam
and particles are mixed well; the foam agglomerated mixture was then dried;
and the dried foam agglomerate was then granulated. (Ans. 4.) However,
according to the Examiner, “as long as the resulting product is granulated it
would read on the instantly claimed process.” (Id. at 19.) We disagree with
the Examiner as the claimed invention requires the contact between the solid
particles and the foam to produce a granulated material. (Claim 25.)
Accordingly, we reverse the obviousness rejections over combinations
including Hardie-Muncy.

II. The Rejections over Combinations including Lopez and Alkire
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Claims 26-36 have not been argued separately and therefore stand or
fall with claim 25. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner’s position is that Lopez taught a process for coating
pharmaceutical solid dosage forms, such as tablets granules, and pellets.
(Ans. 9.) The Examiner found that the process in Lopez comprised applying
a foamed coating medium to the solid dosage form surface and then
destroying the foam to evenly coat the solid form. (Id.) The Examiner also
found that Lopez taught that: foaming of the coating may be carried out by
any conventional means, including using a gaseous medium such as air; the
coating medium may be of such a form that the foamed coating medium is
not stable for any appreciable length of time; urging of the coating medium
against the solid form surface may be effected by tumbling the solid form
onto a tumbler surface such as provided by a conventional coating pan; the
high standard of coating achieved is attributed to the simultaneous spreading
and breaking down of the foamed coating medium as the solid form tumbles
on the tumbler surface; the coating medium may be of almost any type; and
the inventive process advantageously shortens dwelling and drying times.
(Id.)
The Examiner found that Lopez did not specifically exemplify a
granulated formulation, contacted the coating medium with solid forms by
tumbling, or a coating medium comprising a cellulose. (Id. at 10.)
Additionally, the Examiner found that Lopez did not specify the particle size
of the dosage forms. (Id.) However, the Examiner found that Alkire cured
these deficiencies. (Id.)
The Examiner found that Alkire taught taste masking microparticles
for use in solid oral dosage forms, comprising a coating material that retards
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the dissolution of the pharmaceutical ingredient in the mouth along with the
objectionable taste of the pharmaceutical ingredient. (Id.) The Examiner
also found that Alkire taught that the amount of active agent used can vary
from a few milligrams to 2500 mg or more; the protective coating material
includes polymers such as cellulose and cellulose derivatives, and gelatin;
the coating will generally be used in at least about 5 percent based on the
weight of the resulting microparticles, and may be used greater than 100
percent of the weight of the core; particles should be no longer than 1000
microns; microparticles are discreet particles and can be granular material.
(Id. at 10-11.) Additionally, the Examiner found that Alkire disclosed in
Example 2 coating solutions consisting of polyvinylpyrrolidone,
ethylcellulose, and monoglycerides which were dissolved in a mixture of
alcohol and acetone, which correlates to 90% liquid diluent and 5.5% of
ethyl cellulose. (Id. at 11.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have combined
the teachings of Lopez and Alkire and used microparticles as the solid
dosage form. (Id.) The Examiner reasoned that the combination involved
using known dosage forms such as microparticles when forming coated solid
dosage forms. (Id.) The Examiner also concluded that it would have been
obvious to use a tumbler to urge the coating medium against the solid form
as Lopez specifically disclosed this method and further taught that is
provides a high standard of coating. (Id. at 12.) The Examiner further
concluded that it would have been obvious to use the taste masking coating
of Alkire as the coating solution in Lopez, motivated by Lopez’ teaching that
almost any coating solution could be used and Alkire’s teachings that its
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coating advantageously retards the dissolution of the pharmaceutical
ingredient in the mouth and the objectionable taste of the pharmaceutical
ingredient. (Id.) Additionally, the Examiner found it would have been
obvious to use a drug as the solid particles, motivated by Lopez’ teaching
that its process is used for coating pharmaceutical solid forms. (Id.)
Appellants contend that Lopez “teaches coating tablets, there is no
teaching of granulation in Lopez.” (App. Br. 15.) Appellants assert that
Alkire “is also a coating reference.” (Id.) According to Appellants, their
Specification teaches the difference between coating and granulation by
stating:
If the fluid composition does not comprise a binder for the solid
particles, the particles are at least partially coated with the
foam but usually no agglomeration takes place. This method is
particularly useful for coating powders, such as pharma-
ceutical excipients, with drugs, colorants or other materials in
case no agglomeration of the solid particles is desired.

(Id.)(quoting, with emphasis, Spec. 9, ll. 24-29). Further, Appellants submit
the declaration of Dr. Arthur H. Kibbe as evidence regarding “how those
skilled in the art define granulation and coating.” (App. Br. 15.) According
to Dr. Kibbe,
In layman’s terms granulation, or agglomeration, refers to
adhering numbers of particles together to make a granulate,
usually to reduce dust, increase particle size uniformity,
improve powder flow or reduce segregation (for example, to
ensure uniform drug dosage and improve tablet quality).
Coating on the other hand, refers to applying a layer of material
to a substrate to isolate the substrate from an environment. In
the art, great pains are taken to prevent coated particles from
sticking together, i.e., much work in coating is precisely to
avoid granulation.

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(Dec. Dr. Arthur H. Kibbe,8 ¶ 3.)
After considering the evidence and arguments, we conclude that the
record supports a conclusion of obviousness. In particular, we note that,
along with the portion quoted by Appellants, the Specification expressly
states, “[d]epending on the type of polymer and optional other components
in the foam, the components of the foam coat solid particles with or without
agglomeration of the solid particles.” (Spec. 9, ll. 22-24.) In other words,
the foam can coat solid particles and also produce an agglomeration. As
the portion quoted by Appellants explains, no agglomeration takes place if
the fluid composition does not comprise a binder for solid particles. (Id. at
ll. 24-25.) However, “[i]f the fluid composition comprises a binder for the
solid particles, the particles agglomerate upon contacting the foam with the
solid particles.” (Id. at ll. 30-32.) The Specification also lists polymers that
can usually act as a polymeric binder. (Id. at ll. 32.) As the Examiner
correctly explained, the polymers listed in the Specification and recited by
the claimed invention include gum arabic which is also a polymer used in an
exemplary coating formulation of Lopez, referred to as acacia gum. (Ans.
20.) Also, as the Examiner concluded, and Appellants have not disputed,
using cellulose, another polymer listed in the Specification and instant
claims, would have been obvious. Therefore, we find that the Examiner
provided sound reasoning, supported by the evidence, that the prior art foam
medium would possess a binder which would inherently produce
agglomeration upon contact with the particles in the process of the combined
prior art.

8 Declaration of Dr. Arthur H. Kibbe, submitted Nov. 16, 2009.
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While we recognize Dr. Kibbe’s apparent expertise in the field of
pharmaceutical excipients, we do not find that his statements and
conclusions carry persuasive weight. In particular, we do not find that Dr.
Kibbe’s statements establish that a coated material may not also be a
granulated material. Rather, Dr. Kibbe states that “granulation, or
agglomeration, refers to adhering numbers of particles together to make a
granulate” and then states that “great pains are taken to prevent coated
particles from sticking together, i.e., much work in coating is precisely to
avoid granulation.” (Dec. ¶ 3.). In other words, coated particles can adhere
to make a granulate, which satisfies Dr. Kibbe’s definition of granulation.
Indeed, according to Dr. Kibbe, “great pains” are required to avoid coated
particles from becoming a granulated material (id.) that is, of course, “in
case no agglomeration of the solid particles is desired,” as acknowledged in
the Specification (Spec. 9, ll. 27-28).
Accordingly, we affirm the obviousness rejections over combinations
including Lopez and Alkire.

OBVIOUSNESS-TYPE DOUBLE PATENTING
Claims 26-36 have not been argued separately and therefore stand or
fall with claim 25. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner’s position is that “[a]lthough the conflicting claims are
not identical, they are not patentably distinct from each other because both
sets of claims overlap in scope.” (Ans. 16 (emphasis removed).) According
to the Examiner, Sheskey “claims a process for coating solid particles
wherein an aqueous air foam is contacted with the solid particles to be
coated, the aqueous air foam comprising a non-crosslinked cellulose ether,
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the foam having a foam quality of from 60 to 97%.” (Id.) The Examiner
found that Sheskey’s claims recite particles including “granules, tablets,
pellets, caplets, etc.” (Id.) Therefore, according to the Examiner, Sheskey’s
claims and the rejected claims are both “directed to a similar process of
coating particles.” (Id.) Additionally, the Examiner found that Sheskey’s
claims and the rejected claims are also both directed to similar subject
matter, i.e., granules. (Id.)
Appellants contend that unlike the Sheskey claims, the rejected claims
are directed toward “granulation, not coating, and they are believed to be
mutually exclusive.” (App. Br. 16.)(citing Spec. 9, ll. 22-29.)
The issue is whether the rejected claims are patentably distinct from
the claims of Sheskey wherein the method steps of the disputed claims are
the analogous, but wherein the prior art claims are directed to a coating.
Findings of Fact
1. Sheskey’s claim 14 recites, in part, “[a] process for coating solid
particles wherein an aqueous air foam is contacted with the solid particles to
be coated….” (Sheskey Claim 14.)
2. Sheskey’s Specification states “that foams can be produced which are
useful in various applications, such as granulating solid particles like
powders or coating solid particles like tablets….” (Col. 4, ll. 16-19.)
3. Sheskey’s Specification states that “the contact of the foam with the
powder is conducted in a mixing device, such as a high shear mixing device,
a low shear mixing device, a fluidized bed granulator, a roller compactor or
a spray dryer.” (Id. at col. 5, ll. 30-33.)
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4. Sheskey’s Specification states that “the foam lamellae generally break
and reform as they pass through the powder during granulation.” (Id. at col.
5, ll. 28-29.)
Principle of Law
An obviousness-type double patenting analysis entails two steps:
(1) construction of the claims of the patent and the claims in the application
to identify any differences, and (2) determination of whether the differences
in subject matter between the claims render the claims patentably distinct.
See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001).
Analysis
Sheskey’s claim 14 recites, in part, “[a] process for coating solid
particles wherein an aqueous air foam is contacted with the solid particles to
be coated….” (FF-1)(emphasis added). We look to Sheskey’s Specification
to learn the meaning of the claim term “contacted,” as well as to interpret the
coverage of the claim. See Geneva Pharm., Inc. v. GlaxoSmithKline PLC,
349 F.3d 1373 (Fed. Cir. 2003)(describing “certain instances” where the
Specification of an earlier patent may be used in an obviousness-type double
patenting analysis). Sheskey’s Specification states that “the contact of the
foam with the powder is conducted in a mixing device, such as a high shear
mixing device, a low shear mixing device, a fluidized bed granulator, a roller
compactor or a spray dryer.” (FF-3.) The Specification also states that “the
foam lamellae generally break and reform as they pass through the powder
during granulation.” (FF-4.) In view of these disclosures, we interpret the
claim term “contacted” to mean mixing or combining in a mixing device,
such as a high shear mixing device, a low shear mixing device, a fluidized
bed granulator, a roller compactor or a spray dryer. Thus, we conclude that
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the process of the rejected claims comprising contacting a mass of solid
particles with a foam, whereby the foam lamellae break as they pass through
the mass of solid particles, to produce a granulated material is not patentably
distinct from Sheskey’s process, wherein a foam is “contacted” with solid
particles, wherein such contact includes mixing or combining in a mixing
device such as a fluidized bed granulator. The fact that the rejected claims
are “limited to granulation” (App. Br. 16) does not render them patentably
distinct from Sheskey’s claims which encompass the recited steps for
producing a granulated material. (See Ans. 20-21.)

SUMMARY
We reverse the rejection of claims 25-31 and 34-35 under 35 U.S.C. §
103(a) as unpatentable over Hardie-Muncy, Omura, and Bakal;
we reverse the rejection of claims 23-33 under 35 U.S.C. § 103(a) as
unpatentable over Hardie-Muncy, Omura, Bakal, and Mayer;
we affirm the rejection of claims 25, 27-31, and 34-36 under 35
U.S.C. § 103(a) as unpatentable over Lopez and Alkire;
we affirm the rejection of claims 32-33 under 35 U.S.C. § 103(a) as
unpatentable over Lopez, Alkire, and Mayer; and
we affirm the rejection of claims 25-36 on the ground of non-statutory
obviousness-type double patenting as unpatentable over claims 14-19 of
Sheskey.

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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).

AFFIRMED

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