Ex Parte Kolter et al

Patent Trial and Appeal Board

May 26, 2016

11631368 (P.T.A.B. May. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/631,368 12/29/2006
123223 7590 05/31/2016
Drinker Biddle & Reath LLP (WM)
222 Delaware A venue, Ste. 1410
Wilmington, DE 19801-1621
FIRST NAMED INVENTOR
Karl Kolter
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.
074008-0394-01-286077 4187
EXAMINER
CRAIGO, WILLIAM A
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
05/31/2016 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):
IPDocketWM@dbr.com
penelope.mongelluzzo@dbr.com
DBRIPDocket@dbr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KARL KOLTER, MAXIMILIAN ANGEL, and
ANDREAS HABICH1
Appeal2013-003091
Application 11/631,368
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
fine-particle film coating. The Examiner rejects the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is BASF SE*. (App.
Br. 2.)
Appeal2013-003091
Application 11/631,368
STATEMENT OF THE CASE
Claims 1-27 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief. 2 Claim 1 is representative of the claims on appeal, and
reads as follows:
1. A rapidly dispersible, fine-particle film-coating composition
which is in powder form and is not prone to segregation for
coating pharmaceutical dosage forms, comprising:
a) 40-90% by weight of a polyvinyl alcohol-polyether graft
copolymer (component A),
b) 1-20% by weight of a polyvinylpyrrolidone or of a
vinylpyrrolidone-vinyl acetate-copolymer with a K value of
from 10 to 100 (component B)
c) 10-60% by weight of organic or inorganic pigment particles
having an average pigment particle size of less than 8 µm
(component C)
d) 0.5-15% by weight of a surfactant having an HLB of greater
than 10 (component D) and
e) 0-30% by weight of additional coating ingredients
(components E),
in which the pigment particles of component C are completely
surrounded by polymer,
where the total amount of components A to E is 100% by
weight.
2 Claims 28--41 are withdrawn from consideration. (Appeal Br. 2.)
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Application 11/631,368
Appellants request review of the following rejections:
I. Claims 1-24 under 35 U.S.C. § 103(a) over Kolter, 3 Porter,4 and
Smith; 5 and
II. Claims 25-27 under 35 U.S.C. § 103(a) over Kolter, Porter, Smith,
and further in view ofWheatley. 6
I. Obviousness over Kolter, Porter, and Smith
The Examiner finds that Kolter discloses a composition containing
elements A-E as recited in claim 1. (Final Act. 6-7.) The Examiner
acknowledges that "Kolter does not expressly teach the pigment particles are
completely surrounded by polymer" and that "the organic or inorganic
pigments have an average particle size of less than 8, 6, or 4 micrometers."
(Id. at 8.) The Examiner looks to the teachings of Porter and Smith to make
up for these deficiencies (see Id. at 8-9).
Appellants contend that the "additional publications [of Porter and
Smith] state that pigments consist of primary particles, which - due to
electrostatic forces (i.e. by an action defined by physical laws) - form
aggregates and agglomerates, which adhere very strongly. Thus, pigments
never exist as separated primary particles when dry or even when
suspended." (Appeal. Br. 8.) Appellants contend that the combination of
references "still does not present any hints for completely embedding
3 Kolter et al., W0/070224 Al, published Aug. 28, 2003 in German;
hereinafter "Kolter". All references in the present document are made to the
English language equivalent identified by the Examiner as US
2005/0107498 Al, published May 19, 2005 (see Final Act 6).
4 Porter et al., US 4,683,256, published July 28, 1987; hereinafter "Porter".
5 Smith et al., US 4,981,882, published Jan. 1, 1991; hereinafter "Smith".
6 Wheatley et al., US 5,258,436, published Nov. 2, 1993; hereinafter
"Wheatley".
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Appeal2013-003091
Application 11/631,368
pigments." (Id. at 9.) Appellants contend that "Smith suggests an
encapsulation of coating particles by a chemical reaction, i.e. a radical
polymerization of vinyl monomers with radical initiators in the presence of
coating particles .... [However,] such a method is unsuitable for
pharmaceutical" purposes. (Id.) "Rather than being physically embedded in
a coherent polymer matrix as described in the present application, the
pigments of Smith are chemically encapsulated." (Id.)
The issues are: (1) does the preponderance of evidence of record
support the Examiner's conclusion that the combination of references
discloses pigment particles within the claimed size range, and (2) does the
evidence support the encapsulation of these pigment particles?
Findings of Fact
FF 1. The Specification provides:
The film-coating compositions of the invention are
distinguished by the particles of component C being embedded
in a coherent polymer matrix. Coherent means that the matrix
forms a continuous phase. The individual pigment particles are
completely surrounded by polymer or embedded in the polymer
matrix. The polymer matrix is formed by polymeric
components A and B. The other components D and E are
homogeneously dispersed in this matrix. This corresponds to a
so-called "solid dispersion", in which the polymer matrix forms
the external phase, and the pigment particles form the internal
phase. The powder particles thus consist of a polymer matrix in
which the pigment particles are dispersed.
(Spec. 7, 11. 25-33 (emphasis added).)
FF2. The Specification provides that surfactants with an HLB (hydrophilic
lipophilic balance) of greater that 10 include:
Those particularly suitable are alkali metal salts of C8-C30 fatty
acids, C8-C30 alkylsulfonates, C8-C30-alkyl sulfates, C8-C30-
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Appeal2013-003091
Application 11/631,368
alkylarylsulfonates or dioctyl sulfosuccinate, ethoxylates of C8-
C30-fatty acids, C8-C30-fatty alcohols, fatty acid glycerides,
sorbitan fatty acid esters, sorbitan fatty alcohol ethers or
phenols, and polyoxypropylene-polyoxyethylene block
copolymers. Examples from the classes of substances
mentioned are sodium stearate, sodium oleate, sodium
laurylsulfonate, sodium laurylsulfate, polyoxyethylene (9)
monostearate, polyoxyethylene (10) stearyl/cetyl ether,
polysorbate 80, polysorbate 20, ethoxylated castor oil (35 EO),
ethoxylated hydrogenated castor oil (40 EO), ethoxylated 12-
hydroxystearic acid (15 EO), poloxamer 188, poloxamer 408.
(Spec. 6, 11. 1-10.)
FF3. Example 17 of Kolter teaches a coating composition comprising:
75:25 no1vvfovl ~li:>.Jhol-nolvc!hvknc i:dvcd 6000 51"'\.~
~· .:. .-· :i;. .-.' .... '!-..·' ...
. ,.., :nf'" ..... ..,, ... "'-1~"-i~er c:)i .. , ...... ~; ,.,,, ,n ' ·.
(.-{,.,() j'<';.:, qt'' l":cl~ f(){\~">1~' 94 ·)P<'i·i C:/;) .. }
\\,.::.~~ ·""'""' '· . ~) . ~. ~· :-; ··'~' .... . •. t,,, .. ··
6:4 vinylpynnlidoiw~v!ny! acdl~te copolymer J.5Ct,
(copolyvidonc)
1'>-·J·.;:,..,,,f'«''!~·'""'i:-, 1 li1'h" ;"•"ll.,1.!t):Y'· :'>\'t.'·"" >-~». ·_wq .. _·, J..Y .~ ....... t ,,,;'),,; J :V~"I:..);: ·"' .. -..... -..... ...... , ';.. -.~...._, .... ~ '$ ... ~ ,..! Ae-v . ,..
01~,-,1·t1."'.I•" :S-1· . .,,,'. ·'f'p t.11":~ ~· ,..\., •. \.,; .......... • (.-.I).. ....... ·' {·····$
Polycthyknc oxfdcypolypropy1.<:nc oxide b[Q;;.>k Yh
cupniyrner
Poloxamer 407
'l:·li ,.~·hi"-' .-Ji~n"'.fSf~ r;:i lf;"'.'~ 1'flt>:r·ifi;-. s•i.~·f\v"'.,<: :·"'"'.!'l. . ··c.-:··'··} ),,., .. ~.~.')o..~~-"' ''··· ........ <.~·:~ '·~: ............... ~ ....... :-. "'".~. '~"""'·'"' ,.,.,~ ........ ,..,
:'Ji')(} r:/io _,,.,_ ... ~e
"ndc
11tanium di<.l-Xidt:.
:Red iro11 oxide
(Kolter i-f 199; see Final Act. 6-7.)
FF4. Kolter teaches that preferred polymers include "water soluble polymers
such as polyvinyl alcohols having a degree of hydrolysis of 80-99%,
6:4 vinylpyrrolidone-vinyl acetate copolymer ( copolyvidone ),
polyvinylpyrrolidones having a K value of 12-90." (Kolter, i-f 63; Final
Act. 7 and 10.)
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Application 11/631,368
FF5. Porter teaches:
As to particle size, the pigment particle size range may be
between about 0.1 to 40 microns. The optimum mean particle
size range for iron oxides is about 0.5 to I micron, for lakes and
insoluble dyes is from about 1 to 5 microns, for titanium
dioxide is about 0.5 to 2 microns, and for channel black is about
0.2 to 1 micron.
(Porter col., 7, 11. 18-23; Final Act. 9.)
FF6. Smith teaches encapsulating solids. "[C]oating or encapsulation
processes are provided that enable aqueous dispersions of particles
which dispersions have been stabilized with basic dispersant." (Smith
col., 6, 11. 13-16; Ans. 10.) "Exemplary solids are water insoluble
solids such as inorganic solids including inorganic pigments such as
titanium dioxide." (Smith col. 6, 11. 13-16; Ans. 9.) Smith teaches that
the size of titanium dioxide pigment particles are 0.1-0.7 microns
(Smith col. 7, 11. 5---6; Ans. 9.)
FF7. Smith teaches that "the coated particles can find application in
electronic, medical and other applications." (Smith col., 6, 1. 66; Ans. 9
and 10.)
Principle of Law
"[M]otivation to combine is ... inextricably linked to the level of
ordinary skill .... If the level of skill is low, ... then it may be rational to
assume that such an artisan would not think to combine references absent
explicit direction in a prior art reference. If, however, ... the level of skill is
[high] ... , then one can assume comfortably that such an artisan will draw
ideas from chemistry and system engineering-without being told to do so."
Dystar Textilfarben Gmbh & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1370 (Fed. Cir. 2006).
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Application 11/631,368
Analysis
Claim 1
Appellants take issue with the Examiner's interpretation of the claim
language "completely surrounded by polymer." Specifically, Appellants
contend that this claim language excludes "encapsulation of coating particles
by a chemical reaction ... [because] such a method is unsuitable for
'pharmaceutical' purposes." (Appeal. Br. 9.)
The Examiner's position is that "the presently claimed coating
composition does not recite any limitations which would distinguish
pigment particles completely surrounded by polymer using physical means
from pigment particles completely surrounded by polymer using chemical
means because both means result in a pigment particle completely
surrounded by polymer as presently claimed." (Ans. 9.)
We look to the Specification to determine the meaning of the phrase
"completely surrounded by polymer," giving the claims their broadest
reasonable interpretation consistent with the Specification. In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). The Specification in reference to a
coherent polymer matrix describes that "[t]he individual pigment particles
are [either] completely surrounded by polymer or embedded in the polymer
matrix .... [Forming] a so-called 'solid dispersion', in which the polymer
matrix forms the external phase, and the pigment particles form the internal
phase. The powder particles thus consist of a polymer matrix in which the
pigment particles are dispersed." (FF 1.) In light of this description in the
Specification we interpret that either completely surrounding a pigment
particle with a polymer or embedding a pigment particle within a polymer
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Application 11/631,368
matrix both achieve the same thing in having the polymer form the external
phase while the pigment is located on the inside.
We agree with the Examiner that the Specification provides no
additional insight that would indicate that the claims somehow exclude the
use of a chemical means to surround or encapsulate the pigment particles.
Accordingly, we are not persuaded by Appellants' contention that the claim
language excludes encapsulation of pigment particles by a chemical means.
Appellants contend that "Smith does not employ ingredients all of
which are approved for pharmaceutical use by the FDA" (App. Br. 9).
We are not persuaded. We agree with the Examiner that "[ t ]he
subject matter of the present claims is directed to a product and not a method
of use. . . . [Furthermore,] a recitation of the intended use of the claimed
invention must result in a structural difference between the claimed
invention and the prior art." (Ans. 8.) "An intended use or purpose usually
will not limit the scope of the claim because such statements usually do no
more than define a context in which the invention operates." Boehringer
Ingelheim Vetmedica v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed.
Cir. 2003) (citing Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)).
Even if we were to ascribe some special meaning to the term
"pharmaceutical," which we do not, we find that the Examiner has
sufficiently established that the products used in Smith's process are
generally considered suitable for pharmaceutical purposes. The Examiner
finds, and Appellants do not rebut, that
[t]he polymers suggested by Smith for completely surrounding
the pigment particles are similar in composition and
polymerized using radical polymerization in the same way as
the preferred polymers used in Kolter for coating
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Application 11/631,368
pharmaceutical dosage forms; for example, polyvinyl alcohol,
polyvinylpyrrolidone, methacrylic acid, and polyvinyl acetate
taught by Kolter are all made by radical polymerization of
ethylenically unsaturated monomers.
(Ans. 9.) We are equally unpersuaded by Appellants' contention that "[t]he
FDA also requires far more stringent testing for any known compounds that
were 'chemically altered"' (App. Br. 11 ); merely requiring additional testing
does not provide evidence that such chemically altered compositions are not
suitable for pharmaceutical purposes.
Appellants contend that "pigment particles are known to be difficult to
keep isolated and tend to form agglomerates" citing several references 7 in
support. (App. Br. 6-7.) "[A]ll of the enclosed additional publications
[cited by Appellant] state that pigments consist of primary particles, which -
due to electrostatic forces (i.e. by an action defined by physical laws) - form
aggregates and agglomerates, which adhere very strongly. Thus, pigments
never exist as separated primary particles when dry or even when
suspended." (Id. at 8.)
We recognize but are not persuaded by Appellants' contention. Here,
Porter in the background section explains that "when this fine polymer-
pigment mixture is stirred into water and dispersed, the polymer makes
lumps and fish eyes because it agglomerates, and the result is not really a
uniform dispersion." (Porter col. 1, 1. 43--47.) Thus, the prior art recognizes
7 The "Pigment Handbook", Volume III, edited by Temple C. Patton, Wiley-
Interscience, 1973; The "Color Handbook", chapter "Pigment
Characteristics", as published by www.specialchem4coatings.com.; The
"Handbook of pharmaceutical excipients", 5th Edition, 2006; The brochure
"Concrete Coloring with Iron Oxide Pigment" by the Hamburger Color
Company, October 1997, by Jack Dunnous. (See App. Br. 6-7 & 19.)
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Application 11/631,368
that there is a problem in dissolving pigments in water in order to create
dispersions that can ultimately be used for coatings. (See Porter, Title &
Abstract.) Recognizing that agglomeration is an issue Porter includes
plasticizer with the polymer-pigment mixture in order to overcome this
agglomeration problem. Accordingly, Appellants' arguments with respect to
the pigment particles is not persuasive because Porter does not disclose the
use of pigment particles alone, instead Porter teaches the addition of
plasticizer with the pigment particle. Porter teaches the use of pigment
particles in the claimed size range for use in the composition. Even if
pigment particles need to be processed to achieve the size range disclosed in
Porter, the reference still teaches the use of pigments in that size range in
their polymer mix. (FF5.)
Appellants also contend that Dr. Kolter's Declaration8 established
"that pigment particles for pharmaceutical use provided in dry form
necessarily form agglomerates and behave as larger single particles." (App.
Br. 6.) Although we recognize that the Kolter Dec. establishes that
comparative examples 17 and 18 disclosed in Kolter do not produce particles
within the size range claimed (see Kolter Dec. 8), the current rejection is on
the ground of obviousness and the Examiner relies on the teachings of Porter
and Smith to arrive at the claimed composition. We agree with the
Examiner's position that the Kolter Dec. is not sufficiently persuasive
because
the need to grind purchased pigment particles to a particular
size was known and practiced to provide water dispersible
polymeric coating compositions for pharmaceuticals .... Porter
8 Declaration under 37 C.F.R. § 1.132 by Dr. Karl Kolter, signed May 25,
2010 ("Kolter Dec.").
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Application 11/631,368
expressly teaches it was known that water dispersible polymer
pigment coating mixtures suffered the drawback of forming
agglomerates in water .... [Indeed] Porter's solution to this
problem is to mix a surface active agent with the polymer and
pigment particles prior to grinding [] the particles to the same
size as claimed.
(Final Act. 3.)
Appellants contend that there is "[n]o objective reason to combine the
methods." (App. Br. 10-11.)
We are not persuaded by Appellants' contentions. Here, all references
relied on by the Examiner are directed to coating materials using pigment
particles. While Kolter and Porter may have emphasized the use of their
coating products for edible pharmaceutical compositions, this does not
diminish the teaching in Smith that their disclosed coating material can also
find use in medical applications (FF7). Thus, the problem considered by all
three references is the ability to evenly distribute pigment particles within a
coating. Jn re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011) (a reference is
reasonably pertinent and thus analogous if it "would have commended itself
to an inventor's attention in considering his problem.")
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient rebuttal evidence or evidence of secondary
considerations that outweighs the evidence supporting the prima facie case.
As Appellants do not argue the claims separately, claims 2-12, 14--18 and
20-24 fall with claim 1. 37 C.F.R. § 41.37 (c)(l).
Claim 13
With respect to claim 13 Appellants contend that "the Examiner has
not set forth any objective reason for one of ordinary skill in the art to find
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Application 11/631,368
the composition claimed" obvious, specifically showing that "component C
(pigment particles), is present in a concentration of 5-10% by weight."
(App. Br. 11.)
We are not persuaded by Appellants' contentions for the same reason
set forth by the Examiner in the Answer. Specifically, we agree with the
Examiner that claim 13 is directed to the concentration of component B and
not component C as argued by Appellants. (Ans. 11; see Final Act. 11-12;
see also Kolter ("5-80% by weight of at least one further component
containing at least one functional group selected from the group consisting
of hydroxyl, amide and ester functions (component B)" (Kolter 12: claim 1)
that include components such as "polyvinylpyrrolidones, vinylpyrrolidone-
vinyl acetate copolymers" (Kolter i-f 58)).)
Claim 19
With respect to claim 19 Appellants contend that "the Examiner has
not set forth adequate objective reason for one of ordinary skill in the art to
combine the concentration of components." (App. Br. 12.)
We are not persuaded by Appellants' contentions for the reason set
forth by the Examiner in the Answer. (Ans. 11-15.) The Examiner notes
that "the teachings of Kolter are not limited to the teachings of Example 17."
(Ans. 13.) "[W]here the general conditions of a claim are disclosed in the
prior art, it is not inventive to discover the optimum or workable ranges by
routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955).
II. Issue: Obviousness over Kolter, Porter, Smith, and Wheatley
The Examiner has rejected claims 25-27 as obvious based Kolter,
Porter, Smith, and Wheatley (Final Act. 12-13). Appellants' only argument
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with respect to this rejection is that "Wheatley is not applied in a manner to
cure the deficiencies" of Kolter, Porter, and Smith (Appeal Br. 13). This
argument is not persuasive because, as discussed above, we conclude that
Kolter, Porter, and Smith would have made obvious the dispersible fine-
particle film coating composition. Accordingly, we affirm the rejection of
claim 25-27 for the reasons given by the Examiner (Final Act. 12-13).
SUMMARY
We affirm the rejection of claims 1-24 under 35 U.S.C. § 103(a) over
Kolter, Porter, and Smith.
We affirm the rejection of claims 25-27 under 35 U.S.C. § 103(a)
over Kolter, Porter, Smith, and further in view of Wheatley.
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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