Ex Parte Zeigerson

Patent Trial and Appeal Board

Dec 6, 2018

14541328 (P.T.A.B. Dec. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/541,328 11/14/2014
109357 7590 12/10/2018
Evonik Corporation
Intellectual Property Management
299 Jefferson Road
Parsippany, NJ 07054-0677
FIRST NAMED INVENTOR
Ehud Zeigerson
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.
2003Pl2001 WOUS02 8925
EXAMINER
GREENE, NAN A
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
12/10/2018 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):
ipm-na@evonik.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EHUD ZEIGERSON
(APPLICANT: EVONIK CORPORATION)
Appeal2017-008749
Application 14/541,328 1
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 3, 5-16, 19-
31, 42, and 43 (Non-Final Act. 2 2). Examiner entered rejections under the
judicially-created doctrine of improper Markush grouping and 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellant identifies "Evonik Corporation" as the real party in interest (Br.
1 ).
2 Examiner's March 3, 2016 Non-Final Office Action.
Appeal2017-008749
Application 14/541,328
STATEMENT OF THE CASE
Appellant's disclosure relates to "the production of emulsion-based
microparticles and a method for producing emulsion-based microparticles
containing biological or chemical agents" (Spec. 1: 10-11 ). Claims 1, 14,
and 43 are representative and reproduced below:
1. A method of preparing microparticles, comprising: (a)
preparing a first phase, said first phase comprising a solvent,
active agent and a polymer; (b) preparing a second phase
comprising a solvent; ( c) passing said first phase and said
second phase through a packed bed apparatus under laminar
flow conditions, wherein the packed bed apparatus contains a
packing material selected from the group consisting of metal,
ceramic, plastic and glass, and wherein the packing material is
spherical beads ranging in size from 20 to 1000 µm, and
wherein said method results in the formation of microparticles;
and ( d) collecting said microparticles containing said active
agent.
(Br. 13 (emphasis added).)
14. The method of claim 1, wherein said active agent is
selected from the group consisting of antioxidants, porosity
enhancers, solvents, salts, cosmetics, food additives, textile-
chemicals, agro-chemicals, plasticizers, stabilizers, pigments,
opacifiers, adhesives, pesticides, fragrances, antifoulants, dyes,
salts, oils, inks, cosmetics, catalysts, detergents, curing agents,
flavors, foods, fuels, herbicides, metals, paints, photographic
agents, biocides, pigments, plasticizers, propellants, solvents,
stabilizers, polymer additives,[]an organic molecule, an
inorganic molecule, antiinfectives, cytotoxics,
antihypertensives, antifungal agents, antipsychotics, antibodies,
proteins, peptides, antidiabetic agents, immune stimulants,
immune suppressants, antibiotics, antivirals, anticonvulsants,
antihistamines, cardiovascular agents, anticoagulants,
hormones, antimalarials, analgesics, anesthetics, nucleic acids,
steroids, aptamers, hormones, steroids, blood clotting factors,
hemopoietic factors, cytokines, interleukins, colony stimulating
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Application 14/541,328
factors, growth factors, growth factor analogs and fragments
thereof.
(Id. at 14)
43. A method of preparing microparticles, comprising: (a)
preparing a first phase, said first phase comprising a solvent,
active agent and a polymer; (b) preparing a second phase
comprising a solvent; ( c) passing said first phase and said
second phase through a packed bed apparatus under laminar
flow conditions, wherein the packed bed apparatus contains a
packing material selected from the group consisting of metal,
ceramic, plastic and glass, and wherein the packing material is
spherical beads ranging in size from 20 to 1000 µm, and
wherein said method results in the formation of microparticles;
and ( d) collecting said microparticles containing said active
agent, wherein said microparticles are from about 1 µm to about
200 µmin diameter.
(Id. at 17.)
Grounds of rejection before this Panel for review: 3
Claims 14 and 29 stand rejected under the judicially created doctrine
of improper Markush grouping.
Claims 1, 3, 5-10, 12-16, 19-25, 27-31, 42, and 43 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over the combination ofLi, 4
Wright, 5 Hovenkamp, 6 Huber, 7 and Edwards. 8
3 Examiner withdrew the nonstatutory double patenting rejection on this
record (see Ans. 11 ).
4 Li et al., US 4,183,681, issued Jan. 15, 1980.
5 Wright et al., US 6,379,704 B2, issued Apr. 30, 2002.
6 Tobias Benedikt Hovekamp Experimental and Numerical Investigation of
Porous Media Flow with regard to the Emulsion Process, Laboratory of
Food Process Engineering (ETH Zurich) (2002).
7 Huber, US 4,165,219, issued Aug. 21, 1979.
8 Edwards, US 4,501,501, issued Feb. 26, 1985.
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Application 14/541,328
Claims 11 and 26 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Li, Wright, Hovenkamp, Huber,
Edwards, Y ani, 9 and Donovan. 10
Improper Markush Grouping:
ISSUE
Does the evidence of record support Examiner's conclusion that
Appellant's claims 14 and 29 contain improper Markush groupings?
ANALYSIS
Appellant discloses a method for producing "emulsion-based
microparticles containing ... [active] agents" (Spec. 1:10-11). Appellant's
independent claims 1, 16, and 43 are each directed to a method of preparing
microparticles comprising, inter alia, active agents (see App. Br. 13, 15, and
17). Appellant's claims 14 and 29 depend directly from Appellant's
independent claims 1 and 16, respectively (see App. Br. 16). Appellant's
Specification defines the term "active agent" as "any biological or chemical
agent" and provides examples of such agents (Spec. 15 :26-27; see also id. at
5:21-35 (providing examples of biological agents); 14:1-8 (providing
examples of chemical agents); 21: 17-19 ("it will be apparent that certain
agents that are both chemically and/or physiologically related may be
substituted for the agents described herein while the same or similar results
would be achieved")).
Thus, all species of Appellant's claimed invention are useful in
preparing microparticles comprising, inter alia, active agents and, therefore,
9 Yanai et al., US 5,846,562, issued Dec. 8, 1998.
10 Donovan, US 2002/0028216 Al, published Mar. 7, 2002.
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Application 14/541,328
share a common use in the preparation of structurally similar microparticles
comprising an active agent (see generally Br. 12). Therefore, we are not
persuaded by Examiner's conclusion that Appellant's claims contain an
improper Markush grouping (see Non-Final Act. 2-3; Ans. 2--4).
CONCLUSION
The preponderance of evidence of record fails to support Examiner's
conclusion that Appellant's claims 14 and 29 contain improper Markush
groupings. The rejection of claims 14 and 29 under the judicially created
doctrine of improper Markush grouping is reversed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Li discloses the preparation of emulsions
utilizing an emulsification device comprising an enclosure
having orifices thereby permitting flow of a fluid through the
enclosure along one of its axis, of any cross-section profile
perpendicular to its axis for fluid flow, which enclosure is
packed with a material which causes the flow of fluids to be
broken down into many fine streams which fine streams, being
in intimate contact one with the other, remix rapidly and
repeatedly, resulting in the formation of the desired emulsion.
The fluids which are mixed in the packed enclosure are fed to
the enclosure by fluid feeding means such as pumps or by
gravity feed tanks and conduits communicatively attached to
the packed enclosure. The fluids fed into the packed enclosure
are introduced into the enclosure in close proximity one to
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another so as to insure maximum intermixing of the different
fluids.
(Li, Abstract; see Non-Final Act. 7.)
FF 2. Li's Figure 1 is reproduced below:
FIGURE!
PACKED TUBE EMULSIFIER
ORGAN!C - INORaANIC
PHASE i>t,ASE
s1L _____
EMllLSIOII
Li's Figure 1:
[I]s a schematic showing a typical packed tube emulsifier which
can be used in the method of the instant invention wherein the
arrow pointing into an opening indicates the entrance ( 1) into
which the immiscible fluids are simultaneously introduced for
passage through the enclosure (3) to the exit (2), indicated by
the arrow pointing away from the enclosure (3), fluid flow
being through the enclosure in the direction resulting from the
indicated mode of fluid introduction. The cross hatching ( 4) in
the enclosure (3) represents the packing filling the enclosure
which may be any of the packings described in greater detail
below and recited as operable in the method.
(Li 1 :58 - 2:2 ( emphasis omitted); see Non-Final Act. 6-7.)
FF 3. Li discloses:
Suitable packing material is selected from the group consisting
of steel metal sponge ... , metal shavings, ceramic chips, Berl
Saddle ... , animal hair or plastic brush, metal tubes shorter
than the internal diameter of the enclosure and mixtures of the
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above, [preferably] metal shavings, metal sponge ( such as
Kurly Kate) and 'Cannon' packing.
(Li 3:12-19; see Non-Final Act. 7; cf Li 3:19-24 ("The proper choice of
packing material is critical since it has been discovered that numerous
seemingly attractive materials will not function to give emulsions. Some
that will not work are perforated glass beads, metal Fenske rings, Raschig
rings (glass), steel wool, [and] wooden straw").)
FF 4. Li discloses that a "packed tube, like Kenics mixer, is a type of static
or motionless mixer, it is much more effective in making high ratio
emulsions than Kenics because of the structure difference between the two
devices," wherein a "packed tube is much more densely packed in a random
manner as compared to Kenics" (Li 5:3--4; see Non-Final Act. 8).
FF 5. Li discloses:
[T]he length of the enclosure from entrance orifices to exit
orifices, the amount of packing, the density of the packing, and
the type of material packed is left to the discretion of the
practitioner, depending on the type of emulsion desired, the
density of the fluids used and the final ratio of internal to
external phase desired.
(Li 3:35--40; Non-Final Act. 7.)
FF 6. Examiner finds, inter alia, that Li "does not expressly teach forming
microparticles using their packed tube emulsifier under laminar flow
conditions[] [or that] the packing material is spherical beads ranging in size
from 20 to 1000 µm" (Non-Final Act. 9)
FF 7. Wright "relates to a method and an apparatus for preparing
microparticles having a selected polymer molecular weight" (Wright 1: 14--
17; see Non-Final Act. 9-10 (Wright discloses, inter alia, "a method for
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preparing microparticles ... using a Kenics static mixer" ( emphasis omitted)
(citing Wright 5:52-57))).
FF 8. Examiner relies upon Hovenkamp to disclose a method of preparing
emulsions, wherein the method "includes a packed bed (static) mixer
wherein the packing media is in the form of sphere packings of glass or steel
spheres, ranging from 70 µm to 40 mm (i.e. 4000 µm) in diameter with
random or regular packing" (Non-Final Act. 10 (emphasis omitted) (citing
Hovenkamp, Abstract and § 1.2).
FF 9. Huber "relates to a process for the analysis of aqueous or non-
aqueous solutions, in which the sample is introduced into a stream of reagent
and the reaction product formed is measured in a suitable detector" (Huber
1:5-9).
FF 10. Huber discloses a process, wherein the reaction is carried out "in a
chromatographic column which is filled with an inert, finely divided
material, e[. Jg. glass beads of from 50 to 200 µm diameter" (Huber 1 :41--44;
see also Non-Final Act. 10 (Examiner relies upon Huber to disclose "a
packed column ... filled with an inert, finely divided material, such as glass
beads having a diameter from 50 µm to 200 µm ... which has a mixing
function")).
FF 11. Edwards:
[P]rovides a process for the dispersion of particulate solids in
liquid media comprising pumping a liquid premix containing an
admixture of said solids and said liquid media through a
plurality of orifices at a laminar flow velocity, there being
sufficient pressure drop across said plurality of orifices to
provide shear energy to cause said dispersion, the orifices being
the network of tortuous paths formed from substantially
nondeformable spherical particles arranged in a series of beds,
each bed consisting of spherical particles of a substantially
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uniform size and comprising at least one coarse bed of particles
having a diameter of at least about 0.5 mm, at least one
intermediate bed of particles having a diameter of about from
0.5 to 0.15 mm, and at least one fine bed of particles having a
diameter of about from 0.15 to 0.05 mm, and wherein the flow
rate of the liquid medium is adjusted to provide a shear rate of
about from 1500 to 6300 sec-1 in each coarse bed, a shear rate
of about from 3300 to 15,000 sec-1 in each intermediate bed,
and a shear rate of about from 10,000 to 3,000 sec-1 in each fine
bed.
(Edwards 1 :56-2:8; see Non-Final Act. 11 (Edwards discloses the use of
"spherical particles of uniform size" "[t]o achieve [packed] beds of uniform
and predictable flow characteristics" (Non-Final Act. 11 ). )
FF 12. Examiner finds that the combination of Li, Wright, Hovenkamp,
Huber, and Edwards fails to suggest the use of "the protein, albumin, as an
emulsion stabilizer" and relies upon Yanai and Donovan to make up for this
deficiency (Non-Final Action 13-14).
FF 13. Zeigerson declares:
Laminar flow and turbulent flow are two different flow
regiments. Laminar flow occurs when a fluid flows in parallel
layers with no disruption between the layers. At low velocities,
there is no lateral mixing of the fluid layers. The conditions that
influence whether a given fluid flow is laminar or turbulent are
the fluid kinematic viscosity, inertial forces ( e.g. fluid velocity),
and dimensional parameters ( e.g. the size of flow path). Lower
fluid viscosity, larger inertial forces and larger dimensional
parameters promote turbulent flow, while laminar flow is
promoted by higher fluid viscosity, smaller inertial forces and
smaller dimensional parameters.
(Zeigerson Dec. 11 ,r 11.)
11 Declaration of Ehud Zeigerson, signed May 1, 2013.
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FF 14. Zeigerson declares that "[ e ]mulsions will not form in an emulsifier
that is designed to produce emulsions under turbulent flow conditions if
operated under laminar flow conditions created by a lower fluid velocity
because in the absence of turbulence no mixing of the phases can occur" (id.
,r 13; see also id. ,r 16 ("[a] high-void fraction packing cannot produce
emulsion under laminar flow conditions because the mixing elements will
not generate turbulence, and as a result the two immiscible fluids will not
mix)).
FF 15. Zeigerson declares that "Li's packed column is an emulsifier that is
designed to promote emulsions under turbulent flow conditions; it is a sub-
type of a turbulent static mixer" (Zeigerson Dec. ,r 13; see also id. ,r 16 (Due
to "the tube packing materials used by Li ... 90% or more of Li's column
volume is void, and 10% or less of the column volume is packing material,"
which "is typical for static mixers that use mixing elements for producing
turbulence. . . . Therefore, the method described by Li is not capable of
producing emulsion under laminar flow conditions")).
ANALYSIS
The rejection over the combination of Li, Wright, Hovenkamp, Huber, and
Edwards:
Each of Appellant's independent claims requires, inter alia, the use of
"a packed bed apparatus under laminar flow conditions" (see App. Br. 13,
15, and 17).
Based on the combination of Li, Wright, Hovenkamp, Huber, and
Edwards, Examiner concludes that, at the time Appellant's invention was
made, it would have been prima facie obvious "to use the packed bed static
mixer of LI as a means for forming the emulsion microparticles of WRIGHT
because LI suggests that the packed bed static mixer is much more effective
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in making high ratio emulsions ... than the Kenics static mixer used by
WRIGHT" (Non-Final Act. 11). In this regard, Examiner reasons:
[O]ne of ordinary skill in the art would have been motivated to
use the spherical beads of HOVENKAMP, HUBER, or
EDWARDS in the packed bed static mixer of LI because[] ... ,
of their availability, low cost, and the ability to construct
uniform beds with predictable flow characteristics, in addition
to easy clean-up[, as suggested by Edwards].
(Id.) We are not persuaded.
Although Examiner recognizes that Li does not disclose the
production of microparticles under laminar flow conditions, Examiner
asserts that because "LI directly suggest[ s] gravity feed tanks as an
alternative to pumps, suggesting a lower flow rate, and criticizes current
emulsification machines as being too powerful[;] ... the emulsion mixing
process described by LI would have reasonably been under laminar flow
conditions" (Non-Final Act. at 8; see Br. 5). Appellant contends, however,
that "even if Li ... lowers the power of its apparatus, laminar flow
conditions would still not be achieved" (Br. 5 ( emphasis omitted) ( citing
Zeigerson Dec. ,r 11); see FF 13). In this regard, Appellant contends that
"[fJluid velocity is just one of the elements in creating laminar flow, and one
cannot reasonably determine that Li ... is operating under laminar flow
conditions based solely on observing fluid velocity alone" (Br. 5 ( emphasis
omitted)).
As Appellant explains, Li's apparatus "is not capable of producing
emulsion under laminar flow conditions because the void ratio of Li's
apparatus would make it a sub-type of a turbulent static mixer" and
"[ e ]mulsions will not form in an apparatus that is designed to produce
emulsions under turbulent flow conditions if operated under laminar flow
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conditions created by lower fluid velocity because in the absence of
turbulence no mixing of the phases occur" in Li's apparatus (Br. 7 ( citing
Zeigerson Dec. ,r 13); FF 13-15). In this regard, Appellant contends that in
contrast to Appellant's declaratory evidence, "Examiner has not provided
any scientific reasoning or evidence that Li et al.' s method uses laminar flow
rather than a turbulent flow" (Br. 5---6; see FF 13-15).
We find that the preponderance of evidence on this record falls in
favor of Appellant. The Specification expressly distinguishes "laminar
flow" conditions from "turbulent flow" (Spec. 4:11-14; see id. at 6:36 ("a
non-turbulent, or laminar flow"); id. at 7:7-8). On this record, Examiner
failed to establish an evidentiary basis to support a conclusion that Li
discloses a process of preparing microparticles under laminar flow
conditions (see FF 6 (Li "does not expressly teach forming microparticles
using their packed tube emulsifier under laminar flow conditions"); cf Non-
Final Act. 8 ("the emulsion mixing process described by LI would have
reasonably been under laminar flow conditions")).
We recognize Examiner's reliance on Wright to disclose the
preparation of microparticles using a Kenics static mixer, which, like Li's
packed tube, "is a type of static or motionless mixer" (FF 4 and 7).
Examiner, however, failed to establish an evidentiary basis on this record to
support a conclusion that Wright discloses a process of preparing
microparticles under laminar flow conditions, namely, Examiner did
establish that a static mixer employs non-turbulent, laminar flow conditions.
Indeed, as argued by Appellants, the Specification teaches that static mixers
are "turbulent mixing devices" (Spec. 2:5-11 ). Thus, Examiner failed to
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establish that the combination of Li and Wright suggests a process for
preparing microparticles under laminar flow conditions.
Examiner relies on the combination of Hovenkamp, Huber, and
Edwards, to suggest packing materials that fall within the scope of
Appellant's claimed invention (FF 8-12). Examiner, however, failed to
establish an evidentiary basis on this record to support a conclusion that a
person of ordinary skill in this art would have found it prima facie obvious
to use the packing materials suggested by the combination of Hovenkamp,
Huber, and Edwards in the device suggested by the combination of Li and
Wright in order to produce microparticles under laminar flow conditions
(see App. Br. 8-9 ("[a] skilled artisan would not have turned to
[Hovenkamp] or Huber if their goal was to make microparticles using
laminar flow conditions") ( emphasis omitted); id. at 9 ("Edwards [] does not
teach making emulsions or microparticles") ).
The rejection over the combination of Li, Wright, Hovenkamp, Huber,
Edwards, Yanai, and Donovan: 12
Appellant's claim 11 depends ultimately from and further limits the
second phase of Appellant's claim 1 to further comprise an emulsion
stabilizer that is albumin.
Based on the combination of Li, Wright, Hovenkamp, Huber,
Edwards, Yanai, and Donovan, Examiner concludes that, at the time
Appellants' invention was made, it would have been prima facie obvious "to
12 We recognize that Appellant provides separate arguments for Appellant's
claims 11 and 26 (see Br. 10-11). Appellant's arguments, however, are the
same for each claim. Therefore, we have considered Appellant's claims 11
and 26 as a single group, wherein claim 11 is representative.
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use albumin as the emulsion stabilizer," as disclosed by the combination of
Yanai and Donovan, in the process of preparing microparticles suggested by
the combination of Li, Wright, Hovenkamp, Huber, and Edwards (Non-Final
Act. 14).
As Appellant explains, however, Yanai and Donovan fail to make up
for the deficiencies in the combination of Li, Wright, Hovenkamp, Huber,
and Edwards discussed above (see App. Br. 10-11).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1, 3, 5-10, 12-16, 19-25, 27-31, 42, and 43
under 35 U.S.C. § 103(a) as unpatentable over the combination of Li,
Wright, Hovenkamp, Huber, and Edwards is reversed.
The rejection of claims 11 and 26 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Li, Wright, Hovenkamp, Huber,
Edwards, Y ani, and Donovan is reversed.
REVERSED
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