Ex Parte Hudson et al

Patent Trial and Appeal Board

Nov 9, 2018

13334154 (P.T.A.B. Nov. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/334, 154 12/22/2011
109357 7590 11/14/2018
Evonik Corporation
Intellectual Property Management
299 Jefferson Road
Parsippany, NJ 07054-0677
FIRST NAMED INVENTOR
Bruce W. Hudson
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.
2011Pl2006 USOl 1246
EXAMINER
BROWE, DAVID
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
11/14/2018 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 BRUCE W. HUDSON,
GARY W. OPPERMAN, and ADRIAN T. RAICHE
Appeal2017-010176
Application 13/334, 154
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1, 2 under 35 U.S.C. § 134 involving claims to a
method of preparing an emulsion. The Examiner rejected the claims as
being of improper dependent form and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b ). We affirm-in-part.
1 Appellants identify the Real Party in Interest as Evonik Corporation (see
App. Br. 1).
2 We have considered and herein refer to the Specification of Dec. 22, 2011
("Spec."); Final Office Action of Aug. 24, 2016 ("Final Act."); Appeal Brief
of Feb. 23, 2017 ("App. Br."); and Examiner's Answer of May 9, 2017
("Ans.").
Appeal2017-010176
Application 13/334, 154
Statement of the Case
Background
"Encapsulation of pharmaceuticals in biocompatible, biodegradable
polymer microparticles can prolong the maintenance of therapeutic drug
levels" (Spec. ,r 3). "Several techniques for the production of microparticles
containing biological or chemical agents by an emulsion-based
manufacturing technique have been reported" (id. ,r 5). The Specification
teaches a need for "a column that is configured to maintain a consistent path
length and to prevent formation of preferred channels in a packed bed during
scale-up of an emulsion process" (id. ,r 9).
The Specification teaches "the column includes at least one divider
positioned within the interior cavity .... the dividers are configured to
partition the packing material and to direct fluid flow through the column"
(Spec. ,r 10).
The Claims
Claims 16-20, 22-24, 27, and 30 are on appeal. Independent claim 16
is representative and reads as follows:
16. A method of preparing an emulsion, the method
compnsmg:
positioning a packing material within a column, the
column having a longitudinal axis and a periphery defining an
interior cavity, the interior cavity having a longitudinal length;
the packing material configured to permit fluid flow through the
column along the longitudinal axis, the column comprising:
an inlet in fluid communication with the interior cavity;
an outlet in fluid communication with the interior cavity;
and
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Application 13/334, 154
at least one divider positioned within the interior cavity,
each divider of the at least one divider extending along at least a
portion of the longitudinal length of the interior cavity,
wherein the at least one divider is configured to partition
the packing material and direct fluid flow therethrough the
interior cavity;
introducing a plurality of fluids through the inlet of the
column under laminar flow conditions, wherein the plurality of
fluids combine within the interior cavity of the column to form
an emulsion product; and
collecting the emulsion product through the outlet of the
column;
wherein the method is insensitive to flow rates; and
wherein the column can be utilized at any pressure.
The Issues
A. The Examiner rejected claim 22 under 35 U.S.C. § 112, fourth
paragraph as being of improper dependent form (Final Act. 2-3).
B. The Examiner rejected claims 16-20, 22-24, 27, and 30 under 35
U.S.C. § I03(a) as obvious over Zeigerson3 (Final Act. 3-7).
A. 35 USC§ 112,fourth paragraph
Dependent claim 19 limits independent claim 16 by reciting a first
phase that comprises a solvent and "an active agent." The Examiner finds
that Markush group of active agents recited in claim 22 does not further limit
the generic active agent recited in claim 19 (see Final Act. 2). Specifically,
the Examiner finds "Claim 22, which depends from claim 19, recites a
3 Zeigerson, US 2007/0190154 Al, published Aug. 16, 2007.
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Application 13/334, 154
Markush group of active agents which is so infinitely broad and generic as to
encompass the entire spectrum of any and all active agents possibly covered
in claim 19" (Final Act. 2). The Examiner finds that "claim 22 provides that
the group of active agents can include any 'organic molecule' and also any
'inorganic molecule', as well as any 'salt' (i.e. organic or inorganic salt)
which alone would thus cover the entire spectrum of active agents known to
man" (id.).
Appellants contend
Claim 22, on the other hand, is directed to the method of claim
19, wherein the active agent of the first phase is specifically
recited. Therefore, claim 22 does further limit the active agent
of claim 19. While claim 22 may cover a sub-generic group of
active agents recited in claim 19, the meets and bounds of the
sub-genus are apparent to one skilled in the art and as such, the
claim is not in violation of any requirement of 35 U.S.C. § 112.
(App. Br. 9).
We agree with the Examiner because, as the Examiner points out,
every molecule is either a salt, an "organic" or an "inorganic" molecule.
That is, the term "organic" is defined as "[ o ]for relating to any covalently
bonded compound containing carbon atoms". 4 Meanwhile, "inorganic" is
defined as "[ n Jot an organic substance; not a hydrocarbon or a derivative of
hydrocarbon."5 Therefore, as the Examiner points out, these two words
4 See Organic. (1992). In C. G. Morris (Ed.), Academic Press Dictionary of
Science and Technology (4th ed.). Oxford, UK: Elsevier Science &
Technology. Retrieved from https://search.credoreference.com/content/
entry/ apdst/ organic/O?institutionid=7 43
5 See Inorganic. (1992). In C. G. Morris (Ed.), Academic Press Dictionary
of Science and Technology ( 4th ed.). Oxford, UK: Elsevier Science &
Technology. Retrieved from https://search.credoreference.com/content/
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Application 13/334, 154
along with the term "salts" reasonably encompass every active agent
because every chemical either contains carbon or lacks carbon or is a salt.
For this reason, claim 22 does not further limit claim 19 because it does not
require a set of active agents that differs from that of claim 19. We,
therefore, affirm this rejection.
B. 35 USC§ 103(a) over Zeigerson
The Examiner finds "Zeigerson discloses a method of preparing an
emulsion" that includes using a packing material in a column with an inlet
and outlet, introducing "fluids through the inlet of the column under laminar
flow conditions," collecting an emulsion product, where the method is
insensitive to flow rates and can be used at any pressure (Final Act. 4--5).
The Examiner acknowledges that Zeigerson "does not explicitly
disclose that the additional material inserted at either end is a divider that
extends along at least a portion of the longitudinal length of the interior
cavity and is configured to partition the packing material" (Final Act 5).
The Examiner finds it obvious
to insert a separate material into the inlet end of the tube, the
separate material being a "divider" that extends along at least a
portion of the longitudinal length of the interior cavity and is
configured to partition the packing material, with the reasonable
expectation that the resulting tube will successfully permit the
separate phases to be introduced individually, albeit
simultaneously, into the packed column through different tubes,
and that the two phases merge inside the column (i.e. further
interior from the entrance of the tube) to form the desired
emulsion product.
entry/ apdst/inorganic/O?institutionld=7 4 3
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Application 13/334, 154
(Final Act. 6).
Appellants contend "Zeigerson' s disclosure that separate phases can
be introduced individually into the packed column does not render obvious
the use of dividers to partition the packing material because the two phases
nevertheless subsequently merge inside the column and travel through
column without any dividers" (App. Br. 4). Appellants point out "there is no
teaching anywhere in the general knowledge of the art that teaches such a
divider material" (id. at 5).
Appellants contend a "skilled artisan would not contemplate that the
enclosure of Zeigerson could indicate both an enclosure cap and a partition
or divider that would further partition or divide the interior cavity of the
column" (App. Br. 6). Appellants contend
One of ordinary skill in the art would not obviously recognize
that the best way to keep the two distinct phases flowing on
divided pathways within the packed column until the proper
merge point is to insert a divider. A divider was not taught or
suggested by the cited prior art, and it was only with the benefit
of improper hindsight reasoning after reading Appellants' own
disclosure that a rejection was formulated.
(App.Br. 7).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Zeigerson renders obvious the
use of a "divider positioned within the interior cavity" of a column for
emulsion preparation as required by claim 16?
Findings of Fact
1. The Specification teaches "the column 10 can further comprise
an inlet screen attached to the inlet of the column and an outlet screen
attached to the outlet of the column, and the at least one divider can be
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Application 13/334, 154
secured thereto at least one of the inlet screen and the outlet screen" (Spec.
if 45).
2. Zeigerson teaches "a process for preparing an emulsion that
produces microparticles containing biological or chemical agent" (Zeigerson
if 17).
3. Zeigerson teaches "a packed bed apparatus for the production
of microparticles through an emulsion-based technique. . . . [that] may
further provide a material capable of insertion into both ends for enclosure
of materials in such apparatus" (Zeigerson ,r 41 ).
4. Zeigerson teaches the process "is insensitive to flow rates
within the laminar flow region" and "may be utilized at any pressure
compatible with the equipment utilized" (Zeigerson ,r,r 45, 51 ).
5. Zeigerson teaches
Microparticle size distribution may be manipulated by altering
the packing material size, shape and type; rearranging the inlet
or outlet enclosures; alteration of the physical properties of the
first, second or third phases; altering the length or width of the
vessel and the like. For example, the final microparticle size
can be determined by the size of the packing material, such as
the diameter of a glass bead. Additionally, the length of the
vessel may directly affect the particle size distribution.
(Zeigerson ,r 47).
6. Zeigerson teaches a "feed vessel may be utilized in the present
invention to hold the first or second phases" and that a "tube may run from
each [ feed vessel] through a pump and later merge with the tube from the
other one to the entrance to the packed bed apparatus. The merge may also
happen ... inside the packed bed apparatus itself' (Zeigerson ,r 57).
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7. Figure 2A of the Specification is reproduced below:
18
~10
Flow
FIG. 2A
"Figure 2A is a perspective view of an exemplary column having dividers"
(Spec. ,r 14).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992).
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
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Application 13/334, 154
claimed new invention does." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
We have interpreted a "divider" to mean a physical structure that
partitions a least a portion of a column, e.g., see Fig. 2A (FF 7). This is
consonant with both the Specification and with the ordinary meaning of the
term "divider" as "something serving as a partition between separate spaces
or areas."6
We therefore agree with Appellants that a "divider was not taught or
suggested by the cited prior art, and it was only with the benefit of improper
hindsight reasoning after reading Appellants' own disclosure that a rejection
was formulated" (App. Br. 7).
The Examiner does not provide evidence that dividers were expressly
taught by Zeigerson, and we note the Examiner expressly acknowledges that
"Zeigerson does not explicitly disclose that the additional material inserted
at either end is a divider" (Ans. 5).
Also, the Examiner does not provide evidence that dividers were
inherently taught by Zeigerson. In particular, the Examiner does not
establish that the inlets of Zeigerson extended into the interior cavity. That
is, while Zeigerson may well suggest the use of two separate inlets that
merge "inside the packed bed apparatus" (FF 6), Zeigerson does not
demonstrate that this merger results in a divider because the merger may
reasonably occur in a single tube prior to entry into the packed bed inside the
apparatus. "Inherency ... may not be established by probabilities or
6 See, e.g., https://www.merriam-webster.com/dictionary/divider.
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possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v.
Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
Lastly, the Examiner does not provide a persuasive reason for the
inlets of Zeigerson to extend into the packing bed and serve to partition at
least a portion of the column, nor does the Examiner provide a persuasive
reason to include dividers based on the express disclosure of Zeigerson. Nor
has the Examiner provided any other reason from Zeigerson that would
suggest that an implicit motivation to combine exists because "the
'improvement' is technology-independent and the combination of references
results in a product or process that is more desirable, for example because it
is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more
efficient." DyStar Textilfarben GmbH & Co. Deutschland KG v. CH
Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006). In contrast, Appellant
has provided reasons why dividers would not have been included based on
Zeigerson, including the argument that "one skilled in the art would not be
motivated to include such a divider when Zeigerson already demonstrates
superior results. Zeigerson teaches the production of emulsion-based
microparticles that provides narrow, reproducible, particle size distribution"
(App. Br. 6).
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Zeigerson renders obvious the use of a "divider positioned within the
interior cavity" of a column for emulsion preparation as required by claim
16.
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SUMMARY
In summary, we affirm the rejection of claim 22 under 35 U.S.C.
§ 112, fourth paragraph as being of improper dependent form.
We reverse the rejection of claims 16-20, 22-24, 27, and 30 under 35
U.S.C. § 103(a) as obvious over Zeigerson.
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-IN-PART
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