Ex Parte Dunfield et al

Board of Patent Appeals and Interferences

Jun 30, 2009

10375399 (B.P.A.I. Jun. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_________________

Ex parte JOHN STEPHEN DUNFIELD
and JAMES W. AYRES

Appellants
_________________

Appeal 2009-002435
Application 10/375,399
Technology Center 1600
_________________

Decided1: June 30, 2009
_________________

Before RICHARD TORCZON, SALLY GARDNER LANE and MICHAEL
P. TIERNEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134, is from a Final Rejection of claims
39-48. Claims 1-38 have been withdrawn as being drawn to non-elected
subject matter. (App. Br. 5). Claims 49 and 50 have been cancelled. (App.
Br. 5). We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellants claim a “fluid-jet pen” system containing reagents for
emulsions, microemulsions, or liposomes that contain bioactive agents.
The Examiner relied on the following patent documents:
Name Number Date
Eley 5,320,906 June 14, 1994
Shechter 5,720,551 February 24, 1998
Parazak 6,102,996 August 15, 2000
The Examiner also relied on:
Stimpson et al., Parallel Production of Oligonucleotide Arrays Using
Membranes and Reagent Jet Printing, 25 BioTechniques 886-90 (1998)
(“Stimpson”).
The Examiner rejected claims 39-47 under 35 U.S.C. § 102(b) over
Parazak. We focus on claim 39 as a representative claim. See 37 C.F.R.
§ 41.37(c)(1)(vii). Appellants argued for the separate patentability of
claims 45 and 46.
The Examiner rejected claims 39-43 and 45-47 under 35 U.S.C.
§ 102(b) over Shechter. We focus on claim 39 as a representative claim.
See 37 C.F.R. § 41.37(c)(1)(vii). Appellants argued for the separate
patentability of claims 45 and 46.
The Examiner rejected claims 39-48 under 35 U.S.C. § 103(a) over
Shechter by itself or in combination with Eley. We focus on claim 39 as a
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representative claim. See 37 C.F.R. § 41.37(c)(1)(vii). Appellants argued
separately for the patentability of claims 45 and 48.
The Examiner rejected claims 39-48 under 35 U.S.C. § 103(a) over
Stimpson and Shechter. We focus on claim 39 as a representative claim.
See 37 C.F.R. § 41.37(c)(1)(vii). Appellants argued separately for the
patentability of claims 45, 46, and 48.
The Examiner rejected claims 39-48 under 35 U.S.C. § 103(a) over
Stimpson and Parazak. We focus on claim 39 as a representative claim. See
37 C.F.R. § 41.37(c)(1)(vii). Appellants argued separately for the
patentability of claim 45.
II. LEGAL PRINCIPLES
“Anticipation requires a showing that each limitation of a claim is
found in a single reference, either expressly or inherently.” Atofina v. Great
Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006).
“When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the
product not of innovation but of ordinary skill and common sense.” KSR
Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007).
III. FINDINGS OF FACT
1. Appellants’ claim 39 recites:
A bioactive agent release system, comprising a fluid-jet pen
including ink-jet architecture containing:
(a) a bioactive agent; and
(b) a release agent,
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wherein the fluid-jet pen is configured for jetting the bioactive agent
and the release agent, resulting in an association of an emulsion,
microemulsion, or liposome between the bioactive agent and the
release agent for delivery to a biological system.

(App. Br. 24, Claims App’x).
2. Appellants’ claim 45 recites: “A system as in claim 39, wherein
the association is produced during jetting.” (App. Br. 25, Claims App’x).
3. Appellants’ claim 46 recites: “A system as in claim 39, wherein
the bioactive agent and the release agent are in two separate phases within
the fluid-jet pen.” (App. Br. 25, Claims App’x).
4. Appellants’ claim 48 recites: “A system as in claim 39, wherein
the fluid-jet pen containing a bioactive agent; and a release agent are
packaged in a sterile environment, thereby providing a sterile association
upon jetting.” (App. Br. 25, Claims App’x).
5. Appellants’ specification explains that
“[f]luid-jet pen” includes pen architecture that is substantially
similar or the same as that found in the ink-jet arts. . . .
Modification, if desired, may include design to induce
turbulence, multiple fluidic coupling channels which may have
mixing chambers, break-up baffles, stirring members,
turbulence inducing design, and other mixing structures
generally not present in ink-jet pens. No ink per se is typically
jetted, though ink may be included as a marker in a formulation
along with bioactive material.

(Spec. 7, ll. 15-24).
6. Appellants’ specification defines “bioactive agent” as “organic
and inorganic drugs, as well as other agents such as proteins and peptides,
that are biologically active when introduced to a biological system.” (Spec.
7, ll. 25-27). Appellants’ specification includes therapeutics and diagnostics
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as “bioactive agents,” but does not exclude any specific agents or types of
agents that are biologically active. (Spec. 7, l. 27, through 8, l. 3).
7. Appellants’ specification states that it incorporates by reference
the bioactive agents listed in US Patent 4,649,043 (Spec. 7, ll. 29-31), which
include toxic agents such as anti-parasitic agents and methotrexate (US
Patent 4,649,043 col. 6, ll. 4 and 25-26).
8. Appellants’ specification defines a “release agent” as “any
substance that can be jetted with a bioactive agent that results in an
association between the bioactive agent and the release agent. Liposome-
forming compositions as well as emulsion-forming compositions are
included as release agents.” (Spec. 8, ll. 22-25).
Parazak
9. Parazak provides Examples VI and VII describing emulsion
and microemulsion inks that are added to an ink jet cartridge for printing.
(Parazak col. 19, ll. 19-21 and 40-42).
10. Parazak teaches including biocides, fungicides, and/or
slimicides as additives in the ink. (Parazak col. 16, ll. 48-51).
Shechter
11. Shechter teaches a system for making an emulsification by
jetting a fluid. (Shechter abstract).
12. Shechter teaches that the system can be used to make
pharmaceutical emulsions. (Shechter col. 4, ll. 59-61).
13. Shechter teaches that
[e]mulsification is achieved by directing a jet of fluid along a
first path, and interposing a structure in the first path to cause
the fluid to be redirected in a controlled flow along a new path,
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the first path and the new path being oriented to cause shear and
cavitation in the fluid.

(Shechter abstract).
14. Shechter teaches that emulsions generally “compris[e] two
immiscible liquid phases, with one phase dispersed as small droplets in the
other phase.” (Shechter col. 1, ll. 6-7).
15. Shechter teaches that “[j]et-ink printing has similar
requirements of size and distribution,” as other applications that use
emulsions. (Shechter col. 1, ll. 22-23).
Stimpson
16. Stimpson teaches jetting a solution containing DNA from an
ink jet cartridge, by removing the ink and adding a DNA solution to the
entry port of the jet head. (Stimpson 886).
Eley
17. Eley teaches the use of liposomes as delivery as in vivo
delivery systems that are biologically compatible. (Eley col. 1, ll. 41-46).
IV. ISSUES AND ANALYSIS
Appellants claim a system that jets a “bioactive agent” as an emulsion,
microemulsion, or liposome. The system comprises a “fluid-jet pen.” (FF
1). According to Appellants’ specification, a “‘fluid-jet pen’ includes pen
architecture that is substantially similar or the same as that found in the ink-
jet arts” (FF 5) and which may include features such as “mixing chambers,
break-up baffles, stirring members, turbulence inducing design, and other
mixing structures generally not present in ink-jet pens.” (FF 5). However,
Appellants’ specification does not define a “fluid-jet pen” as having these
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features nor do Appellants claim such features. See In re Prater, 415 F.2d
1393, 1405 (CCPA 1969) (“We are not persuaded by any sound reason why,
at any time before the patent is granted, an applicant should have limitations
of the specification read into a claim where no express statement of the
limitation is included in the claim.”). Thus, we understand Appellants
claims to be directed to a fluid-jet pen like those found in the ink-jet arts,
containing any bioactive agent and release agent where upon jetting, an
emulsion, microemulsion or liposome containing the bioactive and release
agents is formed.

Parazak
Issues:
Does Parazak teach a system that “results in” the jetting of an
emulsion, as claimed?
Does Parazak teach a system that is suitable for delivery of a
“bioactive agent” to a biological system, as claimed?
Analysis:
Parazak teaches an ink-jet system that jets an emulsion or
microemulsion. (FF 9). The inks jetted in Parazak can include biocides,
fungicides, and/or slimicides (FF 10).
Appellants argue that Examples VI and VII of Parazak teach forming
an emulsion or microemulsion before it is added to the ink-jet cartridge for
jetting, while claim 39 requires that the “jetting creates an association that is
an emulsion, microemulsion, or liposome for delivery to a biological
system.” (App. Br. 12). Claim 39 requires that “the fluid-jet pen is
configured for jetting the bioactive agent and the release agent, resulting in
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an association of an emulsion, microemulsion, or liposome . . . .” (FF 1
(emphasis added)). Thus, if a “fluid-jet pen” makes an emulsion, that is,
“results in” an emulsion, it falls within the scope of the claim. Claim 39
does not limit the way that the emulsion is made. Claim 39 is not directed to
a method of making emulsions and thus does not require any specific order
of steps. Furthermore, as claim 45 depends from claim 39, and recites a
system that produces the association “during jetting” (FF 2), there is a
presumption that claim 39 is broader in scope and is not limited to producing
the association during jetting. See Beachcombers v. Wildewood Creative
Products, Inc., 31 F.3d 1154, 1162 (Fed. Cir. 1994) (rejecting the
construction of a dependent claim as having the same scope as the claim
from which it depends because it would render the dependent claim
“superfluous”).
Given the scope of claim 39, Parazak teaches a system that “result[s]
in” an emulsion being jetted from the pen, even though the emulsion is
formed before being added to the ink-jet pen. Accordingly, Appellants have
not persuaded us that Parazak does not teach this limitation of the system
recited in claim 39.
Appellants also argue that “Parazak does not teach a system for
creating associations of bioactive agents for delivery to a biological system”
(App. Br. 12), because “Parazak is directed to inks, which are not suitable
for biological systems” (id. (emphasis in original)). As we understand it,
there are two prongs to Appellants’ argument: (1) Parazak does not teach
bioactive agents (App. Br. 13) and (2) Parazak does not teach delivery to a
biological system (id.). Regarding the first prong, Appellants’ specification
defines “bioactive agent,” as “includ[ing] organic and inorganic drugs, as
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well as other agents such as proteins and peptides, that are biologically
active when introduced into a biological system.” (FF 6). Appellants’
definition does not exclude the toxic biocides, fungicides, and slimicides
taught in Parazak as additives to ink. (FF 10). In fact, Appellants’
specification incorporates toxic agents listed in US Patent 4,649,043 by
reference, including anti-parasitic agents and methotrexate. (FF 7).
Appellants’ arguments against the agents recited in Parazak would apply to
those agents as well. Thus, we are not convinced that the biocides,
fungicides, and slimicides recited in Parazak fall outside the scope of the
“bioactive agents” recited in Appellants’ claim 39.
We also note that Appellants do not exclude ink from their claims.
Mars, Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1375 (Fed. Cir. 2004) ("like the
term 'comprising,' the terms 'containing' and 'mixture' are open-ended.").
Furthermore, Appellants’ specification itself acknowledges that “ink may be
included as a marker in a formulation along with bioactive material.”
(FF 5).
As to the second prong, Appellants assert that “suitability for delivery
to a biological system is a limitation of the claim” (App. Br. 13 (emphasis in
original)), but that “the agents in Parazak work in the fluid reservoir before
being jetted onto a surface. Consequently, there is no teaching that the
biocides, even if considered bioactive agents, are configured for delivery at
all.” (Id.). Appellants do not point to structural features that are lacking
from the system taught in Parazak that would prevent delivery to a
biological system. Nor do Appellants point to structural limitations of the
claimed system that make it particularly suited for delivery to a biological
system. “It is well settled that the recitation of a new intended use for an old
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product does not make a claim to that old product patentable.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Accordingly, we are not
persuaded by Appellants’ arguments that Parazak does not teach each
limitation recited in claim 1. See Atofina, 441 F.3d at 999.
Appellants argue for the separate patentability of claim 45, which
requires that the “association is produced during jetting.” (App. Br. 14). As
discussed above, claim 45 limits the system to one that uses jetting to
produce an emulsion. We agree that Parazak only teaches jetting systems
that receive premade emulsions for delivery. Accordingly, the Examiner
erred in rejecting claim 45 as being anticipated by Parazak.
Appellants also argued for the separate patentability of claim 46,
which requires the bioactive agent and the release agent to be in separate
phases within the fluid-jet pen. (FF 3). Emulsions generally include two
separate phases, thus separating the bioactive agent from the release agent.
(See FF 14). Thus, two phases of immiscible liquid would exist before,
during, or after the emulsion was formed in the apparatus taught by Parazak.
Accordingly the Examiner did not err in rejecting claim 46 as anticipated by
Parazak.
Conclusion:
Parazak teaches a system that “results in” jetting of an emulsion and
that that is suitable for delivery of a “bioactive agent,” as claimed.

Parazak and Stimpson
Even if Appellants’ had limited “bioactive agent” to exclude the toxic
agents recited in Parazak, the combination of Parazak and Stimpson would
have rendered the system recited in claim 39 obvious. Stimpson teaches that
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a DNA solution, which is a bioactive reagent, can be jetted from an ink-jet.
Those of skill in the art would have expected that the DNA solution could
have been added to the emulsions of Parazak to achieve precise jetting of a
DNA emulsion. See KSR 550 US at 421.
Appellants argue that “Parazak is directed to inks, which are not
suitable for delivery to biological systems.” (App. Br. 21). As discussed
above, we are not persuaded that the delivery of ink indicates unsuitability
for biological systems.
Appellants argue for the separate patentability of the systems recited
in claims 45 and 46. As discussed above, we agree with Appellants that
Parazak does not anticipate the system of claim 45. Stimpson does not cure
the deficiencies of Parazak, thus the rejection over Parazak and Stimpson
was in error. Claim 46, though, is anticipated by Parazak. As explained
above for the bioactive agents taught in Parazak, the DNA solution of
Stimpson would be in a separate phase from the release agent in an emulsion
of Parazak. Thus, there is no error in the rejection of claim 46 over Parazak
and Stimpson.

Shechter
Issue:
Does Shechter teach a system that comprises a “fluid-jet pen” to form
an emulsion, as claimed?
Analysis:
The Examiner rejected claims 39-43 and 45-47 under 35 U.S.C.
§ 102(b) over Shechter. Shechter teaches an apparatus that jets fluid to
create an emulsion. (FF 11). This fluid is a “release agent,” as claimed,
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because Appellants’ specification defines “release agent” as any substance
that can be jetted to form an emulsion or liposome. (FF 8). Shechter also
teaches that the emulsions can be pharmaceutical emulsions (FF 12), which
would include a “bioactive agent.” (See FF 6). Therefore, Shechter
anticipates a system that produces an emulsion with a bioactive agent by
jetting. See Atofina, 441 F.3d at 999.
Appellants argue that Shechter does not teach a “fluid-jet pen
including ink-jet architecture” as recited in claim 39 because, according to
Appellants, “ink-jet architecture” had special meaning to those in the art, for
example, having micro-fluidic channels and printheads. (App. Br. 14-16).
Appellants argue that the apparatus of Shechter differs from the claimed
system because “Shechter discloses a method of creating an emulsion using
an emulsifying cell having an intricate design.” (App. Br. 15). Appellants
do not support their understanding of an “emulsifying cell” or a “fluid-jet
pen” with language from the specification or with declaratory support from
one of skill in the art about what those terms meant to those in the art at the
time of filing. “Argument of counsel cannot take the place of evidence
lacking in the record.” Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA
1977). Accordingly, Appellants have not persuaded us that the apparatus
taught in Shechter does not fall within the scope of the claimed system.
Appellants argue for the separate patentability of claim 45, which
recites the system of claim 39, “wherein the association is produced during
jetting.” (FF 2). According to Appellants, Shechter “does not teach creation
of an association by the action of jetting in and of itself. In fact, additional
mixing mechanisms are used to actually create the emulsion in Shechter,
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namely, surface features that produce shear and cavitation when the fluid
contacts them.” (App. Br. 16). Shechter teaches that
[e]mulsification is achieved by directing a jet of fluid along a
first path, and interposing a structure in the first path to cause
the fluid to be redirected in a controlled flow along a new path,
the first path and the new path being oriented to cause shear and
cavitation in the fluid.

(FF 13 (emphasis added)). Without jetting, the fluid would not follow the
paths and redirections set out by the surfaces of Shechter and would not
form an emulsion. Accordingly, we are not persuaded that the emulsion is
not produced during jetting in Shechter.
Appellants also argue for the separate patentability of claim 46. (App.
Br. 16-17). As discussed above, in regard to the rejection of claim 46 over
Parazak, the two phases of an emulsion would exist before, during, or after
the emulsion is formed. Thus, we are not persuaded that Shechter does not
teach the limitations recited in Appellants’ claim 46.
In summary, we are not persuaded that the Examiner erred in rejecting
claim 39, or claims 45 and 46 under 35 U.S.C. § 102(b) over Shechter.
Conclusion:
Shechter teaches a system that comprises a “fluid-jet pen” to form an
emulsion, as claimed.

Stimpson and Shechter
The Examiner rejected claims 39-48 over Stimpson and Shechter
under 35 U.S.C. § 103(a). Stimpson teaches using a thermal ink-jet printer
to deliver bioactive DNA solution from the printer head (FF 16). Because
Shechter teaches that emulsions and inks for ink-jet printers have similar
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requirements, such as uniform droplet size (FF 15), those of skill in the art
would have expected that delivering bioactive emulsions from the apparatus
of Shechter, as from the apparatus of Stimpson, would be successful. See
KSR, 550 US at 421.
Appellants disagree, arguing that the “emulsifying cell in Shechter
comprises fitted mechanical members in which emulsions are created by
jetting fluid to create contact with surface features.” (App. Br. 20).
Appellants do not explain why those of skill in the art would not have
expected ink-jet printers without these “fitted mechanical members” (as
shown in Stimpson) to be able to create emulsions. The criterion for
combining references is “not whether the references could be physically
combined but whether the claimed inventions are rendered obvious by the
teachings of the prior art as a whole.” In re Etter, 756 F.2d 852, 859 (Fed.
Cir. 1985). Appellants have not persuaded us that those of skill in the art
would not have considered combining the emulsifying cells of Shechter to
deliver bioactive emulsions to be obvious, even if the cells of Shechter
included “fitted mechanical members.”
Appellants argue for the separate patentability of claims 45, 46, and
48. We have discussed Appellants arguments regarding claims 45 and 46,
above, and found them unpersuasive over Shechter alone. The same
reasoning applies to the combination of Shechter and Stimpson. Claim 48
recites the system of claim 39, “wherein the fluid-jet pen containing a
bioactive agent; and a release agent are packaged in a sterile environment,
thereby providing a sterile association upon jetting.” (FF 4). Appellants
argue that neither Shechter nor Stimpson teach packaging for any purpose.
(App. Br. 21). We are not persuaded that those in the art would not have
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used common sense to produce the pharmaceutical emulsions of Shechter
sterilely. See KSR, 550 US at 420 (“Common sense teaches . . . that familiar
items may have obvious uses beyond their primary purposes . . . .”).
Accordingly, the Examiner did not err.

Shechter and Eley
Eley teaches liposomes that can be used to deliver drugs in biological
systems. (FF 17). The combination of Shechter and Eley would have taught
a system comprising a fluid-jet pen, which can jet liposomes, and that these
liposomes were known in the art to be capable of containing bioactive drugs.
Appellants argue that Shechter does not teach a “fluid-jet pen,” and
that Eley does not cure this deficiency. (App. Br. 18-19). As discussed
above, Shechter teaches an apparatus meeting the claimed limitations. Thus,
we are not persuaded that the combination of Shechter and Eley does not
render the claimed system obvious.
Appellants also argue for the separate patentability of claims 45, 46,
and 48. (App. Br. 19). The merits of these arguments have been addressed
above and were not found to be persuasive.
Accordingly, the rejection of claims 39-48 over Shechter and and Eley
was not in error.
V. ORDER
Upon consideration of the record and for the reasons given,
the rejection of claims 39-46, and 47 under 35 U.S.C. § 102(b) over
Parazak is AFFIRMED;
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the rejection of claim 45 under 35 U.S.C. § 102(b) over Parazak is
REVERSED;
the rejection of claims 39-43 and 45-47 under 35 U.S.C. § 102(b) over
Shechter is AFFIRMED;
the rejection of claims 39-48 under 35 U.S.C. § 103(a) over Shechter
by itself or in combination with Eley is AFFIRMED;
the rejection of claims 39-48 under 35 U.S.C. § 103(a) over Stimpson
and Shechter AFFIRMED;
the rejection of claims 39-48 under 35 U.S.C. § 103(a) over Stimpson
and Parazak is AFFIRMED; and
the rejection of claim 45 under 35 U.S.C. § 103(a) over Stimpson and
Parazak is REVERSED.

No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

saw

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