Ex Parte Conlisk et al

Patent Trial and Appeal Board

Mar 24, 2017

13195774 (P.T.A.B. Mar. 24, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/195,774 08/01/2011 Albert Terrence Conlisk JR. OSU1159-260C 2547
8698 7590 03/28/2017
STANDLEY LAW GROUP LLP
6300 Riverside Drive
Dublin, OH 43017
EXAMINER
SASS, SARA A
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
03/28/2017 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):
standley docketing @ standleyllp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALBERT TERRENCE CONLISK JR., SUBHRA DATTA,
WILLIAM H. FISSELL, and SHUVO ROY1
Appeal 2015-006061
Application 13/195,774
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims that have
been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants indicate that the real party in interest is The Ohio State
University (subject to assignment), and that a confirmatory license to
National Institutes of Health (NIH), U.S. Dept, of Health and Human
Services (DHHS), and the U.S. Government NIH Division of Extramural
Inventions and Technology Resources (DEITR) is recorded in USPTO
records. (Br. 2.)
Appeal 2015-006061
Application 13/195,774
STATEMENT OF THE CASE
Appellants’ invention relates to “ultrafiltration, and more particularly
. . . selective filtration of charged/uncharged molecules potentially in
biomedical and related applications.” (Spec. 12.)
Claims 2—6, 8—20, 22, and 23 are on appeal. Claim 22 is illustrative:
22. A device for selective ultrafiltration of a fluid containing
molecules of first and a second solute, by selectively retaining
the first solute while passing the second solute, comprising:
a housing;
a main filtration chamber inside the housing;
an inlet port passing through the housing configured to
receive the fluid;
an outlet port passing through the housing configured to
return the fluid to a feed flow;
an ultrafiltration membrane contained in the main
filtration chamber to divide the main filtration chamber into at
least two interior chambers, a first of the at least two interior
chambers being a feed chamber to contain the fluid and a second
of the at least two chambers being a permeate chamber, the
ultrafiltration membrane comprising pores sized to allow passage
of the similarly-sized molecules and establish a sieving
coefficient for each of the first and second solutes across the
ultrafiltration membrane; and
a permeate solution, contained in the permeate chamber,
the permeate solution comprising an additive solute that is
selected so that the presence of the additive solute in the
permeate solution decreases the sieving coefficient of the first
solute across the ultrafiltration membrane relative to the sieving
coefficient of the second solute across the ultrafiltration
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Application 13/195,774
membrane, while the pores render the membrane substantially
impermeable to the additive solute.
(Br. 17—18 (Claims App’x).)
The claims stand rejected as follows:
I. Claims 2—6, 8—20, and 22 under 35 U.S.C. § 103(a) over
Fissell.2
II. Claim 23 under 35 U.S.C. § 103(a) over Fissell and Ross.3
DISCUSSION
REJECTIONS I AND II
These rejections rely upon the Fissell reference, and so we focus on
the Examiner’s findings with respect to this reference.
Appellants’ independent claim 22 recites, among other things,
a permeate solution, contained in the permeate chamber, the
permeate solution comprising an additive solute that is selected
so that the presence of the additive solute in the permeate
solution decreases the sieving coefficient of the first solute across
the ultrafiltration membrane relative to the sieving coefficient of
the second solute across the ultrafiltration membrane, while the
pores render the membrane substantially impermeable to the
additive solute.
Independent claim 17 includes a similar limitation. (Br. 17—18 (Claims
App’x).)
The Examiner finds that
Fissell teaches a device for selective ultrafiltration of a fluid
containing molecules of first and second solute (column 2, lines
2 Fissell, IV et al., US 7,048,856 B2, issued May 23, 2006.
3 Ross, US 2002/0115956 Al, published Aug. 22, 2002.
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Appeal 2015-006061
Application 13/195,774
2-4, column 8, lines 52—57), by selectively retaining the first
solute as antibodies (column 2, lines 6—7) while passing the
second solute as beta 2 micro globulin (column 2, line 8),
comprising: a housing 10 (column 12, lines 55—57), a main
filtration chamber compartment (column 12, lines 50—55) inside
the housing 10, an inlet port/opening entry 602 (column 13, lines
11-15) passing through the housing 10 configured to receive the
fluid (column 13, lines 20-25), an outlet port/exit means on the
600 side (column 13, lines 17—13) passing through the housing
10 (column 12, lines 55—57) configured to return the fluid to a
feed flow as exit of feed fluid (column 13, line 1, Figure 3); and
an ultrafiltration membrane 201 (column 9, lines 34—36, column
10, lines 24—25) contained in the main filtration
chamber/compartment to divide the main filtration chamber into
at least two interior chambers/sub-compartments 700, 702
(column 12, lines 49—55), a first of the at least two interior
chambers being a feed chamber/first sub-compartment 700 to
contain the fluid (column 12, line 67) and a second of the at least
two chambers being a permeate chamber/second sub­
compartment 702 (column 13, lines 5—8), the ultrafiltration
membrane 201 comprising pores capable of separating middle
molecules (column 10, lines 25—27, 34—36, Figure 3). Fissell
further teaches a permeate solution (column 13, line 8),
contained in the permeate chamber/second sub-compartment
(column 13, lines 5—8), the permeate solution comprising an
additive solute as a dialyzing fluid (column 13, line 10) coming
through 102 (Figure 3), selected with regard to both the selected
solute and the ultrafiltration membrane 201 because it is
incorporated into the feed fluid (column 13, lines 10-11), such
that the pores render the membrane 201 substantially
impermeable to the additive because the pores can be adjusted to
be impermeable to various blood components (column 3, lines
50-54, 60-65, Figure 3).
(Ans. 3-4.)
The Examiner finds that
Fissell fails to teach [that] the presence of the additive
solute/dialyzing fluid (column 13, line 10) in the permeate
solution (column 13, line 8) decreases the sieving coefficient of
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Application 13/195,774
the first solute across the ultrafiltration membrane relative to the
sieving coefficient of the second solute across the ultrafiltration
membrane, and that a sieving coefficient is established for each
of the first and second solutes across the ultrafiltration
membrane, because Fissell doesn’t specifically teach a sieving
coefficient.
(Id. at 4.)
The Examiner finds that
Fissell teaches [that] the presence of the additive solute/dialyzing
fluid (column 13, line 10) in the permeate solution (column 13,
line 8) and of different solutes in permeate solution allows for
complete control over parameters (column 9, lines 22—25) that
would determine permeate side and feed side values for solute
diffusion during hemofiltration (column 14, lines 1—2).
Additionally, Fissell teaches a system that permits complete
manipulation of parameters to control exclusion of molecules
with particular properties (column 9, lines 22—25) which would
be necessary for hemofiltration (column 14, lines 1—2),
diagnostic uses (column 15, lines 63—65), bioreactors (column
16, line 42), bioartificial organs (column 16, lines 64—66),
surfaces (column 17, lines 35—36), cells (column 18, lines 20-
24) all of which would require different solutes filtered and
maintained from the feed fluid by the membrane for their specific
application as is known in the art, and thus sieving coefficients
as defined are disclosed. Also, Fissell teaches large molecules
are blocked by the membrane (column 2, lines 6—8) and that
smaller molecules, such as the second solute, beta 2
microglobulin (column 2, lines 7-10) are let through due to their
danger in accumulating for the risk of renal failure (column 2,
lines 10-13).
(Id. at 4—5.)
The Examiner asserts that
[t]he blockage of the first solute, and the allowance of the second
solute, would mean that there would be less receiving stream for
the sieving coefficient for the first solute, and greater receiving
stream for the sieving coefficient for the second solute. This
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Application 13/195,774
would create a decreased sieving coefficient of the first solute
across the ultrafiltration membrane relative to the sieving
coefficient of the second solute across the ultrafiltration
membrane.
Sieving coefficient = S = Cr / Cd
Cr = mean concentration mass receiving stream
(first/second solutes after membrane)
Cd = mean concentration mass donating stream (flow
prior to membrane)
S (antibodies) < S (beta 2 microglobulin) because mass
receiving stream of antibodies is blocked. S (first solute) < S
(second solute).
(Id. at 5—6.)
The Examiner concludes that it would have been obvious to
derive from Fissell’s disclosure of particular solutes traveling
across the ultrafiltration membrane as contributing to the sieving
coefficient values, especially since Fissell is teaching various
components of the system are controlled depending on the
situation in which it is used. The large and small molecule
blocking and allowance described above makes the sieving
coefficient condition recited in the claim obvious over Fissell
after the mathematics, as demonstrated above, are performed.
(Id.)
A prima facie case of obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l 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
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
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Application 13/195,774
We are not persuaded that the Examiner has met the burden to
establish by a preponderance of the evidence that claims 22 and 17 would
have been obvious. Instead, we agree with Appellants that
[a] major contention of the applicant in this prosecution has been
that claim 22 requires a “permeate solution, contained in the
permeate chamber,” with an “additive solute” selected “so that
the presence of the additive solute in the permeate solution
selectively decreases the sieving coefficient of the first solute
across the ultrafiltration membrane relative to the sieving
coefficient of the second solute across the ultrafiltration
membrane, while the pores render the membrane substantially
impermeable to the additive solute.”
The Patent Office maintains that a “third fluid” that is a
“dialyzing fluid for the feed fluid” (both quotes from Fissell
‘856, Col 13, line 10) is qualified as the additive solute. The
Patent Office has failed to establish in a documented fashion that
one of skill would consider a generic term like “dialyzing fluid”
to carry with it the express requirements of the claim.
(Br. 8-9.)
We recognize, but are not persuaded by, the Examiner’s assertion that
[t]he additive solute in the dialyzing fluid for the feed fluid taught
by Fissell is added for optimal fluid composition delivery in the
system taught by Fissell. See column 13, line 10. Fissell teaches
the presence of the additive solute/dialyzing fluid (column 13,
line 10) in the permeate solution (column 13, line 8) and of
different solutes in permeate solution allows for complete control
over parameters (column 9, lines 22—25) that would determine
permeate side and feed side values for solute diffusion during
hemofiltration (column 14, lines 1—2).
(Ans. 15-16.)
We also recognize, but are not persuaded by, the Examiner’s assertion
that
Examiner relied upon the one surface treatment of at least one
pore taught by Fissell (column 4, lines 24—28) which can include
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Application 13/195,774
making the pores impermeable as is known in the art. This
impermeability is obvious over Fissell since Fissell teaches the
dialyzing fluid has its constituents remain with the feed fluid for
an ultrafiltration of blood that supplies nutrients (Col 3, lines 20—
26) as cited in the rejection.
(Id. at 19.)
“Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). ft appears
that the Examiner concludes that because “Fissell teaches the presence of the
additive solute/dialyzing fluid (column 13, line 10) in the permeate solution
(column 13, line 8) and of different solutes in permeate solution allows for
complete control over parameters (column 9, lines 22—25)” (id. at 15—16), it
would have been obvious to modify Fissell by controlling parameters so that
“the pores render the membrane substantially impermeable to the additive
solute” as claimed. The Examiner, however, did not adequately explain how
or why the skilled artisan would have predictably, and with a reasonable
expectation of success, modified Fissell in the manner suggested. Depuy
Spine, Inc v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326 (2009)
(citations omitted) (“the ‘predictable result’ discussed in KSR refers not only
to the expectation that prior art elements are capable of being physically
combined, but also that the combination would have worked for its intended
purpose.”). While Fissell might teach surface treatment of the membrane “to
promote or retard attachment of specific cells and proteins” as the Examiner
points out (Fissell 4:24-28; Ans. 19), we are unpersuaded this teaches or
suggests the structure and function of the additive solute of the claims.
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On the present record, we thus agree with Appellants that “Fissell
’856 does not do anything to characterize the additive solute in a manner that
would allow one of skill in the art to identify an additive solute that would
be reasonably certain to be successfully implemented.” (Br. 10).
Accordingly, on this record, the Examiner failed to establish an
evidentiary basis to support a conclusion that there was an advantage or
reason to modify Fissell’s device so that “the pores render the membrane
substantially impermeable to the additive solute” as required by claim 22,
and similarly required by claim 17.
For the reasons above, the rejection of independent claims 17 and 22
is reversed. The Examiner’s findings with respect to Ross, do not make up
for the deficiencies of Fissell. We thus reverse the rejection of claim 23.
CONCLUSION OF LAW
We reverse the rejection of claims 2—6, 8—20, and 22 under 35 U.S.C.
§ 103(a) over Fissell.
We reverse the rejection of claim 23 under 35 U.S.C. § 103(a) over
Fissell and Ross.
REVERSED
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