Ex Parte Straeffer et al

Patent Trial and Appeal Board

Apr 26, 2016

10871694 (P.T.A.B. Apr. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/871,694 06/17/2004 Gregory Straeffer
42754 7590 04/26/2016
Nields, Lemack & Frame, LLC
176 E. Main Street
Suite #5
Westborough, MA 01581
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.
MCA-683 3911
EXAMINER
KURTZ, BENJAMIN M
ART UNIT PAPER NUMBER
1778
MAILDATE DELIVERY MODE
04/26/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte GREGORY STRAEFFER, DAVID P. YAVORSKY,
LEONARD D. DECOSTE, JR., and RALPH STANKOWSKI
Appeal2014-000178
Application 10/871,694
Technology Center 1700
Before PETER F. KRATZ, BEVERLY A. FRANKLIN, and
MARK NAGUMO, Administrative Patent Judges.
KRATZ, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134 from the
Examiner's final rejection of claims 1, 3, 8, 13-16, and 18-24. 1 We have
jurisdiction pursuant to 35 U.S.C. § 6.
Appellants' claimed invention is directed to a disposable integral filter
unit for filtering biopharmaceutical fluids.
Claims 1 and 3 are illustrative and reproduced below:
1. A disposable integral filter unit for filtering biopharmaceutical
fluids, having an inlet and an outlet, and comprising a plurality of filter
1 A PTAB decision affirming the Examiner's rejections in Appeal No. 2014-
000123 (Application No. 11/148,846) was entered on December 31, 2015.
The latter appeal is identified by Appellants as a related appeal (App. Br. 3).
Appeal2014-000178
Application 10/871,694
plates interposed between a pair of end plates; each of said filter plates
comprising a thermoplastic framework, the framework having an outer and
an inner wall, the framework having at least three non-overlapping zones, an
inlet zone, a filtration zone and an outlet zone and a deep gradient filter
packet formed of a thick stratified arrangement of filtration material forming
a composite pad-like structure, wherein the packet comprises a plurality of
layers of filtration material and the permeability of the first filtration layer of
the packet being greater than the permeability of the last filtration layer of
the packet, the packet being selected from the group consisting of a self
supporting structure and a unitized structure encapsulated within a porous
outer material selected from the group consisting of an envelope, a sieve and
a screen and the packet is embedded in the inner wall of said thermoplastic
framework in the filtration zone;
the filter and end plates forming a substantially fixed integral stack,
wherein fluid entering the disposable integral filter unit through said inlet
passes through the deep gradient filter packet of each filter plate
substantially contemporaneously prior to exiting said unit through said
outlet.
3. The disposable integral filter unit of claim 1, wherein the deep
gradient filter packet comprises three layers of filtration material, and
wherein:
(a) the first layer of filtration material is composed of cellulose and
diatomaceous earth, and has a permeability of approximately 1800 LMH/psi;
(b) the second layer of filtration material is composed of cellulose and
diatomaceous earth, and has a permeability of approximately 300 LMH/psi;
and
( c) the third layer of filtration material is a microporous membrane,
and has a permeability of approximately
200 LMH/psi.
The Examiner relies on the following prior art references as evidence
in rejecting the appealed claims:
Gutman
Thiele
Pearl
us 5,429,742
us 5,766,288
us 5,922,200
2
July 4, 1995
June 16, 1998
July 13, 1999
Appeal2014-000178
Application 10/871,694
Murkute
Strohm
US 2004/01888339 Al Sept. 30, 2004
US 6,827,851 Bl Dec. 7, 2004
The Examiner maintains the following grounds of rejection:
1. Claims 1, 8, 14--16, 18-20, and 22-24 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Gutman in view of Thiele.
2. Claims 13 and 21 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Gutman in view of Thiele and Murkute.
3. Claims 1, 3, 14--16, and 19 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Pearl in view of Strohm and Thiele.
4. Claims 8, 18, 20, and 22-24 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Pearl in view of Thiele.
5. Claims 13 and 21 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Pearl in view of Strohm, Thiele, and Murkute.
We affirm the stated rejections substantially for the reasons set forth
by the Examiner in the final rejection and in the Answer. We add the
following for emphasis.
Rejections 1 and 2
Appellants argue against Rejections 1 and 2 together. Appellants
present substantially the same argument in arguing against the claims subject
to Rejection 1 and the claims subject to Rejection 2 (Br. 13-20).
Accordingly, we select claim 1 as the representative claim on which we
decide this appeal as to Rejection 1. Our disposition of Rejection 2 follows
from our disposition of Rejection 1 because Appellants do not present any
additional argument with respect to the claims subject to Rejection 2.
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In particular, Appellants traverse the Examiner's obviousness
rejections based on the Examiner's reliance on Thiele, in combination with
Gutman, for suggesting to one of ordinary skill in the art the use of a deep
gradient type of filter packet in Gutman, as required by representative claim
1, as well as non-separately argued claim 13 subject to Rejection 2 (Br. 13-
20; Final Rej. 2-7).
Appellants present two arguments: (1) Thiele represents non-
analogous art and would not have been considered for a modification of
Gutman by one of ordinary skill in the art; and (2) even if Thiele was taken
as available analogous prior art, there is no motivation for one of ordinary
skill in the art to modify Gutman based on the additional teachings of Thiele
(Br. 13-19).
Neither argument is indicative of harmful error in the Examiner's
obviousness rejection for reasons substantially as presented by the
Examiner.
The two separate tests for determining whether a prior art reference is
analogous are: (1) whether the art is from the same field of endeavor,
regardless of the problem addressed; and (2) if the reference is not within the
inventor's endeavor, whether the reference is reasonably pertinent to the
particular problem with which the inventor is involved. In re Bigio, 381
F.3d 1320, 1325 (Fed. Cir. 2004).
Appellants maintain that Thiele is not analogous prior art principally
because the field of endeavor and problem to be solved of the claimed filter
are contextually indicated/defined by the field of use limitation "for filtering
biopharmaceutical fluids" and the limitation respecting "parallel" flow as set
forth in the Specification , as well as the asserted water tightness and
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structural and functional integrity requirements that are argued to be
required/implied by the claimed subject matter (Br. 13-19; claim 1; Spec. 1-
2). The biopharmaceutical fluid filtering field of endeavor recited in the
appealed invention is asserted to be markedly different than the air filtering
field of use of Thiele and the associated teachings of Thiele are argued to be
limited to addressing problems/considerations that are different than the
problems with which the inventors were involved (Br. 13-19).
In so arguing, Appellants cite to case law, including In re Klein, 647
F.3d 1343 (Fed. Cir. 2011) and the different factual circumstances at issue
therein, in an attempt to define the field of endeavor and/or the problem
addressed more narrowly for their claimed invention at issue here under the
present factual circumstances in advocating for the exclusion of Thiele from
the available prior art for determining the obviousness of the claimed subject
matter (Br. 14 ).
We concur with the Examiner that Appellants' argument does not
serve to indicate or establish that Thiele is non-analogous art (Ans. 2--4).
For instance and as pointed out by the Examiner, the claims are not limited
to filtering a specified type of biopharmaceutical fluid, such as cell cultures,
and providing for any particular cleanliness, sterilization, or validation
requirements, and the subject Specification does not furnish a particular
definition for a biopharmaceutical fluid (Ans. 2).
Rather and as determined by the Examiner, the Specification provides
that Appellants' "invention is directed to disposable filter units, and in
particular, to a disposable integral filter unit through which fluid flows in
'parallel' through a plurality of deep gradient filter packets" (Spec. 1; Ans.
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3).2 The Specification discloses that a deep gradient filter packet "comprises
strata or layers of filtration material stacked or otherwise deposited one
against another to form a unitary pad-like composite" wherein "the
composite is either self-supporting and/or unitized encapsulated within a
porous outer envelope, sieve, or screen" (Spec. 3, 11. 6-10).
Thiele is directed to a multilayered deep bed filter material for
separating solids which is disclosed as providing for an improved degree of
filtration and economic efficiencies using graduated filtration in the filter
layers accommodating lower pressure drops over a long period of time while
yielding long service life (col. 1, 11. 39--43; col. 2, 11. 21-35). While Thiele
indicates that the filter material is useful, in particular, for air filtration,
Appellants' arguments do not substantiate that the ordinary worker would
have regarded Thiele' s filter material, which can comprise multiple layers of
fiber material, as non-analogous filter material that would have been
incapable of filtering a biopharmaceutical fluid and/or would not have been
reasonably pertinent to the problem of fashioning a deep gradient multilayer
filter packet that is capable of filtering such fluids.
In light of the above, the field of endeavor is not strictly limited to the
intended use set forth in the preamble of representative claim 1 as argued by
Appellants.
2 The Specification indicates that the disposable filtration units do not
require extensive fixed plumbing hardware, such as a stainless steel housing
that requires cleaning and validating, as used in conventional filtration
systems (Spec. 1, 1. 26-2, 1. 37). However, the disclosed disposable filter
unit does not preclude the use of fixed plumbing structures, such as a
stainless steel housing (Spec. 4, 1. 33-5, 1. 2).
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Moreover, even if we considered representative claim 1 to be directed
to a narrower field of endeavor that Thiele is not particularly directed to,
Appellants' arguments do not serve to demonstrate that Thiele does not
constitute analogous art that is reasonably pertinent to the problem or
problems at hand.
"If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability." KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007). "For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize
that it would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill." Id.
Furthermore, "'familiar items may have obvious uses beyond their primary
purposes."' In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1380 (Fed.
Cir. 2007) (quoting KSR, 550 U.S. at 420).
"A reference is reasonably pertinent if, even though it may be in a
different field from that of the inventor's endeavor, it is one which, because
of the matter with which it deals, logically would have commended itself to
an inventor's attention in considering his problem." In re Clay, 966 F.2d
656, 659 (Fed. Cir. 1992).
Nor is the problem to be addressed strictly limited to the inventor's
problem. After all, resolution of other problems facing an artisan can form
the basis for a modification of the prior art and, where appropriate, a
determination of obviousness. KSR, 550 U.S at 420 ("any need or problem
known in the field of endeavor at the time of invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed"); In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996) ("the
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motivation in the prior art to combine the references does not have to be
identical to that of the applicant to establish obviousness").
Here, Appellants' arguments fail to explain why the multilayer filter
material of Thiele would lack reasonable pertinence to fashioning the filter
unit of Gutman, particularly when employing more than one layer of filter
medium in each filter unit as taught by Gutman as an option (Gutman, col. 7,
11. 48--49).
As our reviewing court has indicated, labeling a reference as
analogous art "merely connotes that it is relevant to a consideration of
obviousness under§ 103 as 'prior art."' In re Sovish, 769 F.2d 738, 742
(Fed. Cir. 1985). Contrariwise, considering a reference as non-analogous art
is a determination that removes it as prior art to be considered; that is, it is
construed as being non-relevant evidence for consideration of the
obviousness question mandated by statute.
For reasons set forth above and in the Answer, we concur with the
Examiner that Appellants' arguments set forth in the Appeal Brief fail to
indicate that Thiele is not relevant to the obviousness question before us and
should be excluded from consideration.
Appellants' argument concerning a lack of motivation for one of
ordinary skill in the art to modify Gutman based on the additional teachings
of Thiele also lacks persuasive merit (Br. 20). In particular, Appellants
argue that the Examiner's rationale pertaining to low pressure drop and long
service life as a basis for employing the filter material of Thiele in Gutman
lacks merit because Gutman is directed to filters for biomedical uses and
process development whereas Thiele is principally concerned with air
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filtration and there is no reasonable expectation of success in employing the
filter medium of Thiele in Gutman (id.).
However, Gutman teaches or suggests that: (1) the filter medium can
be made with a variety of materials, including fiber materials corresponding
to those disclosed by Thiele, (2) more than one layer of filter medium can be
used in each filter unit, and (3) graded filtration may be employed (Gutman,
col. 3, 11. 51-55; col. 7, 11. 19-22, 48--49; Thiele, col. 1, 11. 39--44, col. 2, 11.
21-28, col. 3, 11. 7-37).
Consequently for reasons set forth above and by the Examiner in the
Answer, Appellants' argument fails to identify reversible error in the
Examiner's obviousness Rejections 1 and 2.
Rejections 3-5.
Appellants argue the rejected claims together as a group with respect
to Rejection 3, with the exception of claim 3. Accordingly, we select claim
1 as the representative claim on which we decide this appeal as to Rejection
3. Separate arguments are not presented with respect to Rejections 4 and 5.
Appellants rely on the non-analogous art arguments addressed above with
respect to Rejections 1 and 2 and without any further embellishment in
contesting any of Rejections 3 through 5 (Br. 21). For reasons discussed
above, these arguments are not persuasive of harmful error.
In addition, Appellants contend that the filter units of Pearl, the
primary reference utilized by the Examiner in Rejections 3-5, are for
tangential flow filtration and that there is no indication "that the Thiele
HEP A filters could be used in Pearl as tangential flow filters with any
reasonable expectation of success" and/or "that the highly porous HEPA
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filters of Thiele would be functional substitutes for the ... filter media
disclosed by Pearl" (Br. 22).
However and as determined by the Examiner, Pearl is not limited to
tangential filtration; rather, "Pearl also teaches dead-end filtration, where
fluid flows into the filter housing and is only able to flow through the filter
material before it is able to exit the housing, which is the same type of
filtration envisioned by Thiele" (Ans. 5; Final Rej. 7-8; Pearl, col. 6, 11. 36-
55; Fig. 7). Appellants do not dispute these findings of the Examiner.
Consequently, Appellants' argument concerning the tangential flow filter
embodiment of Thiele does not identify harmful error in the Examiner's
obviousness rejection.
As for Appellants' contention concerning the HEP A filters of Thiele
not being functional substitutes for the filter media of Pearl (Br. 22), the
Examiner has determined that Pearl teaches that the multi-layer porous filter
may be made from a variety of available synthetic types of materials,
including polypropylene, which is one of the synthetic fiber media materials
of the filter taught by Thiele (Ans. 5; Pearl, col. 4, 11. 6-25; Thiele, col. 4, 11.
8-28). As such, Appellants' argument that the media of Thiele is too
different from that of Pearl to be employed as a functional substitute in Pearl
lacks substantiation and fails to indicate harmful error in the Examiner's
proposed combination of Pearl and Thiele.
As observed by Appellants, dependent claim 3, which is subject to
Rejection 3, requires the deep gradient filter packet of claim 1 to include
"three layers of filtration material, the first two layers composed of cellulose
and diatomaceous earth and having a decreasing permeability as between the
first layer ([approximately] 1800 LMH/psi) and the second layer
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([approximately] 300 LMH/psi), and the third layer being a microporous
membrane of permeability ([approximately] 200 LMH/psi)" (Br. 22; claim
3). Appellants argue that the latter claim is separately patentable because
one of ordinary skill in the art would not have been motivated to combine
the stacked filter layers comprising cellulosics including kieselguhr as taught
by Strohm with a microporous membrane of Pearl. Furthermore, Appellants
contend that there is no suggestion to use the cellulosic layers of Strohm in
the arrangement of Pearl such that the stacked filter layers would have
permeability characteristics as required by claim 3.
Appellants' conclusory argument asserting a lack of motivation with
respect to dependent claim 3 does not specifically address the Examiner's
determination that there is ample motivation that would have led an
ordinarily skilled artisan to employ "the stratified arrangement of Strohm" as
the filter packet of Pearl because such an arrangement provides for staged
filtration and "ensures an especially high service life of the filter module," as
taught by Strohm (Final Rej. 8; Pearl, col. 4, 11. 26-36; Strohm, col. 4, 11. 15-
33). Nor do Appellants address the Examiner's additional reliance on the
teachings of Thiele with respect to the incentives for one of ordinary skill in
the art to employ a stratified multi-layer deep gradient filter packet in Pearl
in arguing for the separate patentability of dependent claim 3 (Final Rej. 8-
9; Thiele, col. 1, 11. 39--46; col. 2, 11. 1---6; col. 3, 11. 33-37, 53-56). As for
the permeability parameters required for the filter material layers as set forth
in dependent claim 3, Appellants' argument does not particularly explain
why the Examiner erred in determining that Strohm's suggestion of
employing multiple filter layers with the filter layers having graduated
degrees of separation capability (differing degrees of permeability) would
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have led one of ordinary skill in the art to workable permeability values for
the separate layers corresponding to those required by claim 3 (Final Rej. 9;
Strohm, col. 1, 1. 59---col. 2, 1. 5; col. 4, 11. 16-24). Thus, Appellants'
arguments do not indicate harmful error in the Examiner's obviousness
rejection of representative claim 1 and/or separately argued dependent claim
3 as regards Rejection 3. As noted above, no additional argument is
furnished for the Examiner's separate Rejections 4 and 5 pertaining to
certain claims and employing Pearl as the primary reference.
It follows that we shall sustain Rejections 3 through 5.
CONCLUSION/ORDER
The Examiner's decision to reject the appealed claims is affirmed.
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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