Ex Parte Krause et al

Patent Trial and Appeal Board

Feb 25, 2019

13120375 (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/120,375 04/27/2011 Bernd Krause
23643 7590 02/27/2019
Barnes & Thornburg LLP (IN)
11 S. Meridian Street
Indianapolis, IN 46204
UNITED ST A TES OF AMERICA
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.
52759-215754 9483
EXAMINER
MCNEIL, STEPHANIE AN
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BERND KRAUSE,
MARKUS NEUBAUER, and JOACHIM LOERCHER
Appeal2017-010792 1
Application 13/120,375
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN G. NEW, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to membranes
for use in cultivating cells. The Examiner entered a rejection based
alternatively on anticipation or obviousness, and also entered two additional
rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We affirm-in-part.
1 Appellants state that the real party in interest is Gambro Lundia AB.
Appeal Br. 3.
Appeal2017-010792
Application 13/120,375
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 1, 2, 4, 7, 8, 16, 21, 24, and 27, under 35 U.S.C. § I02(b)
as anticipated by, or alternatively under 35 U.S.C. § I03(a) as obvious over
Gohl2 (Ans. 2-6);
(2) Claims 1-5, 7, 8, 16, 17, 21, 24, and 27, under 35 U.S.C. § I03(a)
as unpatentable over Gohl and Bell3 (Ans. 6-8); and
(3) Claims 1--4, 7, 8, 16, 17, and 21-29, under 35 U.S.C. § I03(a) as
unpatentable over Gohl and Baurmeister4 (Ans. 8-9).
Claims 1, 7, and 8, the independent claims on appeal, are illustrative
and read as follows:
1. An irradiated membrane for the cultivation of
cells, the membrane comprising at least one of a polysulfone,
polyethersulfone and a polyarylethersulfone, and a
polyvinylpyrrolidone, which has been irradiated with at least
one of gamma-rays, beta-rays and an electron beam in a dose of
from 70 to 175 kGy in the presence of oxygen at a
concentration of 4 to 100 vol%.
7. A cell culturing device comprising an irradiated
membrane comprising at least one of a polysulfone,
polyethersulfone and a polyarylethersulfone, and a
polyvinylpyrrolidone, which has been irradiated with at least
one of gamma-rays, beta-rays and an electron beam in a dose of
from 12.5 to 175 kGy in the presence of oxygen at a
concentration of 4 to 100 vol%.
2 Bernd Krause et al., EP 1 875 957 Al (published Jan. 9, 2008) (hereinafter
"Gohl").
3 Carl-Martin Bell et al., US 5,543,465 (issued Aug. 6, 1996) (hereinafter
"Bell").
4 Ulrich Baurmeister et al., US 6,271,023 Bl (issued Aug. 7, 2001)
(hereinafter "Baurmeister").
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8. A device for the extracorporeal treatment of body
fluids, the device comprising cells and an irradiated membrane
including at least one of a lumen surf ace and an outer surface,
the membrane comprising at least one of a polysulfone,
polyethersulfone and a polyarylethersulfone, and a
polyvinylpyrrolidone, the cells forming a confluent layer on the
lumen surface or outer surface of the membrane, the membrane
having been irradiated with at least one of gamma-rays, beta-
rays and an electron beam in a dose of from 12.5 to 175 kGy in
the presence of oxygen at a concentration of 4 to 100 vol%.
Appeal Br. 38-39 (Claims App'x) (emphasis added to show claim language
at issue).
STANDARD OF REVIEW
As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
ANTICIPATION/OBVIOUSNESS-GOHL
The Examiner's Prima Facie Case
The Examiner rejected claims 1, 2, 4, 7, 8, 16, 21, 24, and 27 under
35 U.S.C. § 102(b) as anticipated by, or alternatively under 35 U.S.C.
§ 103(a) as obvious over Gohl. Ans. 2---6.
The Examiner determined that the alternative anticipation/obviousness
rejection was appropriate because the rejected claims are product-by-process
claims. Id. at 3-5 (citing MPEP §§ 706.02(m), 2112)).
The Examiner cited Gohl as disclosing: (1) a membrane for blood
filtration composed of polyethersulfone and polyvinylpyrrolidone as recited
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in the rejected claims, (2) that its membranes may be sterilized by gamma
radiation, as also recited in the claims, and (3) that cells are retained on its
membranes when blood filtering is performed. Id. at 3.
Based on those disclosures, the Examiner reasoned that Gohl
describes a membrane having all of the structural and functional features
required by the rejected claims, and that Gohl, therefore, anticipates the
rejected claims. Id. at 4---6.
Alternatively, the Examiner found, an ordinary artisan had motivation
for, and a reasonable expectation of success in, gamma-irradiating Gohl's
membrane and adding cells to Gohl's membrane, "because [Gohl] explicitly
suggests all of these modifications." Id. at 6. Therefore, the Examiner
concluded, "the invention as a whole would have been prima facie obvious
to a person of ordinary skill at the time the invention was made." Id.
Analysis-Claim 1 (and dependent claims)
It is well settled that, once the Examiner establishes that a product
recited in terms of its process of making is prima facie unpatentable due to
anticipation, Appellants bear the burden of proving "that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product." In re Thorpe, 777 F.2d 695, 698 (Fed. Cir. 1985)
( quoting In re Fitzgerald, 619 F .2d 67, 70 (CCP A 1980); In re Best, 562
F.2d 1252, 1255 (CCPA 1977)).
Having carefully considered all of the arguments and evidence
advanced by Appellants and the Examiner, Appellants persuade us that the
preponderance of the evidence does not support the Examiner's
determination that Gohl anticipates claim 1.
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In the present case, as the Examiner found, and as required by
Appellants' claim 1, Gohl discloses a membrane composed of
polythersulfone in combination with polyvinylpyrrolidone:
[ A ]ccording to the present invention there is provided a
process for manufacturing of an asymmetric hollow fibre
membrane, comprising the steps of extruding a polymer
solution through the outer ring slit of a hollow fibre spinning
nozzle, simultaneously extruding a centre fluid through the
inner bore of the hollow fibre spinning nozzle, into a
precipitation bath, whereby the polymer solution contains 10 to
26wt-% of polysulfone (PSU), polyethersulfone (PES) or
polyarylethersulfone (PAES), 8 to 15 wt-%
polyvinylpyrrolidone (PVP), 55 to 75 wt-% N-alkyl-2-
pyrrolidone (NAP) and 3 to 9 wt-% water ....
Gohl ,r 14.
As the Examiner found, and as required by Appellants' claim 1, Gohl
discloses using gamma radiation to sterilize its membrane. Id. ,r 17 ("The
mechanical stability of the membrane is excellent, and it is sterilizable by
steam, gamma radiation and/or ETO.")
As the Examiner contends, however, product-by-process claims are
evaluated as to the structure of the claimed product, as opposed to whether
the prior art necessarily describes preparing the allegedly anticipating
product by the same process recited in the product-by-process claim.
Thorpe, 777 F .2d at 697.
Thus, for a prior art product to anticipate a product recited in a
product-by-process claim, the prior art product must be identical to the
claimed product, including as to the structure of the claimed product. Id.
In other words, "if the process by which a product is made imparts structural
and functional differences distinguishing the claimed product from the prior
art, then those differences are relevant as evidence of no anticipation
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although they are not explicitly part of the claim." Purdue Pharma L.P. v.
Epic Pharma, LLC, 811 F.3d 1345, 1354 (Fed. Cir. 2016) (internal
quotations omitted).
In the present case, consistent with Appellants' contention that the
sterilization conditions recited in claim 1 impart a structural difference
between Gohl's membrane and the membrane recited in claim 1 (see Appeal
Br. 7), Appellants' Specification discloses that sterilizing membranes with
different gamma radiation dosages results in membranes that are structurally
and functionally different, as demonstrated by the membranes' distinct
capacities to support cell growth. See, e.g., Spec. 49.
Specifically, Appellants' Specification discloses that when a
membrane composed of polyethersulfone and polyvinylpyrrolidone
("VTK") was gamma-irradiated at a dosage of 25 kGy in air, 5 the resulting
membrane did not support consistent mesenchymal stem cell (MSC) growth
in all growth phases:
Id.
Air-covered VTK inserts irradiated with 25 kGy showed
controversial results comparing Experiments 1 and 2; in Figure
1, this membrane type performed comparable to TCPS [(tissue
culture polystyrene supports6)] in the first growth phase but
showed a strong decrease of MSC in the second growth phase,
whereas the membrane type behaved vice versa in Experiment
2.
In contrast, when a membrane composed of polyethersulfone and
polyvinylpyrrolidone was gamma-irradiated at a dosage of 75 kGy in air
5 Unmodified air contains about 20.95% molar content/volume. Spec. 28.
6 According to the Specification, "tissue culture polystyrene (TCPS) plates .
. . represent today's gold standard for cell expansion using culture flasks or
cell stacks." Spec. 30.
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(i.e., conditions encompassed by Appellants' claim 1 ), the resulting
membrane supported consistent mesenchymal stem cell growth in both the
first and second growth phases:
Id.
Air-covered VTK inserts irradiated with 75 kGy showed MSC
growth in both growth phases comparable or better than TCPS.
Coverage of VTK membranes with water or aqueous acrylic
acid solution with different concentrations during the gamma
irradiation procedure resulted in similar results as air-covered
VTK inserts irradiated with 75 kGy.
As seen above, although Gohl describes sterilizing its
polyethersulfone/polyvinylpyrrolidone membrane with precisely the type of
radiation required by Appellants' claim 1 (gamma radiation), Gohl does not
disclose applying a particular dosage of that radiation to the membrane. In
contrast, Appellants' claim 1 recites a specific radiation dosage range, from
70 to 175 kGy (Appeal Br. 38 (Claims App'x)), not expressly described in
Gohl.
As discussed above, moreover, Appellants' Specification provides
evidence that applying gamma radiation at a dosage within the range recited
in Appellants' claim 1 produces a membrane that is structurally and
functionally different from a membrane that has been sterilized by gamma
radiation applied at a dosage outside the range of claim 1. See Spec. 49.
Given the evidence of record that different gamma radiation dosages
yield membranes that are structurally and functionally different depending
on the radiation dosages, the Examiner does not persuade us that Gohl' s
generic disclosure of sterilizing its membranes with gamma radiation results
in a membrane that necessarily, that is inherently, has the same structure and
functional properties as the membrane recited in Appellants' claim 1. See
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Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009)
("The very essence of inherency is that one of ordinary skill in the art would
recognize that a reference unavoidably teaches the property in question."
(Emphasis added)).
In addition, as discussed in the Gohl Declaration 7 ( a declaration by
one of the inventors listed on the Gohl reference), a skilled artisan gamma-
irradiating the membranes according to the teachings in the Gohl reference
would have applied a radiation dosage in accordance with the European
Standard for sterilization of health care products, and would have applied a
sterilization dose of either 15 kGy or 25 kGy, rather than a dosage within the
range of 70 to 175 kGy recited in Appellants' claim 1. See Gohl Deel. ,r,r 9,
1 O; see id. at Exhibit A ( cited in Gohl Declaration as providing European
Standard for sterilization of a medical product).
Thus, in addition to the evidence, discussed above, that the Gohl' s
generic disclosure of sterilizing its membranes with gamma radiation would
not necessarily yield a membrane that is the same as the membrane recited in
Appellants' claim 1, Appellants have advanced evidence that a skilled
artisan following Gohl' s teachings would not necessarily have applied a
radiation dosage, recited in claim 1, that produces the claimed membrane.
We agree with Appellants, therefore, that the preponderance of the
evidence does not support the Examiner's determination that Gohl describes
a membrane having all of the features of the membrane recited in
Appellants' claim 1. Accordingly, we reverse the Examiner's rejection of
claim 1, and its dependent claims 2, 4, 16, and 21, as anticipated by Gohl.
7 Declaration under 37 C.F.R. § 1.132 of Hermann Gohl (signed Sept. 1,
2015) (hereinafter "Gohl Deel.").
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As noted above, the Examiner alternatively rejected claims 1, 2, 4, 16,
and 21 for obviousness over Gohl. Ans. 6. The Examiner, however,
identified no disclosure in Gohl suggesting the specific radiation dosage
recited in Appellants' claim 1, or the specific product resulting therefrom,
but instead relied on Gohl's generic disclosure of gamma-irradiating its
membranes which, as discussed above, does not mention any particular
radiation dosage.
Because the Examiner did not identify, nor do we discern, any
specific teachings in Gohl that would have taught or suggested, or resulted
in, a membrane having the structure and properties of the membrane recited
in Appellants' claim 1, we reverse the Examiner's rejection of claim 1, and
its dependent claims 2, 4, 16, and 21, for obviousness over Gohl.
Analysis-Claim 7 (and dependent claim)
Having carefully considered all of the arguments and evidence
advanced by Appellants and the Examiner, Appellants do not persuade us
that the preponderance of the evidence fails to support the Examiner's
determination that Gohl anticipates claim 7.
In contrast to the radiation dosage in claim 1 discussed above,
Appellants' claim 7 recites a device composed of a membrane that has been
irradiated at a much broader dosage, "of from 12.5 to 175 kGy." (Appeal
Br. 38 (Claims App'x) (claim 7)).
The gamma radiation dosage range recited in claim 7 encompasses the
dosages of 25 kGy or 15 kGy recommended by the European Standard for
sterilization of health care products, which the Gohl Declaration states are
the dosages that would have been applied by a skilled artisan following the
description of gamma-irradiation in the Gohl reference. See Gohl Deel. ,r,r
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9--10.
Appellants do not persuade us, therefore, that the gamma radiation
dosage recited in claim 7, used to prepare the irradiated device recited in
claim 7, structurally or functionally distinguishes the cell culture device
recited in claim 7 from the device described in the Gohl reference. As
discussed above, Gohl' s device has the same overall structure (membrane),
is undisputedly formed from the same combination of polymers, and is
sterilized by the same type of radiation as the device recited in Appellants'
claim 7. And as Appellants effectively concede, a skilled artisan would have
understood Gohl' s description of sterilizing its membrane as applying a
gamma radiation dosage encompassed by claim 7. See id.
We are also unpersuaded that Appellants have established that the
device recited in claim 7 is distinguishable from the device described in
Gohl based on the limitation requiring the sterilization to be performed in
the presence of oxygen at a concentration of 4 to 100 vol%. In addition to
the Gohl Declaration, Appellants cite the Saito reference8 as evidence that
Gohl's description of sterilizing its membranes would have been interpreted
as disclosing gamma sterilization in the absence of oxygen, as opposed to
the concentration of 4 to 100 vol%. See Appeal Br. 8-9 (incorporating by
reference arguments traversing rejection of claim 1 ).
While the cited portion of the Saito reference cautions against
excessively high radiation dosages, Appellants do not identify in the
reference any specific disclosures about excluding oxygen when performing
gamma-irradiation for sterilization purposes, nor does Saito disclose
8 HIGH-PERFORMANCEMEMBRANEDIALYZERS 116 (Akira Saito et al. eds.,
2011) (hereinafter "Saito").
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anything specific about the oxygen concentrations that would have been
used when following Gohl's description of sterilizing its membranes:
Another major reason for the suitability of polyarylsulfone
polymers for dialysis membranes is that they can be sterilized
with each of the three main sterilization modes used in the
medical devices industry: steam, y-rays and ethylene oxide
(ETO) .... However, it must be recognized that unlike steam
sterilization, both r-ray and ETO sterilization have been
associated with reactions that either may modify the dialyzer
materials. A high-energy input following irradiation may
destroy or degrade the polymer chain and give rise to
extractable oligomers. This alteration of PSu dialyzers by y-
rays may lead to enhanced cytotoxicity (fig. 4) and anaphylactic
reactions with ETO-sterilized dialyzers have been observed and
documented.
Saito 116 ( emphasis added).
As to the presence of oxygen when performing sterilization by
gamma-irradiation as described in the Gohl reference, the Gohl Declaration
states:
Generally, at the time of [sic] that Gohl was filed (July 2006),
irradiation of a membrane by a person of ordinary skill in the
art was done by avoiding the presence of oxygen, generally by
using inert gas atmosphere during irradiation or reducing it as
far as possible by using oxygen scavengers.
Gohl Deel. ,r 11. The Gohl Declaration, however, does not identify any
specific credible evidence supporting the assertions in the Declaration
regarding the general practices as to the presence of oxygen in gamma
sterilization procedures.
More importantly, Appellants do not identify any specific credible
evidence, in the Gohl Declaration or elsewhere in the record, supporting
their contentions that gamma irradiation as described in the Gohl reference
would have produced a membrane structurally or functionally different from
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the gamma-irradiated device recited in Appellants' claim 7. Specifically,
even assuming that a skilled artisan would have understood the Gohl
reference as describing gamma irradiation at reduced oxygen concentrations,
Appellants' claim 7 encompasses a significantly reduced oxygen
concentration (4 vol% (Appeal Br. 38)) as compared to the oxygen
concentration of unmodified air (20.95% (Spec. 28)). Also, Appellants do
not identify in the record any specific credible comparative evidence
demonstrating any difference between a device produced by a process
encompassed Appellants' claim 7, and the gamma-irradiated device that a
skilled artisan would have understood Gohl to describe, including the
generally understood low oxygen sterilization concentrations.
Although not cited in Appellants' arguments in relation to the
anticipation of claim 7, Appellants cite to the Yokota reference9 as evidence
that high oxygen concentrations would have been expected to degrade the
polymers in Gohl's membrane when the device was gamma-irradiated. See
Appeal Br. 19--20 ( citing Yokota ,r,r 62, 63).
Yokota, however, discloses only that the amount of oxygen in air,
which as discussed above is 20.95%, breaks down the polymers that form
the types of membranes taught in Gohl. See Yokota ,r 62 ("If the
sterilization by way of radiation exposure is carried in an atmospheric air,
excited oxygen radicals break the main chains of the polymers and
decompose them." (Emphasis added)).
In contrast, as noted above, Appellants' claim 7 encompasses
sterilization procedures in as low as 4% oxygen, which is significantly (over
9 Hideyuki Yokota et al., EP 1 795 254 Al (published June 13, 2007)
(hereinafter "Yokota").
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Application 13/120,375
five-fold) lower than the amount of oxygen in air. And as discussed above,
Appellants, do not identify, nor do we discern, any specific credible
evidence in Yokota or elsewhere in the record supporting the assertion that a
gamma-irradiated device sterilized according to the procedures encompassed
by claim 7 (including oxygen concentrations as low as 4%), differs in any
way from the gamma-irradiated device that a skilled artisan would have
understood Gohl to describe, including the generally understood low oxygen
sterilization concentrations.
In sum, for the reasons discussed, Appellants do not persuade us that
the preponderance of the evidence fails to support the Examiner's
determination that Gohl describes a device having all of the features required
by Appellants' claim 7. We, therefore, affirm the Examiner's rejection of
claim 7 as anticipated by Gohl. Because we affirm the Examiner's rejection
of claim 7 as anticipated by Gohl, we do not reach the Examiner's
alternative obviousness rejection of claim 7.
Appellants' claim 24 depends from claim 7, and recites "[ t ]he cell
culturing device of claim 7, wherein the device is configured for culturing
adherent cells." Appeal Br. 39 (Claims App'x). Appellants advance
extensive argument explaining why the plasmapheresis procedures described
in Gohl, which traps cells on the membrane, do not involve adherent cells.
Id. at 12-14.
We are not persuaded. Claim 24 only requires the claimed membrane
to be "configured for" culturing adherent cells. Id. at 39 (Claims App'x).
Appellants identify no structural element required by claim 24 that is
missing from the gamma-irradiated device that a skilled artisan would have
understood Gohl to describe, including the generally understood low oxygen
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sterilization concentrations.
That cells might or might not adhere to Gohl' s device when used for
plasmapheresis does not demonstrate that Gohl's device is incapable of
being used for culturing adherent cells. To the contrary, as discussed above
in relation to claim 7 from which claim 24 depends, Gohl's device, on this
record, has all of the structural and functional features required by the
rejected claims.
Because Appellants identify no structural element required by claim
24 that is missing from the gamma-irradiated device that a skilled artisan
would have understood Gohl to describe, including the generally understood
low oxygen sterilization concentrations, Appellants do not persuade us that
the Examiner erred in maintaining the rejection of claim 24 as anticipated by
Gohl. We, therefore, affirm the Examiner's rejection of claim 24 as
anticipated by Gohl. Because we affirm the Examiner's rejection of claim
24 as anticipated by Gohl, we do not reach the Examiner's alternative
obviousness rejection of claim 24.
Analysis-Claim 8 (and dependent claim)
Having carefully considered all of the arguments and evidence
advanced by Appellants and the Examiner, Appellants do not persuade us
that the preponderance of the evidence fails to support the Examiner's
determination that Gohl anticipates claim 8.
Claim 8 recites a device similar to the device recited in claim 7,
discussed above, the device including a confluent layer of cells on an inner
or outer lumen surface of a membrane composed of the same polymers
required by claims 1 and 7 discussed above, and irradiated under the same
conditions discussed above in relation to claim 7, including a radiation
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dosage of from 12.5 to 175 kGy in the presence of oxygen at a concentration
of 4 to 100 vol%. Appeal Br. 38-39 (Claims App'x).
As to claim 8 's requirement for a layer of confluent cells on the
membrane surface, the Examiner determined that "this limitation is
interpreted as referring to use of the claimed product, and not to a structural
property of the claimed product." Ans. 6. Appellants do not assert error in
the Examiner's claim interpretation, but instead reiterate their arguments that
Gohl's device is distinguishable from the claimed device, based on the
radiation dosage range and oxygen concentration range recited in claim 8.
See Appeal Br. 9-10.
As discussed above, however, the radiation dosage range of from 12.5
to 175 kGy recited in Appellants' claim 8 encompasses the dosages of 25
kGy or 15 kGy, which the Gohl Declaration states are the dosages that
would have been applied by a skilled artisan following the description of
gamma-irradiation in the Gohl reference. See Gohl Deel. ,r,r 9-10.
As also discussed above, Appellants do not identify in the record any
specific credible evidence, comparative or otherwise, demonstrating any
difference between a device produced by a process encompassed Appellants'
claim 8, and the gamma-irradiated device that a skilled artisan would have
understood Gohl to describe, including the generally understood low oxygen
sterilization concentrations. Appellants do not persuade us, therefore, that
the limitation as to the oxygen concentration during sterilization serves to
distinguish the device recited in claim 8 from the device that Gohl described
to a skilled artisan. We, therefore, affirm the Examiner's rejection of claim
8 as anticipated by Gohl.
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Claim 27 recites "[t]he device of claim 8, wherein the cells are
adherent cells." Appeal Br. 40 (Claims App'x).
Appellants' Specification states that, "[ a ]dherent cells are defined, in
the context of the present invention, as cells attaching to a substrate which
are to be maintained, expanded, differentiated, stored, etc." Spec. 18.
As the Examiner found, Gohl discloses that, when performing plasma
separation, blood cells are "retained by the membrane." Gohl ,r 53.
Thus, giving the term "adherent cells" its broadest reasonable
interpretation consistent with the Specification, Appellants' claim 27
encompasses the device described in Gohl when it is used to perform plasma
separation, because the cells retained on the membrane, at the very least, can
be stored, which is all that Appellants' definition of adherent cells requires.
Accordingly, even assuming that plasma separation procedures ultimately
require removal of cells from the membrane as Appellants contend, that fact
does not negate the fact that the Appellants' claim 27 encompasses the
device with the retained cells described by Gohl, under the proper claim
interpretation standard.
Because Appellants do not persuade us, therefore, that the Examiner
erred in maintaining the anticipation rejection of claim 27 over Gohl, we
affirm that rejection. Because we affirm the Examiner's rejection of claims
8 and 27 as anticipated by Gohl, we do not reach the Examiner's alternative
obviousness rejection of claims 8 and 27.
OBVIOUSNESS-- GOHL AND BELL
In rejecting claims 1-5, 7, 8, 16, 17, 21, 24, and 27 for obviousness
over Gohl and Bell, the Examiner relied on Gohl for the teachings discussed
above as to claims 1, 2, 4, 7, 8, 16, 21, 24, and 27, and cited Bell as evidence
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that it would have been obvious to include a polyamide in Gohl' s membrane
as recited in Appellants' claim 3, and also cited Bell as evidence that it
would have been obvious to cast Gohl's membrane in the form of a flat
sheet, as recited in Appellants' claim 5. See Ans. 6-8.
Claims 3 and 5 both depend from claim 1. Appeal Br. 38. Because
the Examiner does not identify any teaching in Bell that remedies Gohl' s
deficiencies discussed above in relation to claim 1, we reverse this rejection
as to claim 1, and its dependent claims 2-5, 16, 17, and 21.
As to claims 7 and 8, and their dependent claims 24 and 27, however,
Appellants only argue that Bell fails to remedy the deficiencies of Gohl as to
those claims, and also that the prior art teaches away from the claimed
invention. Appeal Br. 33-35. As discussed above, however, we are not
persuaded that Gohl fails to describe a device having all of the features
required by claims 7, 8, 24, and 27. In addition, Appellants fail to cite any
evidentiary support, or provide any explanation, for their contention that the
prior art teaches away from the claimed invention. We, therefore, affirm the
Examiner's rejection of claims 7, 8, 24, and 27 for obviousness over Gohl
and Bell.
OBVIOUSNESS-- GOHL AND BAURMEISTER
In rejecting claims 1--4, 7, 8, 16, 17, and 21-29 for obviousness over
Gohl and Baurmeister, the Examiner relied on Gohl for the teachings
discussed above as to claims 1, 2, 4, 7, 8, 16, 21, 24, and 27, and cited
Baurmeister as evidence that it would have been obvious to include a
polyamide in Gohl's membrane as recited in Appellants' claim 3, and also
cited Baurmeister as evidence that it would have been obvious to use Gohl' s
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membrane as a substrate for hepatocytes, as recited in Appellants' claims 22,
23, 25, 26, 28, and 29. See Ans. 8-9.
Claims 3, 22, and 23 all depend from claim 1. Appeal Br. 38, 39
(Claims App'x). Because the Examiner does not identify any teaching in
Baurmeister that remedies Gohl's deficiencies discussed above in relation to
claim 1, we reverse this rejection as to claim 1, and its dependent claims 2-
4, 16, 17, and 21-23.
As to claims 7 and 8, and their dependent claims 24--29, however,
Appellants only argue that Baurmeister fails to remedy the deficiencies of
Gohl as to those claims, and also that the prior art teaches away from the
claimed invention. Appeal Br. 36-37. As discussed above, however, we are
not persuaded that Gohl fails to describe a device having all of the features
required by claims 7, 8, 24, and 27. In addition, Appellants fail to cite any
evidentiary support, or provide any explanation, for their contention that the
prior art teaches away from the claimed invention. We, therefore, affirm the
Examiner's rejection of claims 7, 8, and 24--29 for obviousness over Gohl
and Baurmeister.
SUMMARY
We reverse the Examiner's rejection of claims 1, 2, 4, 16, and 21 as
anticipated Gohl.
We also reverse the Examiner's rejection of claims 1, 2, 4, 16, and 21
for obviousness over Gohl.
We affirm the Examiner's rejection of claims 7, 8, 24, and 27 as
anticipated by Gohl.
We do not reach the Examiner's alternative rejection of claims 7, 8,
24, and 27 for obviousness over Gohl.
18
Appeal2017-010792
Application 13/120,375
We reverse the Examiner's rejection of claims 1-5, 16, 17, and 21 for
obviousness over Gohl and Bell.
We affirm the Examiner's rejection of claims 7, 8, 24, and 27 for
obviousness over Gohl and Bell.
We reverse the Examiner's rejection of claims 1--4, 16, 17, and 21-23
for obviousness over Gohl and Baurmeister.
We affirm the Examiner's rejection of claims 7, 8, and 24--29 for
obviousness over Gohl and Baurmeister.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l ). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
19