Ex Parte Rangarajan et al

Patent Trial and Appeal Board

Feb 27, 2017

12970735 (P.T.A.B. Feb. 27, 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.
12/970,735 12/16/2010 Arvind Rangarajan 241262-1 6670
6147 7590 03/01/2017
GENERAL ELECTRIC COMPANY
GLOBAL RESEARCH
ONE RESEARCH CIRCLE
BLDG. K1-3A59
NISKAYUNA, NY 12309
EXAMINER
GALISTEO GONZALE, ANTONIO
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
03/01/2017 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):
haeckl@ge.com
gpo.mail@ge.com
Lori.e.rooney @ ge.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ARVIND RANGARAJAN, PRAMEELA SUSARLA, SCOTT
MICHAEL MILLER, REGINALD DONOVAN SMITH, SLAWOMIR
RUBINSZTAJN, and ANTON BELETSKII1
Appeal 2015-007778
Application 12/970,735
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to cell carriers and
methods for making and using the cell carriers. The Examiner entered final
rejections for anticipation, obviousness and non-statutory obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as General Electric Company.
Br. 2.
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Application 12/970,735
STATEMENT OF THE CASE
Background
Adherent cells have conventionally been grown on glass
surfaces or on polymer substrates. . . . While static culture
vessels . . . allow for some scale-up of adherent cell culture,
they become limiting at larger scales as they are labor-intensive,
subject to variability due to manual processing, and limited in
volumetric productivity (e.g. cell yield per volume of incubator
space).
Spec. 12.
Cell culture using bioreactors has long been practiced as the
preferred scale-up method for cell culture. . . . Typical
bioreactor vessels employ some means of agitation, such as
internal impellers, rocking or shaking mechanisms to suspend
the cells and allow mass transfer of nutrients, oxygen and
metabolic waste products. However, agitation can subject cells
to high degrees of flow-induced stress that can damage cells,
especially sensitive ones such as certain mammalian cell lines
and primary cells. . . . Therefore, carriers that protect cells from
agitation-induced damage are desired. Certain carrier designs
(e.g. macro porous beads, nonwoven fibrous mats) do offer
protection for cells; however, cell visualization and cell
recovery from such carriers is difficult.
Id. 13.
The Specification discloses “carriers for cell culture and
methods of making and using the carriers. One or more embodiments
of the carrier for cell culture comprise one or more indentations.” Id.
15.
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The Claims
Claims 1 and 3—18 are on appeal. Sole independent claim 1 illustrates
the appealed subject matter and reads as follows:
1. A carrier for growing adherent cells, comprising:
two or more outer surfaces; and
one or more structured indentations on two or more of
the outer surfaces, wherein the carrier has a length in a range
from about 0.2 mm to 25 mm, a width in a range from about 0.2
mm to 25 mm, and a height in a range from about 0.05 mm to
1.2 mm and each of the structured indentations has a major axis
in a range from about 0.1 mm to 0.5 mm, a minor axis in a
range from about 0.1 mm to 0.5 mm and a depth in a range
from about 0.025 mm to about 0.5 mm.
Br. 19 (Claims Appendix).
The Issues
The following rejections are on appeal:
Claims 1, 3—9, and 11—15 are rejected under 35 U.S.C. § 102(b) as
anticipated by Chan.2 Ans. 2.
Claims 1 and 3—15 are rejected under 35 U.S.C. § 103(a) as obvious
over Chan and Okano.3 Ans. 2.
Claims 1, 3—9, and 11—16 are rejected under 35 U.S.C. § 103(a) as
obvious over Chan and Wave Bioreactor.4 Ans. 2.
Claims 1, 3—9, 11—15, 17, and 18 are rejected under 35 U.S.C.
2 Chan et al., US 2009/0248145 Al, published Oct. 1, 2009 (“Chan”)
3 Okano et al., US 2003/0036196 Al, published Feb. 20, 2003 (“Okano”)
4 Wave Bioreactor® Product Catalog, Wave Europe 1—13 (2006) (“Wave
Bioreactor”)
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§ 103(a) as being unpatentable over Chan and Fryer.5 Ans. 2.
Claims 1, 3, 5—12, 17, and 18 are provisionally rejected on the ground
of obviousness-type double patenting as unpatentable over claims 1—17 of
copending Application No. 13/287,596. Ans. 3.
Anticipation
ISSUE
Does a preponderance of the evidence in this record support the
Examiner’s finding that Chan teaches Appellants’ claimed invention?
FINDINGS OF FACT (FF)
FF1. Chan discloses a “method of forming a three-dimensional
structure of unidirectionally aligned cells,” which includes “providing a
substrate with a microchannel. This microchannel is defined by at least a
pair of opposing lateral walls and a base. The microchannel has a distance
between the pair of opposing lateral walls, which is—in at least a portion of
the microchannel—within the micrometer range.” Chan 110. The cells are
allowed to adhere to the base of the microchannel and to proliferate. Id. 1
51.
FF2. Chan discloses that “[t]he microchannel may be located
anywhere on the substrate. Where a plurality of microchannels is provided
on the substrate, they may be located at any position relative to each other
and in any orientation with respect to each other.” Id. 141.
5 Fryer et al., WO 2009/105570 A2, published Aug. 27, 2009 (“Fryer”)
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FF3. Chan discloses that
[t]he microchannel may span (e.g. laterally, diagonally etc.) the
entire length/width of the substrate. Where the microchannel
does not span the entire length/width of the substrate it may
further be bounded by an additional pair of lateral walls, which
are typically in opposing relationship. The term “opposing
relationship” refers to the direction of matter that could flow
through the recess and/or the channel, such as an axis of the
channel.
Id. 143.
FF4. Chan discloses that “[t]he microchannels may have any desired
shape, including straight, bent or meandering (or otherwise winding) and
may include one or more bends, kinks or branches as long as the distance
between the two opposing lateral walls of at least one portion of the
microchannel is within the micrometer range.” Id. 144.
FF5. Chan discloses that “[i]n some embodiments the distance
between the two opposing lateral walls of at least a portion of the
microchannel or of the entire microchannel is selected to be in the range
from about 10 pm to about 800 pm.” Id. 145.
FF6. Chan discloses that “[t]he lateral walls of the microchannel may
be designed as surfaces of the substrate in which the microchannel may for
instance form a cavity or trench. . . . The lateral walls of the microchannel
may also form three-dimensional structures such as a cuboid or a cube.” Id.
146.
FF7. Chan discloses:
FIG. 6 shows scanning electron microscopy (SEM) images of a
substrate with microchannels used in an embodiment of the
invention in top view (FIG. 6A) and cross-sectional view (FIG.
6B). A common wall separating two channels is ~25 pm wide,
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a channel is about 160 pm wide. The depth of a channel is 60
pm.
Chan 174.
FF8. Chan discloses Figures 4A and 12 as two substrates for
performing the method of forming a three-dimensional structure of
unidirectionally aligned cells:
Id. at Figs. 4A, 12. The Examiner relies on both Figure 4 and Figure 12 as
disclosing two or more surfaces upon which one or more structured
indentations (microchannels) can reside. Final Act. 6. The Examiner relies
on Figure 4 as disclosing a microchannel that comprises the whole surface of
the substrate. Id.
FF9. Chan discloses the substrate
may be of any desired surface properties ... the surface
properties of the base of the microchannel, the entire channel or
the entire substrate that includes the microchannel(s) may be
altered where required. The respective surface, or a part
thereof, may for instance be altered by means of a treatment
carried out to alter characteristics of the solid surface. . . . Such
a treatment may include various means, such as mechanical,
thermal, electrical or chemical means.
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Chan 149. Chan provides multiple polymers that can be applied to the
substrate surface. Id.
FF10. Chan discloses:
Any cell may generally be selected to be seeded into the
microchannel. However, in the method of the invention cells
are selected that can align unidirectionally. Examples of
respective cells include, but are not limited to, smooth muscle
cells, skeletal muscle cells, endothelial cells, stem cells,
progenitor cells, myocytes, bone marrow cells, neurons,
pericytes and fibroblasts. Cells used in the method of the
present invention may be of any source.
Id. 1 50.
FF11. Okano discloses a method for culturing cells using a
temperature-responsive polymer. Okano, Abstract. Okano discloses:
the novel technique comprises, for example, first culturing
specified cells to a single layer (sheet) at 37° C., then detaching
only the cells on the temperature-responsive domain by
lowering the temperature (for example, to 25° C. or lower),
reraising the temperature to 37° C., and then seeding a different
kind of cells to make a domain of the different type of cells in
the specified cells which have been rendered a domain and are
stable.
Id. 131.
FF12. Wave Bioreactor discloses:
The Wave Bioreactor® is a disposable cell culture system. It
consists of three major components — 1) a rocker platform, 2) a
single-use cell culture Cellbag® and 3) an aeration/inflation
pump. The rocker platform imparts the wave motion to the
liquid inside the presterilized Cellbag and provides the
necessary oxygen transfer and mixing for cell growth and
productivity.
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inflated plastic bap
Wave Bioreactor 1.
FF13. Fryer discloses “methods and compositions for cell attachment
to, cultivation on and detachment from a solid substrate surface.” Fryer,
Abstract. Fryer discloses that the solid substrate surface can include
polystyrene. Id. at Table 6 (page 74).
FF14. Fryer discloses:
Surface modified plates were prepared by treating injection
molded items using a corona plasma treatment or a microwave
plasma treatment (Table 6). The polymer materials used in
injection molding were polystyrene .... The surface modified
plates were individually packed in plastic bags, then sterilized
by gamma irradiation (25 kGy), and finally stored at room
temperature until used in cell culture or surface characterization
experiments.
Id. 1216.
FF15. The Specification discloses:
[sjome embodiments of the kit of the invention for culturing
cells comprise a disposable housing or vessel pre-loaded with
one or more carriers. . . . The housing may be, for example, a
bag, a flask, a tank, a tube, a petridish or a bottle. The kit may
further comprise culture media suitable for cell growth.
Spec. 1 58.
ANALYSIS
The Examiner finds that Chan, which discloses a “method of forming
a three-dimensional structure of unidirectionally aligned cells,” teaches
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Appellants’ claimed invention. Final Act. 5—66; FF1. In this regard, the
Examiner finds that Chan and Appellants both disclose a “carrier for
growing adherent cells,” and that Chan’s carrier is comprised of one or more
microchannels on which “cells are allowed to adhere to the base of the
microchannel and to proliferate.” Id. at 6; FF1. The Examiner finds Chan
discloses “microchannels can be located anywhere on the substrate,”
and “in any orientation with respect to each other.” Id.', FF2. The Examiner
finds Chan discloses “[t]he lateral walls of the microchannel may be
designed as surfaces of the substrate in which the microchannel may . . .
form a cavity or trench.” Id.', FF6.
The Examiner relies on Chan Figures 4A and 12, shown below, which
depict two substrates for performing the method of forming a three-
dimensional structure of unidirectionally aligned cells.
The Examiner finds both Figures 4A and 12 depict cell carriers that
comprise “two or more surfaces . . . and one or more structured indentations
on two or more of the surfaces.” Id.', FF8.
The Examiner finds that because the microchannel of Chan
6 Final Action, mailed July 15, 2014.
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can comprise the whole surface of the substrate as shown in
[FJigure 4A, the width of the microchannel is up to ,8mm and
the lateral walls can form a cube, the width and length of the
microchannel can be up to 1 mm[], a minor axis in a range from
about 0.1 mm to 0.5 mm (the distance between the two
opposing lateral walls of at least a portion of the microchannel
or of the entire microchannel is selected to be in the range from
about 10 pm to about 500 pm . . . and a depth in a range from
about 0.025 to 0.5 mm (the depth of a channel is 60 pm . . .
Final Act. 8; FF7.
The Examiner concludes that
[bjecause the microchannels can be located anywhere on the
substrate and at any position relative to each other, [Chan’s
invention] encompasses microchannels on either side of the
substrate[], wherein the carrier has a length in a range from
about 0.2 mm to 25 mm, a width in a range from about 0.2 mm
to 25 mm.
Id. at 6; FF2. The Examiner further finds that the dimensions disclosed by
Chan permit the microchannels to have
a height in a range from about 0.05 mm to 1.2 mm . . . wherein
each of the structured indentations has a major axis in a range
from about 0.1 to 0.5 mm [and] ... a minor axis in a range from
about 0.1 mm to 0.5 mm . . . and a depth in a range from about
0.025 to 0.5 mm.
Id. at 7-8; FF7.
We agree with the Examiner’s factual findings and conclusion that
Chan teaches a carrier for growing adherent cells comprising two or more
surfaces and one or more structured indentations on two or more of the
surfaces, and wherein the carrier can have the dimensions of claim 1.
We agree with the Examiner (id. at 5—8) that Chan teaches methods
for culturing cells on a substrate inside of microchannels, and that the
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microchannels can take any orientation and configuration that is useful,
including comprising the entire surface of a two-surface substrate as shown
in Figure 4. FF8. Therefore, we agree with the Examiner that Chan teaches
“[a] carrier for growing adherent cells, comprising: two or more outer
surfaces” comprising “one or more structured indentations” on those
surfaces.
Moreover, we agree with the Examiner that Chan teaches that the
microchannels are defined by “at least a pair of opposing lateral walls . . .
within the micrometer range.” FF4. Chan further provides ranges for the
distance between the opposing walls of the microchannel and scanning
electron micrographs (SEM) with estimated measurements of the depicted
microchannels. FF7. Based on these micrographs and the disclosures, we
agree with the Examiner that Chan teaches growth of cells on microchannels
that comprise the claimed length, width, and depth and also within the
claimed minor and major axes. Final Act. 9—12; FF5, FF7. Therefore, we
agree that Chan anticipates claim 1.
Appellants argue the Examiner improperly extrapolated dimensions
from the drawings of Chan, and cites MPEP § 2125 and Hockerson-
Halberstadt, Inc. v. Avia Group Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir.
2000), for the proposition that “proportions of features in a drawing are not
evidence of actual proportions when drawings are not to scale and therefore
one cannot presume the dimensions from a drawing.” Br. 9—10.
This argument is not persuasive. This case is distinguishable from
MPEP § 2125 and Hockerson-Halberstadt because Chan is not “silent as to
dimensions.” Id. Rather, Chan provides specific size ranges for the
microchannels and SEMs from which actual measurements may be made,
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including photographs with a distance scale showing 50 pM, and based
upon which the Examiner discerned the size just as a road map reader may
determine the distance between two locations using the distance scale on the
road map. Ans. 4; FF7. Therefore, we agree with the Examiner that
extrapolation from the disclosed size ranges in Chan and measurements of
the images in the SEMs would have permitted the skilled artisan to
determine the size of the microchannels with specificity, and to understand
that they overlap with the range of claim 1. Appellants provide no evidence,
only attorney argument, to rebut the Examiner’s determinations.
Appellants next argue Chan does not disclose a carrier on two or more
outer surfaces. Br. 11. According to Appellants, “[e]ach of the drawings,
images, examples and embodiments of Chan describe the microchannels are
on one side of the substrate'1'’ and argue Chan does not “disclose or show
microchannels on both sides of the substrate” or disclose a reason or
advantage to doing so. Id. The Examiner responds, inter alia, that
since the microchannels may be located anywhere on the
substrate and at any position relative to each other with respect
to each other, without limitation on which side of the surface,
and at any position relative to each other, Chan et al. encompass
microchannels on opposite sides of the substrate. Furthermore,
Chan et al. teach that the lateral walls of the microchannel are
the structures that align the cells unidirectionally (abstract),
therefore, the position of the microchannels on the substrate
should not have any influence in the direction of cell growth
since it is the lateral walls of the microchannel that align the
cells unidirectionally.
Ans. 6.
The Examiner has the better position. Chan’s disclosure is clear that
microchannels can be located “anywhere on the substrate,” which would,
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absent evidence to the contrary, include both sides of a substrate. FF2.
Figures 4A and 12 also suggest growth on both sides of a substrate —
whether originally plated or folded following plating — is possible.
Appellants have not persuasively demonstrated otherwise.
Finally, Appellants argue “maintaining a three-dimensional structure
of unidirectionally aligned cells in a static culture of Chan would be
technically difficult, if not impossible, when seeded on both sides of the
Chan’s substrate.” Br. 11. The Examiner responds:
Chan et al. teach that the lateral walls of the microchannel are
the structures that align the cells unidirectionally (abstract),
therefore, the position of the microchannels on the substrate
should not have any influence in the direction of cell growth
since it is the lateral walls of the microchannel that align the
cells unidirectionally.
Ans. 6. The Examiner has the better position. Chan’s disclosure
contemplates unidirectional growth of cells on the lateral walls of
microchannels in that the cells grow in the same direction away from the
base of the lateral wall. Appellants’ arguments, without evidence, do not
persuade us that the Examiner erred in rejecting claim 1 for anticipation over
Chan. Accordingly, we affirm the Examiner’s rejection of independent
claim 1.
Claims 3—9 and 11—15 have not been argued separately and, therefore,
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
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Obviousness
1. Rejection over Chan and Okano
ISSUE
Does a preponderance of the evidence in this record support the
Examiner’s finding that Chan and Wave Bioreactor suggest the invention of
claims 1, 3—15, and 30?
ANALYSIS
The Examiner rejects claims 1, 3—15, and 30 over Chan and Okano.
Final Act. 15. Appellants argue only claims 1 and 10 on appeal. See Br.
12-14.
For the reasons given above (FF1—8), we find Chan anticipates and
also renders claim 1 obvious because it teaches every limitation of claim 1.
“[A] determination of anticipation, as well as obviousness, involves two
steps. First is construing the claim, . . . followed by, in the case of
anticipation or obviousness, a comparison of the construed claim to the prior
art.” Key Pharms. v. Hereon Labs. Corp., 161 F.3d 709, 714 (Fed. Cir.
1998). See also In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002)
(citations omitted) (“It is well settled that ‘anticipation is the epitome of
obviousness’”). The Examiner finds Chan “anticipates claims 1, 3-9, 11-15
and 30” for the reasons discussed in regards to anticipation. Final Act. 15.
Because Appellants do not separately argue them, claims 3—9, 11—15, and 30
fall with claim 1. In re Kaslow, 707 F.2d 1366, 1376 (Fed. Cir. 1983)
(Where “claims are not separately argued, they all stand or fall together.”);
37 C.F.R. § 41.37(c)(l)(iv). We consider only, therefore, whether claim 10
is rendered obvious over Chan and Okano.
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The Examiner finds Chan teaches “that the carrier can be coated with
different polymers to improve the growth of the cells.” Final Act. 15; FF9.
The Examiner finds Chan does not teach a coating “made of
thermoresponsive polymer, pH responsive polymer, or combinations
thereof.” Id.
The Examiner finds Okano teaches “a carrier coated with a
thermoresponsive polymer (bed material for cell culture having a surface
composed of domain A coated with a temperature responsive polymer” and
“that such coating allows detaching cells and reseeding the carrier by
changing the temperature.” Id.', FF11. The Examiner concludes it would
have been obvious to the skilled artisan to use “the carrier described by
[Chan] and coat it with a thermoresponsive polymer as described by Okano
et al. to obtain a coated carrier” in order to “detach cells and reseed the
carrier by changing the temperature.” Final Act. 15. We agree with the
Examiner and address arguments made by Appellants that were not
previously addressed above.
Appellants argue
merely disposing a temperature sensitive polymer-based bed
material of Okano to Chan’s substrate comprising microchannel
(at least a pair of parallel walls and a base) would not achieve
the thermoresponsive polymer, pH responsive polymer or both
coated carrier having specific dimension and indentations on
both side[s] of the carrier, as recited in claim 10 together with
independent claim 1.
Br. 13. According to Appellants,
Chan and Okano cannot be combined because the suggested
combination of Okano and Chan would require substantial
reconstruction and redesign of the elements shown in Chan’s
substrate as well as a change in the basic principle under which
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the Chan's substrate was designed to operate to form a three-
dimensional structure of unidirectionally aligned cells.
Id.
We are not persuaded. Chan teaches that its carrier, including the
microchannels, may be altered where required, including by chemical
treatment. FF9. Chan suggests addition of polymers to the substrate. Id.
Okano teaches a thermoresponsive polymer that can be used to influence
adherence of cells, and promote detachment and reattachment by alteration
of the temperature. FF11. Given these clear teachings, we are not
persuaded that the thermoresponsive polymer of Okano could not be added
to the substrate of Chan.
Appellants also argue that “Chan’s purported substrate is merely a
stationary, microfluidic device with microchannels for growing cells in one
direction, which is in stark contrast to the carrier of claim 1 that is designed
and sized for growing cells on a small, lightweight substrates that are
suspended in a liquid.” Br. 13—14. This argument is not persuasive as the
rejected claims do not claim growth of cells suspended in a liquid, and we
have addressed the issue of size of the substrates above.
Appellants provide insufficient evidence, and only attorney argument,
in support of their arguments. See In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997) (“[Attorney argument [is] not the kind of factual evidence that is
required to rebut a prima facie case of obviousness”). We affirm the
rejection of claim 10 in addition to claims 1, 3—9, 11—15, and 30, as
discussed above.
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2. Rejection over Chan and Wave Bioreactor
ISSUE
Does a preponderance of the evidence in this record support the
Examiner’s finding that Chan and Wave Bioreactor suggest the invention of
claims 1, 3—9, 11—16, and 30?
ANALYSIS
The Examiner rejects claims 1, 3—9, 11—16, and 30 over Chan and
Wave Bioreactor. Final Act. 16. Appellants argue only claims 1 and 16 on
appeal. See Br. 14—15.
For the reasons given above (FF1—8), we find Chan anticipates and
also renders claim 1 obvious because it teaches every limitation of claim 1.
Key Pharms., 161 F.3d at 714. The Examiner finds Chan “anticipates claims
1, 3-9, 11-15 and 30” for the reasons discussed in regards to anticipation.
Final Act. 16. Because Appellants do not separately argue them, claims 3—9,
11—15, and 30 fall with claim 1. Kaslow, 707 F.2d at 1376; 37 C.F.R.
§ 41.37(c)(l)(iv). Therefore, we consider only whether claim 16 is rendered
obvious over Chan and Wave Bioreactor.
The Examiner finds Chan teaches that “any cell may generally be
selected to be seeded into the microchannel.” Final Act. 16; FF10. The
Examiner finds Chan does not teach “the bioreactor wherein the bioreactor is
a stirred tank bioreactor or a reactor with rocking and rolling motion.” Id.
The Examiner finds Wave Bioreactor teaches “a bioreactor [for growing
cells] comprising a platform that holds the cell culture system and has a
rocking a rolling motion (page 1 first paragraph and figure). Wave
Bioreactor further describes that the rocking and rolling motion provides for
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oxygen transfer and mixing for cell growth.” Id. at 17; FF12. The Examiner
concludes it would have been obvious to the skilled artisan to use “the
bioreactor described by Chan et al. and place it on a rocker platform as
described by Wave Bioreactor to grow cells ... in order to provide for
oxygen transfer and mixing for cell growth.” Id. We agree with the
Examiner and address arguments made by Appellants that were not
previously addressed above.
Appellants argue the “Wave Bioreactor does not teach ... a carrier
having the structure of. . . dependent claim 16.” This argument is
unpersuasive as the Examiner’s rejection is based on the combined teachings
of Chan and Wave Bioreactor. See Final Act. 16. Nonobviousness cannot
be established by attacking the references individually when the rejection is
predicated upon a combination of prior art disclosures. In re Merck & Co.,
Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986); see also In re Keller, 642 F.2d
413, 426 (CCPA 1981) (finding “one cannot show non-obviousness by
attacking references individually where, as here, the rejections are based on
combinations of references” (citations omitted)). Therefore, whether Chan
or Wave Bioreactor individually fails to teach a cell carrier with the structure
of claim 16 is not dispositive. As stated by the Examiner, Wave Bioreactor
teaches a bioreactor comprising a platform for the cell culture system, and
which provides a rocking a rolling motion to provide oxygen transfer and
mixing for cell growth. Final Act. 16; FF12. The Examiner sufficiently
establishes that an ordinary artisan reading Chan and Wave Bioreactor
would have reasonably expected that the cell carrier of Chan could be placed
into the Cellbag of the Wave Bioreactor to permit cell growth to occur while
the bioreactor rocks on the platform. Id.
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Appellants also argue that because Chan teaches a “substrate is for
forming a three-dimensional structure of unidirectionally aligned cells''’ that
“a unidirectional movement of media through the microchannel is desired
for growing unidirectionally aligned cells.” Br. 15. Appellants argue that
“in a Wave Bioreactor, cells are subjected to a dynamic environment, such
as rolling or rocking motion, or under continuous stirring condition or under
wave motion” and that “cells which need to grow unidirectionally using
contact guidance cannot be grown in the conditions of a Wave Bioreactor, at
the very least because the dynamic environment of the Wave Bioreactor will
disrupt the unidirectional alignment of the cells and dislodge the cells from
the device.” Id. According to Appellants,
Chan’s static substrate and method for unidirectional cell
culture dramatically teaches away from the dynamic cell culture
of Wave Bioreactor . . . [and] it would not be obvious without a
great deal of improper hindsight to modify Chan or to combine
Chan with Wave Bioreactor to arrive at the carrier of claim[]
16.
Id. Appellants argue the ordinarily skilled artisan would not be motivated to
modify Chan’s substrate for use with the Wave Bioreactor and that the
combination “would render the cell culture system and method of Chan
inoperable, as well as the Wave Bioreactor.” Id.
These arguments are not persuasive.
Under the proper legal standard, a reference will teach away
when it suggests that the developments flowing from its
disclosures are unlikely to produce the objective of the
applicant’s invention. A statement that a particular
combination is not a preferred embodiment does not teach away
absent clear discouragement of that combination.
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Application 12/970,735
Syntex (U.S.A.) LLCv. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005)
(citations omitted).
Appellants have identified no teaching of Chan that suggests that cells
could not grow on its cell carrier if cultured in a “dynamic environment”
such as a Wave Bioreactor. Appellants’ own Specification identifies a
number of types of cell culture rockers that may be employed with its cell
carrier to promote cell growth, including “a reactor with rocking or rolling
motion, such as Wave Bioreactor™, a stirred tank bioreactor, a fluidized bed
bioreactor, fixed bed bioreactor, a roller bottle or airlift bioreactor.” Spec. 1
53. Appellants supply no evidence, only attorney argument, in support of
their argument that the cell carrier of Chan would not work on similar
bioreactors. Absent evidence, we are not persuaded. Geisler, 116 F.3d at
1470. We affirm the rejection of claim 16.
3. Rejection over Chan and Fryer
ISSUE
Does a preponderance of the evidence in this record support the
Examiner’s finding that Chan and Fryer suggest the invention of claims 1,
3-9, 11-15, 17, 18, and 30?
ANALYSIS
The Examiner rejects claims 1, 3—9, 11—15, 17, 18, and 30 over Chan
and Fryer. Final Act. 18—19. Appellants argue only claims 1,7, 17, and 18
on appeal. See Br. 16—17.
The Examiner finds Chan anticipates claims 1,3-9, 11-15 and 30 for
the reasons discussed in regards to anticipation. Final Act. 16. For the
reasons given above (FF1—8), we find Chan anticipates and also renders
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claim 1 obvious because it teaches every limitation of claim 1. Key
Pharms., 161 F.3d at 714.
Because Appellants do not separately argue them, claims 3—6, 8, 9,
11—15, and 30 fall with claim 1. Kaslow, 707 F.2d at 1376; 37 C.F.R.
§ 41.37(c)(l)(iv). Therefore, we consider only whether claims 7, 17, and 18
are rendered obvious over Chan and Fryer.
The Examiner finds Chan is directed to culturing stem cells. Final Act.
18; FF10. The Examiner finds Chan does not disclose “culturing cells
comprising a disposable housing preloaded with a carrier (claim 17),
wherein the disposable housing is a bag, a flask, a tube, a petridish or a
bottle (claim 18).” Id.
The Examiner finds Fryer
is directed to culturing stem cells and describes a kit comprising
a disposable housing pre-loaded with a carrier, wherein the
disposable housing is a bag (surface modified plates were
prepared by treating injection molded items using a corona
plasma treatment or a microwave plasma treatment.... The
polymer materials used in injection molding was polystyrene.
The surface modified plates were individually packed in plastic
bags, then sterilized by gamma irradiation and finally stored at
room temperature until used in cell culture or surface
characterization experiments.
Br. 18-19.
The Examiner concludes it would have been obvious to the skilled
artisan to use “the carrier described by Chan et al. and include the carrier in
a kit as described by Fryer et al. . . . in order to be able to sterilize and store
the carrier.” Id. at 19. We agree with the Examiner and address arguments
made by Appellants that were not previously addressed above.
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Appellants argue “Fryer does not disclose a carrier with one or more
structured indentation on both sides of the carrier, and therefore does not
supply the deficiency of Chan.” Br. 16. This argument is unpersuasive as
the Examiner’s rejection is based on the combined teachings of Chan and
Fryer. See Final Act. 18. Nonobviousness cannot be established by
attacking the references individually when the rejection is predicated upon a
combination of prior art disclosures. Merck & Co. Inc., 800 F.2d at 1097;
Keller, 642 F.2d at 426. Therefore, whether Chan or Fryer individually fails
to teach a cell carrier that is made of polystyrene, comprises a disposable
housing preloaded with a carrier, or a carrier wherein the disposable housing
is a bag, a flask, a tube, a petri dish or a bottle is not dispositive. As stated
by the Examiner, Fryer teaches a kit comprising a disposable housing that is
a bag pre-loaded with a carrier, and sterilized for later use. Final Act. 18—
19; FF13, FF14. The Examiner sufficiently establishes that an ordinary
artisan reading Chan and Fryer would have reasonably expected that the cell
carrier of Chan could be placed in the disposable bag of Fryer to create the
kit taught by the Specification. Id. at 19; FF15.
Appellants argue Fryer teaches “surface modified plates []
individually packed in plastic bags.” Br. 16. Appellants argue “the substrate
of Chan cannot be packed in the plastic bags of Fryer to provide a kit,
because Chan’s objective is to form a three dimensional structure of
unidirectionally aligned cells, which cannot be achieved by culturing cells in
plastic bags typically used in a dynamic bioreactor.” Id. According to
Appellants, culturing cells using Chan’s stationary microfluidic device in a
dynamic bioreactor such as that used by Fryer would be “functionally
inoperable” due to “extraordinary disadvantages” and that “the carriers of
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Fryer are packed in a disposable housing and are configured to be used in
suspension culture,” which is incompatible with Chan’s “stationary
microfluidic device.” Id. at 16—17. Appellants argue the ordinarily skilled
artisan would not be motivated to use Chan’s substrate with the plastic bags
of Fryer because the combination “would render the cell culture system and
method of Chan inoperable.” Id. at 17.
These arguments are not persuasive as Appellants supply no evidence,
only attorney argument, in support of their argument that the cell carrier of
Chan could not be packed in the plastic bags of Fryer to provide a kit. Where
this method is advocated in Appellants’ own Specification. FF15. Further,
Appellants raise no argument regarding why the cell carrier of Chan could
not be composed of polystyrene (claim 7) or comprise a disposable housing
preloaded with a carrier (claim 17). Absent evidence, we are not persuaded.
Geisler, 116F.3datl470. We affirm the rejection of claims 7, 17, and 18.
DOUBLE PATENTING
Claims 1, 3, 5—12, 17, and 18 are provisionally rejected on the ground
of obviousness-type double patenting as unpatentable over claims 1—17 of
copending Application No. 13/287,596. Ans. 3. Appellants “respectfully
request that the obviousness-type double patenting rejection be held in
abeyance until patentable subject matter has been identified.” Br. 17.
Accordingly, we summarily affirm the rejection. See Manual of Patent
Examining Procedure § 1205.02 (“If a ground of rejection stated by the
examiner is not addressed in the appellant’s brief, appellant has waived any
challenge to that ground of rejection and the Board may summarily sustain
it.”).
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Application 12/970,735
SUMMARY
We affirm the rejection of all claims.
TIME PERIOD FOR RESPONSE
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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