Ex Parte Miller et al

Patent Trial and Appeal Board

Jul 25, 2018

13287596 (P.T.A.B. Jul. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/287,596 11/02/2011
6147 7590 07/27/2018
GENERAL ELECTRIC COMPANY
GPO/GLOBAL RESEARCH
901 Main Avenue
3rd Floor
Norwalk, CT 06851
FIRST NAMED INVENTOR
Scott Michael Miller
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.
241262-2 1353
EXAMINER
GALISTEO GONZALE, ANTONIO
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
07/27/2018 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 SCOTT MICHAEL MILLER, YOSANG YOON,
SLA WOMIR RUBINSZTAJN, PETER KENNEDY DA VIS,
and PRAMEELA SUS ARLA 1
Appeal2017-004012
Application 13/287,596
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
RICHARD J. SMITH, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is General Electric Company.
App. Br. 2.
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Application 13/287 ,596
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1-17. Specifically, claims 1-9, 11,
and 12 stand rejected as unpatentable under 35 U.S.C. § I02(b) as being
anticipated by Chan et al. (US 2009/0248145 A 1, October 1, 2009)
("Chan").
Claims 1-12 stand rejected as unpatentable under 35 U.S.C. § I03(a)
as being obvious over the combination of Chan and Okano et al. (US
2003/0036196 Al, February 20, 2003) ("Okano").
Claims 1-9, 11-15, and 17 stand rejected as unpatentable under 35
U.S.C. § I03(a) as being obvious over the combination of Chan and Fryer et
al. (WO 2009/105570 A2, August 27, 2009) ("Fryer").
Claims 1-9, 11, 12, and 16 stand rejected as unpatentable under 35
U.S.C. § I03(a) as being obvious over the combination of Chan and S. Fujita
et al., Time-lapse Observation of Cell Alignment on Nanogrooved Patterns,
6 J. R. Soc. INTERFACE S269-77 (2009) ("Fujita").
Claims 1-17 also stand provisionally rejected as unpatentable under
the judicially-created doctrine of obviousness-type double patenting over
claims 1, 3, 5-12, 17, and 18 of Appellants' copending US Ser. No.
12/970,735 and Fujita.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
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NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a carrier for growing adherent
cells, comprising one or more surfaces and one or more relief features on
one or more of the surfaces. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A carrier for growing adherent cells, comprising:
one or more surfaces; and
one or more relief features on one or more of the surfaces,
wherein the carrier has a length at least about 0.2 mm, a width at
least about 0.2 mm, and a height in a range from about 0.012 mm
to 0.5 mm; and
wherein each of the relief features has a height in a range
from about 2 to 200 µm, and width in a range from about 20 to
200 µm.
App. Br. 17.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings
and conclusions establishing that Appellants' claims are prima facie
anticipated by, or obvious over, the combined cited prior art. We address
the arguments raised by Appellants below.
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A. Claims 1-9, 11, and 12 under 35 U.S.C. § I02(b) over Chan
Issue 1
Appellants argue these claims together. App. Br. 9. Appellants argue
that the Examiner erred because Chan does not anticipate the overall length
or width of the substrate, as recited in claim 1. App. Br. 10.
Analysis
Appellants dispute the Examiner's reliance upon, inter alia, Figure 4A
of Chan, of which the Examiner finds that: "since the microchannel can
comprise the whole surface of the substrate as shown in figure 4A, the width
of the microchannel is up to 0.8 mm, and the lateral walls can form a cube,
the width and length of the microchannel can be up to I mm." App. Br. 10
( quoting Final Act. 5). According to Appellants, as a matter of law,
proportions of features in a drawing are not evidence of actual proportions
when drawings are not to scale, and one cannot therefore presume the
dimensions from a drawing. Id. ( citing MPEP § 2125).
Appellants further question the Examiner's reliance upon Figure 6b of
Chan, arguing that Figure 6b a cross-sectional view of a part of the substrate
with its microchannel. App. Br. 10-11. Appellants contend that the overall
substrate dimension cannot be derived from this image, and that the overall
size of the substrate is not disclosed by Chan. Id. at 11.
We disagree with Appellants' contention that Chan fails to disclose
the overall length or width of the substrate. Claim 1 recites, in relevant part:
"wherein the carrier has a length at least about 0.2 mm, a width at least about
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0.2 mm." Figure 12 of Chan (which is also reproduced on the cover page of
Chan) is reproduced below:
Figure 12 of Chan illustrates the four most common folding
directions (I-IV) with respect to the microchannels (5), in which
cells (I) are grown.
Figure 12 of Chan expressly indicates that the intervals between the
walls of Chan's microchannels range from 10-160 µm and that the
maximum length of the carrier with four microchannels as illustrated is
therefore at least 640 µm (0.64 mm), which exceeds the minimum length of
"at least 0.2 mm," recited in claim 1.
Chan also teaches that: "[i]n typical embodiments the microchannel is
open along its length in that it defines a trench ( as opposed to a sub-surface
channel)," and that "[t]he microchannel may be of any length." Chan ,r,r 43,
45 (emphasis added). Further employing the scale indicated in Figure 12
discloses that, in this embodiment, the width of the carrier is at least 480 µm
(0.48 mm), which likewise exceeds the minimum of 0.2 mm recited in the
claim. We consequently agree with the Examiner that Chan discloses the
overall length or width of the substrate. While the Court states "arguments
based on drawings not explicitly made to scale in issued patents are
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unavailing," the drawings in Chan expressly disclose a scale and therefore
the facts here are distinguished from cases where no scale is provided. See
Nystrom v. Trex Co., Inc., 374 F.3d 1105, 1117 (Fed. Cir. 2004).
Issue 2
Appellant argues that the Examiner erred because Chan does not
disclose any relief features. App. Br. 11.
Analysis
Appellants argue that Chan discloses a substrate with a microchannel,
in which the microchannel is defined by at least a pair of opposing lateral
walls and a base. App. Br. 11 (citing Chan Abstr.). Appellants quote the
Examiner's finding that: "[t]he microchannel may possess a transverse
section of any desired profile, such as being a cuboid (paragraph [0044])."
Id. Appellants contend that the transverse section of Chan's microchannel
are not the "relief features" recited in claim 1. Id. Furthermore, Appellants
argue, the transverse section in Chan's microchannel clearly are not relief
features having a height in a range from about 2 to 200 µm, and width in a
range from about 20 to 200 µm. Appellants assert that no such dimensions
are disclosed by Chan, either in the detailed description of the invention, the
examples, or in any of the Figures. Id.
We are not persuaded by Appellants' argument. Appellants'
Specification discloses:
One or more relief features are designed on the carrier surface,
for example, as shown in FIG. 1. The relief feature comprises a
height and a width, wherein the height is in a range from about 2
to 200 µm, and width is in a range from about 20 to 200 µm. In
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one or more embodiments, a distance between every two relief
features is in a range of about 50 to 1000 µm.
Spec. ,r 31. Figure 1 of Appellants' Specification is reproduced below:
Figure 1 of Appellants' Specification depicts a cell carrier
comprising a plurality of relief features showing dimensions of
the carrier and each relief feature.
Figure 6b of Chan is reproduced below, for purposes of comparison:
Figure 6b2 of Chan depicts a cross-sectional view of the
substrate with microchannels used in an embodiment of the
invention.
We agree with the Examiner that the "walls" of the contiguous
microchannels, which extend upwards vertically from the "floor" of the
2 We note that Figure 6b of Chan shows a scale line that is 50 µm in length.
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microchannels in Chan's Figure 6b, correspond to the "relief features" of
claim 1, as depicted in Figure 1 of Appellants' Specification.
Claim 1 recites, in relevant part, that: "each of the relief features has a
height in a range from about 2 to 200 µm, and width in a range from about
20 to 200 µm." Chan expressly discloses that:
A wall that is shared by two contiguous microchannels [ as
depicted, e.g., in Figure 6b] may be of any width. As an
illustrative example, the width may be in the range, but not
limited thereto, of from about 1 µm to about 100 µm, such as e.g.
about 5 µm, about 10 µm, about 25 µm or about 50 µm.
Chan ,r 46. Chan further expressly discloses that, in Figure 6b: "A common
wall separating two channels is -25 µm wide .... The depth of a channel is
60 µm." Id. at ,r 74. We equate the "height" of the relief feature recited in
claim 1 with the "depth" of the microchannel in Chan and the "width" of the
relief feature of claim 1 to the "width" of the wall separating two
microchannels, and we consequently determine that Chan discloses a range
of height and width of the relief features recited in the claims. We
consequently affirm the Examiner's rejection of claims 1-9, 11, and 12 upon
this ground.
B. Claims 1-12 under 35 U.S.C. § 103(a) over Chan and Okano
Issue
Appellants argue that Chan and Okano do not teach or suggest the
recited limitations of the claims, and that the references cannot properly be
combined. App. Br. 12.
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Analysis
As we have explained supra, Chan discloses all of the limitations of
claims 1-9, 11, and 12. We therefore conclude, for the same reasons, that
these claims are obvious over Chan. See In re Kalm, 378 F.2d 959, 962
(C.C.P.A. 1967) (Anticipation is the epitome of obviousness).
Furthermore, to the extent that, upon review by our superior court the
claims are found to be not anticipated by Chan, we find that the range of the
dimensions of length and width provided in Figure 12 of Chan substantially
overlap those recited in claim 1. As such, we conclude that the claims are
obvious over the teachings of Chan. See In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003) ("In cases involving overlapping ranges, we and our
predecessor court have consistently held that even a slight overlap in range
establishes a prima facie case of obviousness").
That leaves claim 10 remaining on this ground of rejection. Claim 10
depends, ultimately, from claim 1 and recites: "The carrier of claim 8,
wherein the coating comprises a thermoresponsive polymer, pH responsive
polymer, or combination thereof." App. Br. 18.
The Examiner finds that Okano teaches a cell carrier coated with a
thermoresponsive polymer (bed material for cell culture having a surface
composed of domain A coated with a temperature-responsive polymer.
Final Act. 10 (citing Okano Abstr.). The Examiner also finds Okano teaches
that such a coating allows detaching cells and reseeding the carrier by
changing the temperature. Id. ( citing Okano ,r 31 ).
Appellants argue that Chan and Okano cannot be combined. App. Br.
12. According to Appellants, the suggested combination of Okano and Chan
would require substantial reconstruction and redesign of the elements shown
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in Chan's substrate as well as a change in the basic principle under which
Chan's substrate was designed to operate to form a three-dimensional
structure of unidirectionally aligned cells. Id. at 12-13. Furthermore,
Appellants argue, Chan's 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 small, lightweight substrates that are suspended in a liquid. Id. at
13.
We are not persuaded by Appellants' arguments. The Examiner
concluded that:
[I]t would have been obvious to a person of ordinary skill in the
art at the time of the invention to have the carrier described by
[Chan] and coat it with a thermoresponsive polymer as described
by Okano et al. to obtain a coated carrier. A person of ordinary
skill in the art would be motivated to do so in order to detach
cells and reseed the carrier by changing the temperature.
Final Act. 10. Appellants have adduced no evidence of record that the
teachings of Okano and Chan cannot be combined to provide a cell carrier
with a thermoresponsive coating. As such, we accord little probative weight
to their arguments. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997)
( Attorney arguments and conclusory statements that are unsupported by
factual evidence are entitled to little probative value).
Furthermore:
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of
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the references would have suggested to those of ordinary skill
in the art."
In re Keller, 642 F.2d 413,425 (C.C.P.A. 1981). In this instance, the
Examiner has stated a sufficiently rational motivation for a person of
ordinary skill in the art to combine the teachings of Chan and Okano, viz., to
be able to detach cells and reseed the carrier by changing the temperature.
Appellants have failed to adduce any evidence of record to overcome the
Examiner's findings and primafacie conclusion of obviousness. We
consequently affirm the Examiner's rejection of the claims.
C. Claims 1-9, 11-15, and 17 under 35 U.S.C. § 103(a) over Chan and
Issue
Appellants argue that the Examiner erred because Fryer does not cure
the alleged deficiencies of Chan. App. Br. 13.
Analysis
As we have explained supra, claims 1-9, 11, and 12 are anticipated
by, and obvious over, the teachings of Chan. Claims 13-15 and 17 thus
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remain to be considered on this ground. Claims 14 and 15 depend from
claim 1 and are representative, and recite:
14. A kit for culturing cells, comprising a disposable housing
pre-loaded with the carrier of claim 1.
15. The kit of claim 14, wherein the disposable housing is a
bag, a flask, a tube, a petri dish, or a bottle.
App. Br. 18.
The Examiner finds Fryer teaches a kit for culturing stem cells
comprising a disposable housing pre-loaded with a cell carrier. Final Act.
12. The Examiner finds Fryer teaches that the disposable housing is a bag,
and that the surface modified plates were prepared by treating injection-
molded items using a corona plasma treatment or a microwave plasma
treatment. Id. ( citing Fryer Table 6). The Examiner finds that Chan teaches
that the polymer materials used in injection molding is polystyrene and that
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. Id. ( citing Fryer
Appellants argue that a person of ordinary skill in the art would not
have had a reason to combine the substrate of Chan with the plastic bags of
Fryer because such a combination would render the cell culture system and
method of Chan inoperable. App. Br. 14. Specifically, Appellants point out
that Chan teaches that: "contact guidance cues are provided by the pair of
opposing lateral walls of the microchannel, such that the cells aligned
unidirectionally." Id. (quoting Chan Abstr.). Appellants therefore argue that
Chan suggests that a unidirectional movement of media through the
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microchannel is desired for growing unidirectionally-aligned cells, and that
the disadvantage of culturing cells for Chan using dynamic bioreactor is that
the unidirectional motion of media would not be maintained and probability
of disruption of the three dimensional structure of unidirectionally-aligned
cells in dynamic bioreactor. Id. Furthermore, argue Appellants, the carriers
which are packed in disposable housing are configured to be used under
suspension culture, which is not possible for Chan, as Chan's unidirectional
cell alignment may not be maintained in suspension culture. Id.
We are not persuaded by Appellants' arguments. Fryer teaches: "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." Fryer ,r 216. Fryer also teaches that: "Surface modified
plates 1--4 and 13 were individually packed in plastic bags, sterilized, and
stored at room temperature throughout the test period." Id. at ,r 220; see also
,r 255. The Examiner thus relies upon Fryer as teaching simply the use of
bags as a means of sterile storage of cell culture plates until ready for use. It
is not necessary, in this instance, for the all of the teachings of Fryer to be
physically combinable with those of Chan beyond this limitation. See
Keller, 642 F.2d at 425.
We therefore agree with the Examiner that a person of ordinary skill
would be motivated to combine the teachings of Fryer and Chan such that
the prepared plates of Chan could be stored in a sterile manner prior to their
use, as taught by Fryer. See Final Act. 12. We consequently affirm the
Examiner's rejection of claims 1-9, 11-15, and 17 upon this ground
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D. Claims 1-9, 11, 12, and 16 under 35 U.S.C. § 103(a) over Chan and
Issue
Appellants argue the Examiner erred because neither Chan nor Fujita
teach or suggest the carrier of claims 1-9, 11, 12, or of claim 16, in which
the cells are human mesenchymal stromal cells (hMSC), Chinese hamster
ovary (CHO) cells, Madin-Darby canine kidney (MDCK) cells, or Vero
cells. App. Br. 15.
Analysis
As we have explained supra, claims 1-9, 11, and 12 are anticipated
by, and obvious over, the teachings of Chan. Claim 16 alone, therefore,
remains to be scrutinized upon this ground. Claim 16 recites: "The carrier
of claim 1, wherein the cells are human mesenchymal stromal cells (hMSC),
Chinese hamster ovary (CHO) cells, Madin-Darby canine kidney (MDCK)
cells, or Vero cells." App. Br. 18.
Appellants assert that Fujita teaches seeding MSCs on polycarbonate
plates that were 20 mm in diameter and 3 mm thick, which, Appellants
argue, teaches away from the carrier with relief features recited in claim 1.
App. Br. 15. Furthermore, Appellants contend, Fujita neither teaches nor
suggests a relief feature on the carrier, nor the specific dimensions of the
carrier and the relief features. Id. Appellants contend that it would not be
obvious without impermissibly applying hindsight reasoning to modify
Chan, or to combine Chan with Fujita, to arrive at the carrier of claims 16.
Id.
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We are not persuaded. We have already explained, in Section A
supra, why we find that Chan teaches the dimensions and the relief features
recited in claim 1. Chan is directed to the culture of cells on its carriers, and
expressly teaches:
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.
Chan ,r 50 ( emphasis added). Fujita teaches the culturing of aligned, human
bone marrow-derived mesenchymal stroma cells ("MSCs") on nanogrooved
patterns. Fujita s269, s270. We agree with the Examiner that a person of
ordinary skill would be motivated, with a reasonable expectation of success,
to combine the teachings of Chan and Fujita. Chan teaches that stem cells
that can align unidirectionally are suitable for its methods, and Fujita teaches
that human mesenchymal stem cells, as recited in Appellants' claim 16, are
capable of self-aligning in culture.
Appellants suggest that Fujita teaches away from Appellants' claimed
carrier, because Fujita employs a different cell carrier surface. See App. Br.
15. We disagree. First, the Examiner finds, and we agree (as we have
explained in Section A), that Chan teaches the claimed carrier; the Examiner
relies upon Fujita as teaching the culture of human mesenchymal stem cells,
and the teachings of Chan expressly invite the culture of such stem cells.
See Chan ,r 50. "[O]ne cannot show non-obviousness by attacking
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references individually where ... the rejections are based on combinations of
references." Keller, 642 F.2d at 426.
Second, a reference teaches away when "a person of ordinary skill,
upon reading the reference, would be discouraged from following the path
set out in the reference, or would be led in a direction divergent from the
path that was taken by the applicant." In re Gurley, 27 F.3d 551, 553
(Fed.Cir.1994). Appellants adduce no evidence of record, nor can we
discern any, that would discourage or divert an artisan of ordinary skill from
culturing human MSCs in the carrier of Chan, as expressly contemplated by
Chan. We do not agree, therefore, that Fujita teaches away from Appellants'
claimed invention.
Finally, with respect to Appellants' allegation that the Examiner
impermissibly employed hindsight reasoning to arrive at the conclusion that
the claims are obvious over the cited prior art:
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). Appellants have
pointed to no limitation of the claims on appeal that could only have been
derived only from Appellants' Specification and not from the combined
teachings of the cited prior art. We consequently affirm the Examiner's
rejection of the claims 1-9, 11, 12, and 16 upon this ground.
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D. Claims 1-17 under the doctrine of obviousness-type double patenting
Appellants request that the obviousness-type double patenting
rejection be held in abeyance until patentable subject matter has been
identified. App. Br. 16.
However, because we affirm the Examiner's rejection of claims 1-17
under 35 U.S.C. §§ 102(b) and/or 103(a), and because Appellants do not
argue the merits of the Examiner's rejection upon this ground, we summarily
affirm the Examiner's rejection of claims 1-17 under the nonstatutory
doctrine of obviousness-type double patenting.
DECISION
The Examiner's rejection of claims 1-9, 11, and 12 under 35 U.S.C.
§ 102(b) is affirmed.
The Examiner's rejection of claims 1-17 under 35 U.S.C.
§ 103(a) is affirmed.
The Examiner's rejection of claims 1-17 under the nonstatutory
doctrine of obviousness-type double patenting 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)(l )(iv).
AFFIRMED
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