Ex Parte Rapp

Patent Trial and Appeal Board

Jul 5, 2017

13074936 (P.T.A.B. Jul. 5, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/074,936 03/29/2011 Edward J. Rapp FLO-004 1722
140000 7590
Flocel Inc.
4415 Euclid Ave., Suite 421
Cleveland, OH 44103
07/05/2017 EXAMINER
MARCHESCHI, MICHAEL A
ART UNIT PAPER NUMBER
1799
MAIL DATE DELIVERY MODE
07/05/2017 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDWARD J. RAPP
Appeal 2015-004302
Application 13/074,9361
Technology Center 1700
Before DONALD E. ADAMS, ROBERT A. POLLOCK, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal2 under 35 U.S.C. § 134(a) involves claims 29—31, 33,
and 34 (Adv. Act.3 1; see generally Ans.4 2).
1 Appellant identifies the real party in interest as “Flocel Inc.” (App. Br. 2.)
2 This Appeal is related to Appeal 2012-006187 (Application 11/514,427),
Decision affirming the rejection of record entered December 12, 2014 and
2013-001 111 (Application 11/514,620), Decision affirming the rejections of
record entered September 4, 2012 (see In re Rapp, 528 Fed. Appx. 995
(Mem) (Fed. Cir. 2013)).
3 Examiner’s December 2, 2014 Advisory Action.
4 Examiner’s Answer entered December 31, 2014.
Appeal 2015-004302
Application 13/074,936
Examiner entered rejections under 35 U.S.C. § 103(a).5 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellant’s disclosure “relates to joining two or more cartridges each
containing different cell or tissue cultures in fluid connection” (Spec. 1).
Examiner entered Appellant’s After-Final Claim amendments (Adv. Act. 1).
Therefore, we review this record in the context of Appellant’s claims made
of record in Appellant’s Amendment After Final.6 Claims 29, 31, and 33 are
representative and reproduced below:
29. A cartridge system for testing an effect of chemicals and/or
agents on two types of cells and/or tissues comprising:
a system comprising at least two cartridges, human organ cells
or tissues from two types of human organs, connective tubing
and a solution containing a chemical or an agent;
each of the at least two cartridges each comprising at least one
hollow and porous fiber running through a portion or entire
length of the cartridge and an extracapillary space about the
hollow porous fiber, the at least one hollow and porous fiber of
each of the at least two cartridges being used to transfer the
solution comprising the chemical or the agent to be tested, are
fluidly connected with each other with the connective tubing, and
5 Examiner states that “[t]he ground(s) of rejection set forth in the Office
[Ajction dated 12/31/2013 from which the appeal is taken have been
modified by the Advisory [Ajction dated 12/02/2014” (Ans. 2; cf.
Appellant’s May 30, 2014 Appeal Brief (hereinafter App. Br.) 2). Examiner
found claims 21—28 and 35—40 allowable (Adv. Act. 1). Examiner’s
objection to Appellant’s claim 32 is a petitionable, rather than appealable
issue (see Adv. Act. 1). Therefore, Examiner’s objection of claim 32 was
not included in our deliberations.
6 Filed March 31, 2014.
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Application 13/074,936
each of a first and a second cartridge comprising different cells
or tissue of the different human organ in the extracapillary space;
wherein the chemical or agent is from the group consisting of
drugs, chemicals, poisons, herbs, proteins, vitamins and minerals
and the solution comprising the chemical or agent is run through
the hollow and porous fiber of the first cartridge; and the
chemical and/or agent that passes through the pores of the at least
one hollow and porous fiber and the cell or tissue in the
extracapillary space of the first cartridge is then run through the
pores of the at least one hollow and porous fiber and through the
connective tubing into the cell or tissue of the second cartridge
to determine the effect of the chemical or agent on the two
different types of cells or tissues in sequence.
(Amendment After Final 4—5 (emphasis removed).)
31. The system of claim 29, wherein the system is configured to
test at least two chemicals and/or agents simultaneously.
(Id. at 5.)
33. The system of claim 29, wherein the at least one hollow and
porous fiber running through a portion or entire length of each
cartridge have an inner diameter about 300 micrometers ([p]m).
(Id.)
The claims stand rejected as follows:
Claims 29-31 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Shuler7 and Hamzeh.8
Claims 33 and 34 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Shuler, Hamzeh, and Tolbert.9
7 Shuler et al., US 5,612,188, issued Mar. 18, 1997.
8Hamzeh et al., US 6,287,848 Bl, issued Sept. 11, 2001.
9 Tolbert et al., US 4,537,860, issued Aug. 27, 1985.
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Application 13/074,936
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Shuler “relates to an in vitro system for physiological and metabolic
evaluation of substances for use in living beings” (Shuler, Abstract; see
Final Act.10 11—12; Adv. Act. 2).
FF 2. Shuler’s
system includes one or more cell culture chambers, each
containing cells in a culture medium and a gas-liquid exchange
device for contacting the culture medium with oxygen-
containing gas so that the culture medium absorbs that gas and
desorbs carbon dioxide-containing gas. The conduit system
conducts culture medium between the gas-liquid exchange
device and the cell culture chambers. A circulation mechanism
is used to circulate culture medium through the conduit system,
the cell culture chambers, and the gas-liquid exchange device. In
use, the substance to be evaluated is added to the culture medium
of the system and circulated through the system. The cells in
each of the cell culture chambers are then evaluated for effects
resulting from the presence of the substance.
(Shuler, Abstract; see Final Act. 11—12; Adv. Act. 2.)
10 Examiner’s December 31, 2013 Final Office Action.
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FF 3. Shuler’s Figure 1 is reproduced below:
FIG. 1
Shuler’s “FIG. 1 is a block diagram of a system in accordance with the
present/invention” (Shuler 4:10-11; see generally Final Act. 11—12; Adv.
Act. 2).
FF 4. Examiner finds:
Shuler discloses a cartridge system (called multi-compartmental
cell culture system). . . comprising a system comprising at least
two cartridges ((called cell culture chamber/compartment (2),
(8), (10), (12),[](14), (16) and (18) in [Shuler’s] [F]ig. 1 . . .
human organ cells/tissues from two types of human organs (for
example in [F]ig. 1 chamber (2) is used for lung cells, chamber
(8) for liver cells and chamber (16) used for gut cells . . . ,
connective tubing (conduits of the conduit system that medium
between the cell culture chambers .. .) and a solution containing
a chemical or an agent...; each of the at least two cartridges are
fluidly connected with each other and each having different cell
or tissue of a different human organ . . . ; wherein the solution
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Application 13/074,936
comprising the chemical or agent is run through the cartridge
system to determine the effect of the chemical or agent on the
two different types of cells or tissues in sequence . . . and
evaluating the cells in each of said chambers for physiological
and metabolic changes resulting from the presence of the
substances ....
(Final Act. 11—12 (citing Shuler, Abstract, 2:26—55, 3:20—60, 4:1—8, 5:25—
65, 6:10-40 and 60-65, 7:43—61, 10:19-37 (“Each chamber contains a cell
type of the organ it is intended to simulate”), 12:56 — 13:8, Fig. 1, Fig. 3,
Fig. 4, Fig. 16, and Shuler’s claims 1, 11, 22, and 26); see Adv. Act. 2
(citing Shuler 2:39-56 (the chemical or agent may be a “pharmaceutical
drug”)).)
FF 5. Examiner finds that Shuler discloses a “system . . . configured to test
at least two chemicals and/or agents simultaneously” (Final Act. 15 (citing
Shuler 3:20-30)).
FF 6. Examiner finds that Shuler discloses a system comprising “a
chamber configured as a hollow fiber unit,” wherein “the use of a hollow
fiber unit substantially reduces the culture medium volume necessary to
operate the system” (Final Act. 12 (citing Shuler 32:65 — 33:5 and 33:37-40;
Adv. Act. 2)).
FF 7. Examiner finds that Shuler discloses the use of “known (i.e. ready­
made) cell culture compartments/chambers to be simply plugged into
[Shuler’s] system” (Final Act. 12—13, citing Shuler 7:61—65; Adv. Act. 2).
FF 8. Hamzeh discloses “a monitoring system, more particularly, a dosage
modeling system which delivers therapeutic agents (e.g., drugs) to cultured
cells in a bioreactor to simulate human pharmacokinetics and
pharmacodynamics” (Hamzeh 1:13—17; see Final Act. 13; Adv. Act. 2).
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FF 9. Hamzeh discloses that “the bioreactor provides for physically
retaining . . . cells, e.g., trapping or immobilizing them in or on the outside
of hollow fibers, in ceramic matrixes or between planar membranes; or
microencapsulating or immobilizing them in beads” (Hamzeh 10:55—61; see
Final Act. 13).
FF 10. Examiner finds that Hamzeh discloses a “bioreactor [that] includes a
cartridge suitable for culturing cells, wherein said cartridges comprising
multiple hollow porous cellulose/polypropylene fibers/capillaries which
divide the cartridge into two compartments, an intra-capillary compartment
and an extra capillary compartment, wherein the intra-capillary compartment
and the extra capillary compartment are connected by micropores” (Final
Act. 13 (citing Hamzeh 1:13—17, 2:55 — 3:7, 3:45—53, 3: 62 — 4:6, 4:66 —
5:10,5:21-23,6:55-57, 10:21-31, 10:53 - 11:17, 21:35-53, and Figs. 1-
5A); Adv. Act. 2—3).
FF 11. Hamzeh’s “bioreactor . . . includes a cartridge suitable for culturing
. . . cells,” wherein “[t]he cartridge, which is preferably a fiber cartridge, is
typically formed of multiple cellulose or polypropylene capillaries. The
capillaries divide the cartridge into two compartments, an intra-capillary
compartment and an extra-capillary compartment” (Hamzeh 10:62 — 11:3).
FF 12. Hamzeh discloses that the “intra-capillary compartment [of the
bioreactor] is used to perfuse the cells,” wherein the
extra-capillary compartment [of the bioreactor] plates the cells
within the extra-cellular space, and ... is used during
supplemental perfusion. The intra-capillary compartment and
extra-capillary compartment are connected by micropores that
allow selected molecules or materials to move between the two
compartments. Molecules which have the proper sizing can
move between compartments in this way. [The] intra-capillary
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compartment . . . includes capillary walls . . . which are
perforated... to allow the simulated body fluid to enter the extra­
capillary compartment....
(Hamzeh 11:4—17; see Final Act. 13; Adv. Act. 2—3.)
FF 13. Examiner finds that Hamzeh’s “bioreactor simulates a human or
animal tissue system” (Adv. Act. 2 (citing Hamzeh 7:41—56 and 21:35—53)).
FF 14. Examiner finds that the combination of Shuler and Hamzeh fails to
“disclose that the at least one hollow and porous fiber running through a
portion or the entire length of each cartridge have an inner diameter about
300 micrometers” and relies on Tolbert to make up for this deficiency in the
combination of Shuler and Hamzeh (Final Act. 16 (citing Tolbert, Abstract,
3:19-65, and 8:43^17)).
ANALYSIS
The combination of Shuler and Hamzeh'.
Based on the combination of Shuler and Hamzeh, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious
to replace the two or more cartridges (i.e. culture
chambers/unit/compartments) in the device of Shuler with the
hollow fiber[] units as disclosed by Hamzeh, since the use of
hollow fiber units allows the in vitro system to simulate/mimic
the vascular network of the living tissue (i.e. the hollow fiber
units allows an in vitro system to mimic/simulate the in vivo
capillary system of the tissue) and Shuler . . . discloses that the
use of hollow fiber units substantially reduces the culture
medium volume necessary to operate the system.
(Final Act. 13—14; see also Adv. Act. 2—3.)
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Claim 29\
The combination of Shuler and Hamzeh suggests a bioreactor that
comprises hollow fiber cartridges, having an extra-capillary compartment for
plating cells and an intra-capillary compartment with perforated, i.e. porous,
capillary walls to allow fluid to pass through the intra-capillary walls to cells
in the extra-capillary compartment (see FF 9—12; see also Ans. 3—6).
Therefore, we are not persuaded by Appellant’s contention that “the
microbeads in Shuler and the various materials such as microbeads and
hollow fibers in Hamzeh function as a mere substrate for growing a cell or
tissue — not to transport the solution as in [Appellant’s] claimed invention,
which has fibers which are not only hollow but porous as well” (App. Br.
10).
We are not persuaded by Appellant’s contention that:
[T]here is no structure in Hamzeh nor Schuler, which provides
connective tubing for a first and second cartridge wherein the
solution is passed through the pores of the hollow fiber and the
cell or tissue in the extra capillary space of the first cartridge and
then run through the pores of the hollow fiber and through the
connective tubing into the cell or tissue of the second cartridge
to determine the effect of the chemical or agent on the two
different types of cells or tissues in sequence as claimed.
(App. Br. 10; cf. FF 1—14; see Ans. 6—10.)
We are not persuaded by Appellant’s contention that: “Shuler and
Hamzeh do not teach . . . passing a solution through . . . cells or tissue, but
rather . . . passing a solution over the cells or tissue” and “Schuler and
Hamzeh do not teach a cartridge system with two cartridges with connective
tubing that would even permit this type of functionality” (App. Br. 10).
Notwithstanding Appellant’s contention to the contrary, the evidence of
record establishes that the combination of Schuler and Hamzeh suggest a
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system comprising more than one hollow, porous, fiber cartridges, which
contain different cell types, wherein the cartridges allow fluid to interact
with cells, in such a way that cells may take up fluids and excrete fluids and
cellular products in a manner that simulates a human or animal tissue system
(FF 1—14; see Ans. 10-13).
Notwithstanding Appellant’s contention to the contrary, we find no
requirement in Appellant’s claim 29 that requires “at least one layer of cells”
(Reply Br. 3; see id. at 3—5). Therefore, we are not persuaded by
Appellant’s contentions regarding a layer of cells (Reply Br. 3—5).
Claim 31\
We are not persuaded by Appellant’s contention that the combination
of Shuler and Hamzeh fails to “disclose a cartridge system wherein the
system is configured to test at least two chemicals and/or agents
simultaneously as claimed” (App. Br. 11; cf. FF 5; see Ans. 13—14).
Shuler discloses a system that makes use of hollow fiber units that
may be of the type known to those of ordinary skill in this art, such as those
disclosed by Hamzeh (see FF 6—7 and 9—13). Therefore, notwithstanding
Appellant’s contention to the contrary, Examiner provided a reason to
modify Shuler with Hamzeh’s porous hollow fiber cartridges (see App. Br.
12 (“Examiner has not given any credible reason, suggestion, or motivation
in the references or external to the references, or from Shuler or Hamzeh
cited as a whole for the person of ordinary skill to have combined or
modified the references”); cf. Ans. 14—15). For the same reason, we are not
persuaded by Appellant’s contention that Hamzeh’s bioreactors are not
equivalent to Shuler’s (App. Br. 12; cf. Ans. 15—16).
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Appellant fails to identify any evidentiary basis on this record to
support a conclusion that “the hollow fibers and cartridges in Hamzeh are
not equivalent to the hollow and porous fibers in the claimed invention”
(App. Br. 12; cf FF 10—12). In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir.
1997) (argument by counsel cannot take the place of evidence).
We are not persuaded by Appellant’s contention that the combination
of Shuler and Hamzeh fails to suggest “hollow fiber units allow[] an in vitro
system to mimic/simulate the in vivo capillary system of the tissue” (App.
Br. 12; cf. FF 4 ((“Each chamber [of Shuler’s system] contains a cell type of
the organ it is intended to simulate”); FF 13 (Hamzeh’s “bioreactor
simulates a human or animal tissue system”); see Ans. 16).
The combination of Shuler, Hamzeh, and Tolbert
Based on the combination of Shuler, Hamzeh, and Tolbert, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious
to have the at least one hollow and porous fiber running through
a portion or the entire length of each cartridge have an inner
diameter above 300 micrometers, since it has been held that
where the general conditions of a claim are disclosed in the prior
art, discovering the optimum or workable ranges involves only
routine skill in the art.
(Final Act. 16.) See In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here
the general conditions of a claim are disclosed in the prior art, it is not
inventive to discover the optimum or workable ranges by routine
experimentation”).
We are not persuaded by Appellant’s unsupported assertion that “one
skilled in the art would understand the tubes in Tolbert would not be
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considered a fiber albeit a large one as claimed” (App. Br. 13; cf. FF 14; see
Ans. 17—18). See In re Geisler, 116 F.3d at 1471.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claims 29 and 31 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Shuler and Hamzeh is affirmed.
Claim 30 is not separately argued and falls with claim 29. Claims 29—31
stand rejected under 35 U.S.C. § 103(a) as unpatentable over the
combination of Shuler and Hamzeh.
The rejection of claim 33 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Shuler, Hamzeh, and Tolbert is affirmed. Claim 34
is not separately argued and falls with claim 33.
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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