Ex Parte Poo et al

Board of Patent Appeals and Interferences

May 25, 2011

10410954 (B.P.A.I. May. 25, 2011)

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.
10/410,954 04/10/2003 Ramon E. Poo 7130-11 6736
86000 7590 05/26/2011
Gregory A. Nelson
Novak Druce & Quigg LLP
525 Okeechobee Blvd
Suite 1500
West Palm Beach, FL 33401
EXAMINER
WARE, DEBORAH K
ART UNIT PAPER NUMBER
1651
MAIL DATE DELIVERY MODE
05/26/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RAMON E. POO and CAMILLO RICORDI
__________

Appeal 2010-008816
Application 10/410,954
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for new matter and for obviousness. We have jurisdiction under
35 U.S.C. § 6(b).
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STATEMENT OF CASE
The following claim is representative.
1. A method for storing organs, cells, and tissues, comprising the steps of:
providing a gas impermeable solution container;
providing a transportation solution having at least one organ-preserving
compound;
pre-oxygenating said transportation solution with an organ-preserving
amount of dissolved oxygen;
placing the pre-oxygenated transportation solution into a plurality of said
solution containers;
hermetically sealing said solution containers with said pre-oxygenated
transportation solution there within;
distributing said solution containers to different locations;
storing said pre-oxygenated transportation solution in said solution
containers at said different locations;
removing said transportation solution from said solution containers at the
location and at the time that an organ, cell, or tissue is to be preserved; and
placing said transportation solution and said organ, cell, or tissue into an
organ transportation container;
sealing said organ transportation container; and,
transporting said organ, cell or tissue in said pre-oxygenated transportation
solution in said organ transportation container.

Cited References
Klatz et al. US 5,752,929 May 19, 1998
Walsh US 6,490,880 B1 Dec. 10, 2002

Grounds of Rejection
1. Claims 1-3 and 8 are rejected under 35 U.S.C. § 112, first paragraph for failing
to comply with the written description requirement for new matter.
2. Claims 1-3 and 8 are rejected under 35 U.S.C. § 103(a) for obviousness over
Walsh in view of Klatz.

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Discussion
Claims 1-3 and 8 are rejected under 35 U.S.C. § 112, first paragraph for
failing to comply with the written description requirement for new matter.
The Examiner finds that there is no support in the original disclosure for
removing the solution by breaking the container with the organ preservation
solution. (Ans. 4.)
Appellants admit that breaking the bag containing the organ preservation
solution is not specifically disclosed in the Specification, however, Appellants
argue that one skilled in the art would readily appreciate that a sealed bag can be
broken to remove the contents. (App. Br. 6.) Therefore, the issue is: does the
Specification as filed support the pending claim scope.
The “written description” requirement . . . serves both to satisfy
the inventor’s obligation to disclose the technologic knowledge upon
which the patent is based, and to demonstrate that the patentee was in
possession of the invention that is claimed. . . .
The descriptive text needed to meet these requirements varies
with the nature and scope of the invention at issue, and with the
scientific and technologic knowledge already in existence.

Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). “[A] description that
merely renders the invention obvious does not satisfy the [written description]
requirement.” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336,
1352 (Fed. Cir. 2010).
We are not persuaded by Appellants’ argument. The Specification discloses
that the bag is prefilled and sealed. (Spec., ¶ [0009].) The Specification further
states that the containers are rapidly filled with the preoxygenated solution by
adding the preoxygenated solution. (Id.) One of ordinary skill in the art would
understand that the seal would not necessarily have to be broken to remove the
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preoxygenated solution form the bag. For example, there could be a valve present
to release the solution under pressure, there could be a separate access point to the
inner bag, or other methods for removing liquid from a sealed bag. Thus, breaking
the bag is merely one obvious choice, but is not described by the Specification.
For this reason, the written description does not evidence that Appellants
were in possession of the invention as claimed and the new matter rejection is
affirmed.

2. Claims 1-3 and 8 are rejected under 35 U.S.C. § 103(a) for obviousness over
Walsh in view of Klatz.

FINDINGS OF FACT
The findings of fact relevant to the rejection are set forth below.
1.
Walsh teaches providing a gas impermeable, solution container
(e.g. bag) and transportation organ container (see abstract, and column
4, lines 49-52) having at least one organ-preserving compound, pre-
oxygenating the solution (column 2, lines 8-15 and 65-67) and placing
it into a solution container (e.g. bag), sealing the container(s) (column
4, lines 60-62) and distributing them to locations such as operating
room environments (column 4, lines 49-52, column 5, lines 10-25 and
column 6, lines 1-10); in addition, capable of storing them at those
locations.

(Ans. 4-5.)
2. Walsh teaches “removing at the location and also placing the solution and
organ, cell or tissue into an organ transportation container and sealing it to
transport the organ, cell or tissue are also disclosed (column 5, lines 10-23).” (Id. at
5.)
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3.
The disclosed inner container of Walsh is an organ container
and/or organ transportation container and the disclosed bag is a
solution container of which both these containers can serve the same
function, note column 5, lines 20-21. The UW solution is disclosed at
column 2, line 13, and perfluorocarbon at column 2, line 25-30, as
components of a preservation medium. Also, a dual preservation
medium is disclosed and the perfluorocarbon is taught to reduce the
cost of such media, note column 5, lines 7-9. UW solution is disclosed
to be useful for perfusing oxygen to an organ, note column 2, lines 12-
13. Perfluorocarbon is disclosed to be an oxygen carrier, note column
4, lines 55-56.

(Ans. 5.)
4. “Klatz et al teach a preoxygenated solution for preserving an organ, note column
8, lines 65-66.” (Id.) Klatz states that reservoirs containing a preoxygenated
solution eliminate the need for oxygen tanks. (Col. 8, l. 65 - col. 9, l. 1.)
5. “The claims differ from Walsh in that a pre-oxygenating step of a transportation
solution (e.g. preservation solution) with dissolved oxygen is not clearly
disclosed.” (Ans. 5.)
6. The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the claimed invention was made to provide for a dual
preservation medium containing dissolved oxygen as disclosed by
Walsh by pre-oxygenating it as disclosed by Klatz et al because
Walsh and Klatz clearly teach that an oxygen environment for organ
transport is desirable.
Further, it would have been obvious to provide for a bag as the
solution container since it would have been expected to be easily
breakable and impermeable to gas by one of ordinary skill in the art.
Also to pre-oxygenate the transportation solution (e.g. preservation
solution) would have been obvious to one of skill in the art because
the reference(s) teach that maintaining an organ or tissue in an
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oxygenated environment improves viability, note Walsh at column 2,
lines 9-10.

(Id. at 5-6.)
7.
UW solution and perfluorocarbon are disclosed to be useful for
organ transport and to provide for them in a dual layer transportation
solution to be contained within a plurality of solution containers is
clearly an obvious modification of the cited prior art. Also to provide
an air tight seal to said solution containers is clearly an obvious step
because Walsh clearly recognized the need to seal the containers for
effective transport and storage of organs at different locations.

(Ans. 6.)
8.
Breaking the bag at the location would have been an expected
and effective way to remove the transportation solution at the desired
location and save time for its use to preserve the organ, tissue or cells
upon placement in the organ transportation container. Furthermore, to
seal the organ transportation container before transportation of the
organ, tissue or cells is disclosed or at least suggested by the cited
prior art. Each of the three main critical features are disclosed: oxygen
carrying solution (e.g. oxygen containing solution), solution container,
and organ transport container.

(Id.)
9. The Declaration under 37 C.F.R. 1.132 of Dr. Camillo Ricordi
1
states that there
is a significant and long felt need in the art for a preoxygenated transportation
solution sealed within and available for use at any time. (Decl. ¶ 6.)

1
Declaration of Dr. Camillo Ricordi, M.D, submitted December 12, 2007.
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Discussion
ISSUE
The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the claimed invention was made to provide for a dual
preservation medium containing dissolved oxygen as disclosed by
Walsh by pre-oxygenating it as disclosed by Klatz et al. because
Walsh and Klatz clearly teach that an oxygen environment for organ
transport is desirable.
Further, it would have been obvious to provide for a bag as the
solution container since it would have been expected to be easily
breakable and impermeable to gas by one of ordinary skill in the art.
Also to pre-oxygenate the transportation solution (e.g. preservation
solution) would have been obvious to one of skill in the art because
the reference(s) teach that maintaining an organ or tissue in an
oxygenated environment improves viability, note Walsh at column 2,
lines 9-10.

(Ans. 5-6.)
Appellants argue that Walsh does not disclose a solution container with a
pre-oxygenated preservation solution that has been placed within the solution
container and sealed. Appellants argue that Klatz is directed to a method of
preserving a cadaver in which a preoxygenated solution is injected directly into the
cadaver and thus storing a preoxygenated solution in a container is not disclosed.
(Reply Br. 5.)
The issue is: Does the cited prior art disclose a solution container with pre-
oxygenated preservation solution that has been placed within the solution container
and sealed as claimed?

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PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is met,
does the burden of coming forward with evidence or argument shift to the
applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted).
In order to determine whether a prima facie case of obviousness has been
established, we consider the factors set forth in Graham v. John Deere Co., 383
U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences
between the prior art and the claims at issue; (3) the level of ordinary skill in the
relevant art; and (4) objective evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods is likely
to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007).
Whether an invention satisfied a long-felt need, and what relevance that has
to obviousness, must be considered in light of the state of the art at the time the
invention was made: whether an invention satisfied a long-felt need has little
relevance to obviousness if the means for satisfying that need became available in
the art only recently. See, e.g., Graham vs. John Deere Co., 383 U.S. at 36.

ANALYSIS
We agree with the Examiner’s fact finding (see Ans. 4-7). We provide the
following additional comment.
For the reasons of record, we are not persuaded by Appellants’ argument.
In particular, Walsh discloses that it is known that “maintaining the organ or tissue
in an oxygenated environment improves viability.” (Col. 2, ll. 8-10.) Walsh
discloses placing an organ preservation solution in a container. (Col. 2, l. 58- col.
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3, l. 4.) Klatz discloses a reservoir which contains an organ preservation solution.
(Col. 5, ll. 52-53.) In an alternative embodiment a preoxygenated organ
preservation solution may be present in the reservoir to eliminate the need for
oxygen tanks. (Col. 8. l. 65 to col. 9, l. 1.) Thus, it would have been obvious to
substitute the preoxygenated organ preservation solution in a reservoir as in Klatz
for the container of Walsh in order to eliminate the need for oxygen tanks.
Appellants put forth the Declaration of Dr. Ricordi as evidence of long felt
need in the art for the claimed invention. Appellants state that the prior art method
of oxygenating an organ preservation solution involves streaming oxygen into the
preservation solution which can take as much as 20-30 minutes. (App. Br. 4.) Dr.
Ricordi reiterates that a preservation solution is provided unoxygenated and is
oxygenated, presumably by oxygen tanks, just prior to the time the organ is
immersed. (Decl. ¶ 5.) Klatz, however, evidences that it was known in the art that
preoxygenation of the preservation solution eliminates the need for oxygen tanks.
So while Dr. Ricordi argues that the claimed invention meets a long felt need, this
need has, in fact, been met in the prior art by the preoxygenated preservation
solution of Klatz.
The obviousness rejection is affirmed.

CONCLUSION OF LAW
The new matter rejection is reversed. The cited references support the
Examiner’s obviousness rejection which has not been rebutted by Appellants with
sufficient evidence.

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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

DJM
JNF
DEA

cdc