Ex Parte Anderson et al

Board of Patent Appeals and Interferences

Jul 7, 2010

11538608 (B.P.A.I. Jul. 7, 2010)

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.
11/538,608 10/04/2006 Diane Lee Anderson 13461.0052.CNUS03 2306
23369 7590 07/07/2010
HOWREY LLP-HN
C/O IP DOCKETING DEPARTMENT
2941 FAIRVIEW PARK DRIVE, SUITE 200
FALLS CHURCH, VA 22042-7195
EXAMINER
LI, QIAN JANICE
ART UNIT PAPER NUMBER
1633
MAIL DATE DELIVERY MODE
07/07/2010 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 DIANE LEE ANDERSON, JOHN PAUL RANIERI, MAURIZIO
CAPOGROSSI COLOGNESI, MARCO SCOCCIANTI, and
ANTONIO FACCHIANO
__________

Appeal 2009-015033
Application 11/538,608
Technology Center 1600
__________

Decided: July 7, 2010
__________

Before ERIC GRIMES, TONI R. SCHEINER, and DEMETRA J. MILLS,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of implanting a prosthetic blood vessel, which the Examiner has rejected for
lack of enablement. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.

Appeal 2009-015033
Application 11,538,608

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STATEMENT OF THE CASE
Claims 104-120 are on appeal. Claim 104 is the broadest independent
claim and reads as follows:
104. A method of implanting a prosthetic graft for containment of
blood flow into a patient, comprising:
implanting into the patient a prosthetic graft comprising (a) a porous
prosthetic implant for containing blood in vivo, said prosthetic implant
having an outer surface that is not in contact with blood flow in vivo and an
inner surface that is in contact with blood flow in vivo, said inner surface
defining an interior space for containment of blood flow, and (b) adherent
cells adhered to the outer surface of said porous prosthetic implant, wherein
said adherent cells are not seeded on the inner surface of said porous
prosthetic implant, wherein said adherent cells are transfected with at least
one recombinant nucleic acid molecule operatively linked to a transcription
control sequence, said recombinant nucleic acid molecule encoding a protein
that enhances patency of the prosthetic implant.

Issue
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 112, first paragraph, on the basis that the Specification does not provide
enablement for enhancing patency of a prosthetic graft for containment of
blood flow in vivo “1) by implanting undifferentiated stem cells or
embryonic stem cells as the adherent cells; or 2) by using immunogenic
(allogeneic or xenogeneic) cells as the adherent cells” (Ans. 4). The
Examiner reasons that
it was well known in the art that undifferentiated, particularly
embryonic stem cells have yet to be applied in a clinical setting
because they could indefinitely proliferate, differentiate to all
lineages of cell types, and their tendency to form teratoma. . . .
Such a tumor would [be] likely to obstruct or even close the
vascular graft, and hence reduce rather than enhance the
patency of the vascular graft.
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Application 11,538,608

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(Id. at 6-7.) With regard to immunogenic cells, the Examiner reasons that
“using allogeneic and xenogeneic cells as adherent cells in the instantly
claimed invention would almost certainly induce a strong graft rejection
response, which would reduce rather than enhance the patency of the
prosthetic vascular graft” (id. at 9).
Appellants contend that the Specification is fully enabling for the
method defined by the claims (Appeal Br. 12) and the Examiner’s rejection
is based on safety and efficacy concerns (id. at 13, 15) rather than whether
the Specification adequately enables a skilled worker to practice the method
that is claimed (id. at 16).
The issue presented is: Do the Examiner’s concerns about the effects
of using undifferentiated cells or immunogenic cells in the claimed method
support a conclusion that the full scope of the claimed method could not be
practiced without undue experimentation?
Principles of Law
“Enablement does not require an inventor to meet lofty standards for
success in the commercial marketplace. Title 35 does not require that a
patent disclosure enable one of ordinary skill in the art to make and use a
perfected, commercially viable embodiment absent a claim limitation to that
effect.” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir.
2003).
“There is nothing in the patent statute . . . which gives the Patent
Office the right or the duty to require an applicant to prove that compounds
or other materials which he is claiming, and which he has stated are useful
for ‘pharmaceutical applications,’ are safe, effective, and reliable for use
with humans.” In re Krimmel, 292 F.2d 948, 954 (CCPA 1961).
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Application 11,538,608

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Analysis
The Examiner has rejected the claims on the basis that the
Specification does not enable practicing the claimed method with
undifferentiated cells or immunogenic cells. The Examiner, however, has
not provided any evidence or reasoning based on science or logic for
concluding that the steps recited in the claims – transfecting cells with
recombinant nucleic acids, adhering the transfected cells to the outside of a
porous prosthetic implant, and implanting the modified implant in a patient –
would have required undue experimentation to carry out if the cells are
undifferentiated or immunogenic. Nor has the Examiner provided a basis
for concluding that the process would not result in “containment of blood
flow in[] a patient,” as recited in the preamble of claim 104, if
undifferentiated or immunogenic cells were used.
Rather, the Examiner’s basis for rejecting the claims is that, if the
claimed process was carried out using undifferentiated or immunogenic
cells, the implanted prosthesis might, over time, give rise to complications
that a patient would rather avoid. Whether a claimed method is enabled,
however, is a different question from whether a particular embodiment of a
claimed method is the best way to achieve the desired result, or whether it
would be a good idea to carry out a claimed method in a particular way. A
claim is enabled if a skilled worker can carry out the recited steps and
achieve the stated result, without undue experimentation. Long-term clinical
effectiveness is not required, absent a claim limitation to that effect.
The Examiner has not provided an adequate basis for concluding that
the claimed process could not be carried out using undifferentiated cells or
immunogenic cells, or that the resulting prosthesis would not provide
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Application 11,538,608

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containment of blood flow in a patient, at least until such time as the
prosthesis is rejected by the patient or blocked by a teratoma.1 The
Examiner therefore has not established that the claimed method is not
enabled by the Specification.
Conclusion of Law
The Examiner’s concerns about the effects of using undifferentiated
cells or immunogenic cells in the claimed method do not support a
conclusion that the full scope of the claimed method could not be practiced
without undue experimentation.
SUMMARY
We reverse the rejection of claims 104-120 under 35 U.S.C. § 112,
first paragraph, based on lack of enablement.

REVERSED

lp

1 We also note that claim 104 is open to other steps not expressly recited,
such as administering an immunosuppressant to the patient or treating the
adhered undifferentiated cells to cause them to differentiate before the
prosthesis is implanted into a patient.
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Application 11,538,608

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HOWREY LLP-HN
C/O IP DOCKETING DEPARTMENT
2941 FAIRVIEW PARK DRIVE, SUITE 200
FALLS CHURCH VA 22042-7195