BioGatekeeper, Inc.v.Kyoto University

Patent Trial and Appeal Board

Feb 11, 2015

12457356 (P.T.A.B. Feb. 11, 2015)

Trials@uspto.gov Paper 12
Tel: 571-272-7822 Entered: February 11, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
BIOGATEKEEPER, INC.,
Petitioner,

v.

KYOTO UNIVERSITY,
Patent Owner.
_______________

Case IPR2014-01286
Patent 8,058,065 B2
_______________

Before JACQUELINE W. BONILLA, SHERIDAN K. SNEDDEN, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. INTRODUCTION
BioGatekeeper, Inc. (“BioGatekeeper”) filed a corrected Petition to institute
an inter partes review of claim 1 (Paper 6; “Pet.”) of U.S. Pat. No. 8,058,065 B2 (Ex.
1001; “the ’065 patent”). Kyoto University (“the University”) filed a Patent Owner
Preliminary Response. Paper 10 (“Prelim. Resp.”).
We have jurisdiction under 35 U.S.C. § 314. The standard for instituting an
inter partes review is set forth in 35 U.S.C. § 314(a), which states that an inter
partes review may not be instituted unless “the information presented in the
[Petition and Preliminary Response] shows that there is a reasonable likelihood
that the petitioner would prevail with respect to at least 1 of the claims challenged
in the petition.” Upon consideration of the above-mentioned Petition and
Preliminary Response, we conclude that BioGatekeeper has failed to establish that
there is a reasonable likelihood that it would prevail with respect to its challenge of
claim 1. We, therefore, decline to institute an inter partes review as to claim 1 of
the ’065 patent.
A. The ’065 patent (Ex. 1001)
The ’065 patent discloses a method for nuclear “reprogramming [of] a
differentiated somatic cell to derive an induced pluripotent stem (iPS) cell.” Ex.
1001, Abstract. The nuclear reprogramming of a somatic cell, such as a fibroblast
cell, is accomplished by introducing to the somatic cell one or more gene products
from the following gene families: an Oct family gene, a Klf family gene, a Myc
family gene, or a Sox family gene. Id. at 3:11–24.
B. Claim 1 of the ’065 Patent
Challenged claim 1 is the sole claim of the’065 patent and provides as
follows:
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1. A method for preparing an induced pluripotent stem cell by nuclear
reprogramming of a somatic cell from a mammalian species,
comprising:
a) introducing into the somatic cell one or more retroviral vectors
comprising a gene encoding Oct3/4, a gene encoding Klf4, a gene
encoding c-Myc and a gene encoding Sox2 operably linked to a
promoter; and
b) culturing the transduced somatic cell on a fibroblast feeder layer or
extracellular matrix in a cell media that supports growth of ES
1
cells
of the mammalian species, wherein one or more pluripotent cells are
obtained.
C. The Prior Art
BioGatekeeper relies upon the following prior art references as its basis for
challenging claim 1 of the ’065 patent.
Reference Patents/Printed Publications Exhibit
Jaenisch
2

U.S. Pat. No. 7,682,828 B2, issued Mar. 23, 2010,
filed Nov. 24, 2004
Ex. 1002
Benvenisty
N. Benvenisty et al., An embryonically expressed
gene is a target for c-Myc regulation via the c-Myc-
binding sequence, 6 GENES DEV. 2513–2523 (1992).
Ex. 1003
Li
Yanjun Li et al., Murine embryonic stem cell
differentiation is promoted by SOCS-3 and
inhibited by the zinc finger transcription factor Klf4,
105(2) BLOOD 635–637 (2005).
Ex. 1004

D. The Asserted Ground
BioGatekeeper challenges claim 1 of the ’065 patent as obvious under
35 U.S.C. § 103 over the combination of Jaenisch, Benvenisty, and Li.

1
ES stands for “embryonic stem.”
2
Jaenisch is referred to as the “Whitehead Patent” in the Petition. Pet. 4.
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II. ANALYSIS
A. Claim Interpretation
We interpret claims in an unexpired patent using the “broadest reasonable
construction in light of the specification of the patent in which [they] appear[].” 37
C.F.R. § 42.100(b); see also Office Patent Trial Practice Guide, 77 Fed. Reg.
48,756, 48,766 (Aug. 14, 2012). Under the broadest reasonable construction
standard, claim terms are given their ordinary and customary meaning, as would be
understood by one of ordinary skill in the art at the time of the invention. In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). “Absent claim
language carrying a narrow meaning, the PTO should only limit the claim based on
the specification . . . when [it] expressly disclaim[s] the broader definition.” In re
Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). “Although an inventor is indeed free
to define the specific terms used to describe his or her invention, this must be done
with reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d
1475, 1480 (Fed. Cir. 1994).
None of the claim terms requires explicit construction for purposes of this
decision. See Pet. 9–10; Prelim. Resp. 30–32.
B. Principles of Law
An invention is obvious if “the differences between the subject matter
sought to be patented and the prior art are such that the subject matter as a whole
would have been obvious . . . to a person having ordinary skill in the art to which
said subject matter pertains.” 35 U.S.C. § 103. The question of obviousness is
resolved on the basis of underlying factual determinations including: (1) the scope
and content of the prior art; (2) any differences between the claimed subject matter
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and the prior art; (3) the level of skill in the art; and (4) where in evidence, so-
called secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18
(1966); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 399 (2007) (“While
the sequence of these questions might be reordered in any particular case, the
[Graham] factors continue to define the inquiry that controls.”). When determining
whether a patent claiming a combination of known elements would have been
obvious, we “must ask whether the improvement is more than the predictable use
of prior art elements according to their established functions.” Id. at 417. This
inquiry is factual in nature. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165
(Fed. Cir. 2006) (explaining that whether there is “a reasonable expectation of
success in making the invention via” a combination of prior art elements is a
question of fact). A reasonable expectation of success is assessed from the
perspective of one of ordinary skill in the art at the time the invention was made.
Life Techs., Inc. v. Clontech Labs., Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000).
The “prior art fails to provide the requisite ‘reasonable expectation’ of
success where it teaches merely pursuit of a ‘general approach that seemed to be a
promising field of experimentation, where the prior art gave only general guidance
as to the particular form of the claimed invention or how to achieve it.’”
Medichem, 437 F.3d at 1165 (quoting In re O’Farrell, 853 F.2d 894, 903–04 (Fed.
Cir. 1988)). In such cases, “courts should not succumb to hindsight claims of
obviousness.” In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).
C. Obviousness of Claim 1 Over the Combination of Jaenisch, Benvenisty, and
Li
BioGatekeeper contends that claim 1 of the ’065 patent is unpatentable
under 35 U.S.C. § 103(a) as obvious over the combination of Jaenisch, Benvenisty,
and Li. BioGatekeeper contends that Jaenisch describes a method for nuclear
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reprogramming of an animal somatic cell into a pluripotent or multipotent cell.
Pet. 17 (citing Ex. 1002, 17:8–23, 9:4–8). BioGatekeeper contends further that
Jaenisch describes that reprogrammed pluripotent somatic cells may be achieved
by introducing, into a somatic cell, at least two pluripotent genes and directs our
attention to the following passage from Jaenisch:
A reprogramming agent may belong to any one of many different
categories. For example, a reprogramming agent may be a chromatin
remodeling agent . . . a pluripotency protein, including, for example,
Nanog, Oct-4 and Stella. Such an agent may also be a gene essential
for pluripotency, including, for example, Sox2, FoxD3, and LIF, and
Stat3.
Id. at 17–18 (citing Ex. 1002, 12:26–39).
BioGatekeeper acknowledges that Jaenisch does not explicitly disclose using
a klf4 gene and a c-myc gene, as required by claim 1, but contends that Benvenisty
and Li are within the same field and identify the c-myc and klf4 genes,
respectively, as pluripotent genes. Id. at 15–16 (claim chart), 18. BioGatekeeper
reasons that it would have been obvious to one of ordinary skill to modify Jaenisch
“by additionally or alternatively introducing the c-myc gene and the Klf4 gene,
because these two genes qualify and were known as pluripotency genes as defined
by [Jaenisch], in order to reprogram a somatic cell to achieve either a complete set
or a subset of pluripotent characteristics.” Id. at 19.
The University responds by arguing that BioGatekeeper has not
demonstrated the obviousness of the claim 1 and has not sufficiently established
Jaenisch as prior art. Prelim. Resp. 13–28. The University also presents objective
evidence of nonobviousness. Id. at 30.
Upon consideration of the information presented in the Petition and
Preliminary Response, we conclude that BioGatekeeper has failed to establish that
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the subject matter recited in claim 1 would have been obvious to a person of
ordinary skill in the art. The information presented by BioGatekeeper may be
sufficient to establish that each of the genes recited in claim 1 were known;
however, the Petition lacks sufficient information to support a determination that a
person of ordinary skill in the art would have had a reasonable expectation of
success in achieving pluripotency of a mammalian stem cell using the specific
combination of genes recited in claim 1.
At best, the Petition directs us to general guidance in the prior art with
regard to particular genes involved in cell differentiation and cell division, but fails
to point us to specific guidance as to how, for example, the recited genes would
function together at the appropriate developmental stage of the cells to achieve
pluripotency. Pet. 15–18. Such general guidance as provided in the Petition does
not establish a reasonable likelihood that Petitioner would show the requisite
“reasonable expectation” of success for combining a particular set of genes in
order to achieve nuclear reprogramming of a mammalian somatic cell to produce
an induced pluripotent stem cell. Medichem, 437 F.3d at 1165.
Furthermore, BioGatekeeper’s stated rationale indicates, at best, that the
prior art references are each analogous art to the invention of the ’065 patent, and
perhaps, to each other. Notably absent from BioGatekeeper’s stated rationale,
however, is a sufficient explanation of how or why teachings in the references
would have been combined, from the perspective of one with ordinary skill in the
art, to arrive at the claimed invention. For example, BioGatekeeper contends that
Benvenisty discloses c-myc as a pluripotent gene, but fails to indicate where
Benvenisty provides such a teaching. Pet. 15. BioGatekeeper does not identify
where Benvenisty describes c-myc as a pluripotent gene, let alone a “gene essential
for pluripotency” such as those referenced in Jaenisch. In fact, BioGatekeeper
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admits that “the Benvenisty article and the Li article do not specifically call the c-
myc gene and the klf4 gene pluripotency genes[.]” Pet. 19. Rather, Benvenisty
describes c-myc as a proto-oncogene “thought to play a significant role in the
physiology of cell division and differentiation” that is expressed in certain
embryonic and adult tissues. Ex. 1003, Abstract, 2513 (internal citation omitted).
The Petition lacks a sufficiently articulated reason as to why a person of ordinary
skill in the art would have selected the proto-oncogene c-myc in order to achieve
the claimed subject matter.
Jaenisch is relied upon by Petitioner for the disclosure of the oct4 and sox2
genes. Pet. 15. Li is relied upon by Petitioner for the disclosure of the klf4 gene.
Id. Accordingly, neither Jaenisch nor Li cure the deficiency of Benvenisty
exemplified above.
In view of the above, we conclude that BioGatekeeper has not established a
reasonable likelihood that it would prevail in showing that independent claim of
the ’065 patent would have been obvious under 35 U.S.C. § 103(a) over the
combination of Jaenisch, Benvenisty, and Li.
D. Real Party-in-Interest
Patent Owner argues that the Petition fails to adequately identify the real
party-in-interest. Prelim. Resp. 7–12. We conclude that the information presented
in the Petition fails to show that there is a reasonable likelihood that the Petitioner
would prevail with respect to its challenge of claim 1 of the ’065 patent.
Therefore, we do not reach the issues raised by Patent Owner’s argument with
respect to real party-in-interest.
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III. CONCLUSION
The Petition does not persuade us that there is a reasonable likelihood that
the challenged claim 1 is unpatentable based on the asserted ground. We decline to
institute an inter partes review of claim 1 under 35 U.S.C. § 103(a) as obvious
over the combination of Jaenisch, Benvenisty, and Li. 37 C.F.R. § 42.108(c).
IV. ORDER
For the reasons given, it is
ORDERED that the petition is denied as to the challenged claim, and no trial
is instituted.

PETITIONER:
Anthony S. King
aking@ardentlawgroup.com

PATENT OWNER:
Kerry Taylor
2KST@knobbe.com

Brenton Babcock
2brb@knobbe.com

Dan Altman
2dea@knobbe.com