Ex Parte Xu

Board of Patent Appeals and Interferences

Apr 28, 2008

10193884 (B.P.A.I. Apr. 28, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte
CHUNHUI XU
__________

Appeal 2008-05851
Application 10/193,884
Technology Center 1600
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Decided: April 28, 2008
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Before TONI R. SCHEINER, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
for production of human cardiomyocytes from human embryonic stem cells.
The Examiner has rejected the claims as lacking utility, lacking enablement,
and anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Heard April 17, 2008.
Appeal 2008-0585
Application 10/193,884

BACKGROUND
“A central challenge for research in regenerative medicine is to
develop cell compositions that can help reconstitute cardiac function” (Spec.
2: 22-23). The claimed invention is directed to a “system that permits highly
enriched populations of cardiomyocyte lineage cells to be obtained” (Spec.
8: 12-13) from human embryonic stem cells (Spec. 9: 17-18). According to
the Specification, human cardiomyocytes or cardiomyocyte precursors
differentiated from human embryonic stem cells may be used for “screening
a compound for an effect on cardiomyocytes” (Spec. 5: 30-31), and may also
“be formulated as a medicament for treating a condition of the heart” (Spec.
5: 35-36), e.g., by “reconstituting or supplementing contractile activity in
cardiac tissue” (Spec. 5: 37).
DISCUSSION
Claims 16-23, all the claims remaining in the application, are on
appeal. Claim 16 is representative and reads as follows:
16. A system for the production of human cardiomyocytes from human
stem cells comprising:
a first isolated cell population comprising at least 0.56 x 106 cells
differentiated in vitro from a portion of a population of human embryonic
stem cells,
wherein the first cell population proliferates in culture and comprises
at least 5% cardiomyocytes, identifiable by the criteria that they have
spontaneous periodic contractile activity and express at least one of the
following markers from an endogenous gene:
cardiac troponin I (cTnI), cardiac troponin T (cTnT), or atrial
natriuretic factor (ANF); and
a second isolated cell population comprising said human embryonic
stem cells,
wherein the second isolated population can produce more human
cardiomyocytes by in vitro differentiation.
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Application 10/193,884

The claims stand rejected as follows:

I. Claims 16-23 under 35 U.S.C. § 101, as lacking patentable utility.

II. Claims 16-23 under 35 U.S.C. § 112, first paragraph, as lacking
enablement.

III. Claims 16-22 under 35 U.S.C. § 102(a), as anticipated by Thompson
(U.S. patent 5,843,780, December 1, 1998) and Li (R-K Li et al.,
Isolation of Cardiomyocytes from Human Myocardium for Primary
Cell Culturing, 15 J. Tiss. Cult. Meth. 147-154 (1993)), “as evidenced
by Khamsi” (Roxanne Khamsi, Map of DNA Differences Will Help
Experts Tailor Drugs, news@nature.com, published online October
26, 2005).

IV. Claims 16-22 under 35 U.S.C. § 102(b), as anticipated by, or under
35 U.S.C. § 103(a) as obvious over Li.

Utility
The Examiner rejected claims 16-23 under 35 U.S.C. § 101, “because
the claimed invention is not supported by either a substantial or specific
asserted utility or a well established utility” (Ans. 3).
Section 101 requires a utility that is both substantial and specific. In
re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005). A substantial utility is one
that “show[s] that an invention is useful to the public as disclosed in its
current form, not that it may prove useful at some future date after further
research. Simply put, to satisfy the ‘substantial’ utility requirement, an
asserted use must show that that claimed invention has a significant and
presently available benefit to the public.” Id. A specific utility is one
“which is not so vague as to be meaningless.” Id. In other words, “in
addition to providing a ‘substantial’ utility, an asserted use must show that
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Application 10/193,884

that claimed invention can be used to provide a well-defined and particular
benefit to the public.” Id.
The Examiner finds that “[t]he claims are directed to a system
comprising two cell types: a first isolated cell population . . . differentiated
in vitro from a portion of a population of human embryonic stem (hES) cells
. . . and a second isolated cell population comprising said human embryonic
stem cells” (Ans. 3-4). The Examiner further finds that “the system is for
the production of the first population of cells, the human cardiomyocytes,
from the second population of cells, the human embryonic stem cells” (Ans.
4).
The Examiner acknowledges that “the specification provides a clear
utility[ ]2 for each of the separate cell populations” (Ans. 4), but nevertheless
contends that “these are not specific or substantial utilities for the system
comprising the two isolated cell [types], but [separate] utilities for each of
the cell populations” (Ans. 4).
We will reverse this rejection. The claimed system generates
cardiomyocytes from human embryonic stem cells. Given the Examiner’s
finding that human cardiomyoctes have “a clear utility” (Ans. 4), it logically
follows that a system that generates these useful human cardiomyocytes has
a “clear,” “substantial,” and “specific” utility as well.
Accordingly, the rejection of claims 16-23 under 35 U.S.C. § 101 is
reversed.

2 The Examiner appears to use the term “clear utility” interchangeably with
the term “substantial or specific utility” (Ans. 4).
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Application 10/193,884

Enablement
Claims 16-23 stand rejected under 35 U.S.C. § 112, first paragraph,
“since the claimed invention is not supported by either a substantial or
specific asserted utility or a well established utility . . . one skilled in the art
clearly would not know how to use the claimed invention” (Ans. 5).
The Examiner bears the initial burden of showing that a claimed
invention is nonenabled. “[A] specification disclosure which contains a
teaching of the manner and process of making and using the invention in
terms which correspond in scope to those used in describing and defining the
subject matter sought to be patented must be taken as in compliance with the
enabling requirement of the first paragraph of § 112 unless there is reason to
doubt the objective truth of the statements contained therein which must be
relied on for enabling support.” In re Marzocchi, 439 F.2d 220, 223 (CCPA
1971). “[T]he PTO bears an initial burden of setting forth a reasonable
explanation as to why it believes that the scope of protection provided by
that claim is not adequately enabled by the description of the invention
provided in the specification of the application.” In re Wright, 999 F.2d
1557, 1561-62 (Fed. Cir. 1993).
As discussed above, the Examiner finds that the claimed system, or
“set of cell populations” (Ans. 9), “is for the production of . . . human
cardiomyocytes, from . . . human embryonic stem cells” (Ans. 4). The
Examiner does not question the ability of one skilled in the art to follow the
protocols disclosed in the Specification to generate human cardiomyocytes
from human embryonic stem cells (i.e., to “use” the system to generate
human cardiomyocytes). Nor does the Examiner question the ability of one
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skilled in the art to use “one or the other of the isolated cell populations to
screen compounds, or in therapeutic applications, such as reconstitution or
supplementation of contractile activity in cardiac tissue” (Ans. 6).
We find that the Examiner has not set forth a reasonable explanation
as to why the claims are not adequately enabled by the description of the
invention provided by the Specification. The rejection of claims 16-23
under 35 U.S.C. § 112, first paragraph, as lacking enablement, is reversed.
Anticipation
Claims 16-22 stand rejected under 35 U.S.C. § 102(a) as anticipated
by Thomson and Li, “as evidenced by K[h]amsi” (Roxanne Khamsi, Map of
DNA Differences Will Help Experts Tailor Drugs, news@nature.com,
published online October 26, 2005).
According to the Examiner, Thomson “teach[es] human embryonic
stem cell lines that are derived from human blastocysts” (Ans. 10), while Li
“teach[es] a homogeneous population of human cardiomyocytes (id.).
According to Li, the cardiomyocytes were isolated from human myocardial
biopsies (Li, Abstract).
The Examiner contends that “the cell populations [of the claimed
system] need not co-exist in the same place” (Ans. 9-10), “[t]hus . . . the
claimed set of two isolated cell populations encompasses two separate
products, both known in the art at the time of filing” (Ans. 10).
The Examiner concedes that “the claims recite . . . that the cell
populations are related” (Ans. 10), but contends that K[h]amsi “provide[s]
evidence that DNA between any two people is 99.9% similar . . . Thus, . . .
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DNA of any two human cells would be similarly identical” (id.), and “any
two human cells would be similarly related” (id.).
We disagree with the Examiner’s rationale and conclusion. The
claims do not merely require that the human cardiomyocyes and human
embryonic stem (hES) cells of the claimed system are “related,” in the sense
that all human cells are related. While the genetic complements of any two
people may typically be 99.9% similar (i.e., 0.1% dissimilar), according to
Khamsi, these “few tiny differences between their genetic codes account for
the way they vary in traits from eye color to susceptibility to disease.”
The present claims, on the other hand, require human cardiomyocytes
“differentiated” from the system’s human embryonic stem cells. We agree
with Appellant that “[t]he fact that the cardiomyocyte population is
differentiated from the hES cell population imposes structural limitations on
the cardiomyocyte population in that its chromosomal complement must be
derived from the hES cell population” (App. Br. 16). “[T]he two
populations are genetically related to one another in a very specific way”
(id.), and “share their chromosomal complement” (App. Br. 17). There is no
evidence that Li’s cells were derived (i.e., “differentiated”) from Thomson’s
cells, or that they otherwise share a chromosomal complement. Therefore,
we agree that “[t]his structural limitation of Appellant’s claims is missing
from Li et al.’s cardiomyocytes and Thomson’s hES cells” (App. Br. 16).
The rejection of claims 16-22 under 35 U.S.C. § 102(a) as anticipated
by Thomson and Li is reversed.
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Anticipation/Obviousness
Claims 16-22 stand rejected under 35 U.S.C. § 102(b), as anticipated
by, or under 35 U.S.C. § 103(a) as obvious over Li.
Again, Li describes primary cultures of cardiomyocytes isolated from
human myocardium (Li, Abstract), which the Examiner contends “would
have inherently been differentiated from human ES cells” (Ans. 11). The
Examiner contends “there is no temporal or spatial relationship between the
two cell populations” (id.), “[t]hus, Li et al. anticipate or make obvious the
claimed invention” (id.).
Nevertheless, the claims require a system comprising an isolated
population of human embryonic stem cells and an isolated cell population of
cardiomyocytes differentiated or descended from that population of human
embryonic stem cells. There is no evidence that the embryonic stem cells
from which Li’s cardiomyocytes were ultimately differentiated were ever
isolated. Moreover, there is nothing in Li to suggest isolating embryonic
stem cells.
Thus, we do not agree with the Examiner’s conclusion that Li
“anticipate[s] or make[s] obvious the claimed invention” (Ans. 11), and the
rejection of claims 16-22 under 35 U.S.C. § 102(b), as anticipated by, or
under 35 U.S.C. § 103(a) as obvious over Li is reversed.

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Application 10/193,884

SUMMARY
We reverse the rejections of the claims for lack of utility and lack of
enablement, because the instant application discloses a utility for the claimed
invention that meets the requirements of 35 U.S.C. §§ 101 and 112, first
paragraph. Finally, we reverse the rejections of the claims under 35 U.S.C.
§§ 102(a), 102(b), and 103(a).

REVERSED

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