Ex Parte Young et al

Patent Trial and Appeal Board

Jun 29, 2018

11574622 (P.T.A.B. Jun. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
111574,622
24392 7590
FISH IP LAW, LLP
2603 Main Street
Suite 1000
Irvine, CA 92614
FILING DATE FIRST NAMED INVENTOR
10/28/2008 Henry E. Young
07/03/2018
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
101353.0002US 7076
EXAMINER
WILSON, MICHAEL C
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
07 /03/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
rfish @fishiplaw.com
Patents@fishiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HENRY E. YOUNG and ASA BLACK
Appeal 2017-006731 1
Application 11/574,622
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to isolated stem
cells in combination with a liquid serum-free defined medium. The
Examiner rejected the claims as being directed to subject matter ineligible
for patenting.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner's
rejection of claims 1, 3-12, and 25-35, as being directed to a judicial
exception (i.e., a law of nature, a natural phenomenon, or an abstract
idea) without significantly more. Ans. 3-10.
1 The Real Party in Interest is Moraga Biotech Corporation. App. Br. 2.
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Application 11/574,622
Claims 1 and 25, the independent claims on appeal, illustrate the
appealed subject matter and read as follows:
1. An isolated stem cell in combination with a liquid medium,
compnsmg:
a viable at least pluripotent and purified post-natal stem
cell having a size of equal or less than 1 µm,
expressing surface marker CEA-CAM-I, and not
expressing surface markers SSEA-1, SSEA-3, and
SSEA-4, and wherein the viable post-natal stem
cell is further characterized by trypan-blue
staining;
wherein the liquid medium is a liquid serum-free
defined cell culture medium that is formulated to
allow in the absence of differentiation inhibitors
cultivation of the stem cell over more than 100
doublings without loss of normal karyotype while
preserving totipotent character,
wherein the stem cell is a mammalian cell having surface
marker CD66e and not CDIO;
wherein the stem cell expresses at least one of, Oct-3/4,
Nanog, Nanos, BMI-1, IDEI, IDE3, ABCG2,
CXCR-4, and BCL-2, and wherein the cell does
not express at least one of CDI a, CD2, CD3,
CD4, CDS, CD7, CDB, CD9, CDI 1 b, CDll c,
CD13, CD14, CD15, CD16, CD18, CD19, CD20,
CD22, CD23, CD24, CD25, CD31, CD33, CD34,
CD36, CD38, CD41, CD42b, CD45, CD49d,
CD55, CD56, CD57, CD59, CD61, CD62E,
CD65, CD68, CD69, CD71, CD79, CD83, CD90,
CD95, CD105, CD106, CDI 17, CD123, CD135,
CD166, Glycophorin-A, MHC-I, HLA-DRII,
FMC-7, Annexin-V, and LIN; and
wherein the stem cell expresses telomerase, and wherein
the cell does not express MHC-I.
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Application 11/574,622
25. A stem cell culture, comprising:
an isolated viable at least pluripotent and purified
post-natal stem cell having a size of equal or less
than 1 µm, expressing surface marker
CEA-CAM-I, and not expressing surface markers
SSEA-1, SSEA-3, and SSEA-4, and wherein the
viable post-natal stem cell is further characterized
by trypan-blue staining;
wherein the stem cell is disposed in a liquid serum-free
defined cell culture medium in the absence of
differentiation inhibitors that allows cultivation
of the stem cell over more than 100 doublings
without loss of normal karyotype while preserving
totipotent character, wherein the stem cell is a
mammalian cell having surface marker CD66e and
not CDIO;
wherein the stem cell expresses at least one of
telomerase, Oct-3/4, Nanog, Nanos, BMI-1, IDEI,
IDE3, ABCG2, CXCR-4, and BCL-2, and wherein
the cell does not express at least one of CDl a,
CD2, CD3, CD4, CDS, CD7, CDB, CD9, CDI 1 b,
CDll c, CD13, CD14, CD15, CD16, CD18,
CD19, CD20, CD22, CD23, CD24, CD25, CD31,
CD33, CD34, CD36, CD38, CD41, CD42b, CD45,
CD49d, CD55, CD56, CD57, CD59, CD61,
CD62E, CD65, CD68, CD69, CD71, CD79,
CD83, CD90, CD95, CD105, CD106, CDI 17,
CD123, CD135, CD166, Glycophorin-A, MHC-I,
HLA-DRII, FMC-7, Annexin-V, and LIN; and
wherein the stem cell expresses telomerase, and wherein
the cell does not express MHC-I.
Appeal Br. 37-38, 39--40 (emphasis added to show claim limitation at
issue).
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Application 11/574,622
STANDARD OF REVIEW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
DISCUSSION
The Examiner's Prima Facie Case
In concluding that claims 1, 3-12, and 25-35 recite subject matter
ineligible for patenting, the Examiner found that although the Specification
described the isolation and characterization of the stem cells recited in the
claims, the Specification nonetheless did not include any "discussion as to
markedly different characteristic differences between the stem cell once
isolated and the stem cell residing in its tissue counterpart." Ans. 8-9.
As to the culture medium recited in the claims, the Examiner asserted
that isolating stem cells, and their "subsequent culture in medium to prevent
differentiation and physical characteristics of the stem cells are each well-
understood, routine and conventional in field stem cell biology. All stem
cells isolated from tissue are routinely cultured such that remain pluripotent,
totipotent or multipotent and are routinely analyzed for physical
characteristics." Id. at 9.
Therefore, the Examiner concluded, the rejected claims "do not
provide any limitations indicating the claimed isolated stem cell in
combination with a liquid medium or a cell culture comprising the isolated
stem cells exhibits any characteristics or properties that are significantly
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Application 11/574,622
more than the judicial exception, the stem cell residing in its tissue source."
Id. at 9-10.
Analysis
35 U.S.C. § 101 states that "[w]hoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title."
The Supreme Court has "long held that this provision contains an
important implicit exception: Laws of nature, natural phenomena, and
abstract ideas are not patentable." Alice Corp. Pty. Ltd. v. CLS Bank Intern.,
134 S. Ct. 2347, 2354 (2014).
Our reviewing court has summarized the Supreme Court's two-part
test for distinguishing between claims to patent-ineligible exceptions, and
claims to patent-eligible applications of those exceptions, as follows:
Step one asks whether the claim is "directed to one of
[the] patent-ineligible concepts." [Alice, 134 S. Ct. at 2354]. If
the answer is no, the inquiry is over: the claim falls within the
ambit of § 101. If the answer is yes, the inquiry moves to step
two, which asks whether, considered both individually and as
an ordered combination, "the additional elements 'transform the
nature of the claim' into a patent-eligible application." Id.
(quoting Mayo [Collaborative Services v. Prometheus Labs,
Inc., 132 S. Ct. 1289, 1297 (2012)]).
Step two is described "as a search for an 'inventive
concept."' Id. (quoting Mayo, 132 S. Ct. at 1294). At step two,
more is required than "well-understood, routine, conventional
activity already engaged in by the scientific community," which
fails to transform the claim into "significantly more than a
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patent upon the" ineligible concept itself. Mayo, 132 S. Ct. at
1298, 1294.
Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed.
Cir. 2016) (paragraphing added).
In the present case, Appellants persuade us that the preponderance of
the evidence does not support the Examiner's conclusion that the rejected
claims recite subject matter ineligible for patenting. In particular, even if we
were to agree with the Examiner that the rejected claims are directed to a
natural phenomenon, i.e., stem cells, Appellants persuade us (see Appeal Br.
25-26; Reply Br. 20-21) that the Examiner has not shown sufficiently that
the additional features recited in the claims constitute well-understood,
routine, conventional activity already engaged in by skilled artisans in the
field of stem cell research.
As seen above, in addition to stem cells, both independent claims on
appeal recite compositions that also contain "a liquid serum-free defined cell
culture medium that is formulated to allow in the absence of differentiation
inhibitors cultivation of the stem cell over more than 100 doublings without
loss of normal karyotype while preserving totipotent character." Appeal Br.
37 (claim 1); see also id. at 39--40 (claim 25 reciting "a liquid serum-free
defined cell culture medium in the absence of differentiation inhibitors that
allows cultivation of the stem cell over more than 100 doublings without
loss of normal karyotype while preserving totipotent character").
In setting out the prima facie case, the Examiner asserts that culturing
stem cells "in medium to prevent differentiation ... [is] well-understood,
routine and conventional in field stem cell biology. All stem cells isolated
from tissue are routinely cultured such that remain pluripotent, totipotent or
multipotent and are routinely analyzed for physical characteristics." Ans. 9.
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In setting out the rejection, however, in addition to failing to acknowledge
the specific features of the recited culture medium, e.g., that the medium is
serum-free, the Examiner did not identify any specific evidence, in the
Specification or otherwise, to support the assertion that the culture medium
recited in claims 1 and 25 was merely a well-understood conventional
element routinely combined with stem cells. See id. at 3-20 (Examiner's
statement of the rejection).
In response to Appellants' arguments in that regard, the Examiner
cites the Jiang2 and Kim 3 references. Ans. 11-12 (citing Jiang 41, Kim
583).
We acknowledge Jiang' s disclosure of several cultures of "MAP Cs"
(multipotent adult progenitor cells) that produced more than 100 doublings
(Jiang 41) as Appellants' claims 1 and 2 5 require of the recited culture
medium. The Examiner, however, does not identify any specific disclosure
in Jiang demonstrating that the culture medium used to produce those
doublings was conventionally and/or routinely used with stem cells. Nor has
the Examiner identified any specific disclosure demonstrating that the
medium used to produce those doublings was serum-free, and did not
contain differentiation inhibitors, as required by Appellants' claims 1 and
25.
As to Kim, we acknowledge the use of a medium to culture stem cells,
but that medium contains "10% fetal bovine serum" (Kim 583), contrary to
2 Y euhua Jiang et al., Pluripotency of mesenchymal stem cells derived from
adult marrow, 418 NATURE 41--49 (2002).
3 Jiyoung Kim et al., Ex Vivo Characteristics of Human Amniotic
Membrane-Derived Stem Cells, 9 CLONING AND STEM CELL 581-594 (2007).
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the requirements of Appellants' claims 1 and 25. Thus, like Jiang, Kim fails
to support the Examiner's position that a serum-free medium meeting the
requirements of Appellants' claims 1 and 25 was merely a well-understood,
conventional element skilled artisans routinely combined with stem cells.
Accordingly, even if we were to agree with the Examiner that the
rejected claims involve a natural phenomenon, i.e., stem cells, we are not
persuaded that the Examiner has presented a sufficient evidentiary basis to
support the factual finding that the additional features recited in the claims,
i.e., the claimed culture medium having the recited elements, constitute well-
understood, routine, conventional activity already engaged in by skilled
artisans in the field of stem cell research. See Berkheimer v. HP Inc., 881
F.3d 1360, 1369 (Fed. Cir. 2018) ("Whether something is well-understood,
routine, and conventional to a skilled artisan at the time of the patent is a
factual determination.").
Because the Examiner, therefore, has not shown by a preponderance
of the evidence that the combination of features set forth in Appellants'
claims is merely a recitation of a natural phenomenon alongside nothing
more than well-understood, routine, and conventional elements already
engaged in by skilled artisans in the field, we must reverse the Examiner's
rejection.
SUMMARY
For the reasons discussed, we reverse the Examiner's rejection of
claims 1, 3-12, and 25-35, as being directed to a judicial exception (i.e., a
law of nature, a natural phenomenon, or an abstract idea) without
significantly more.
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REVERSED
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