Ex Parte Kyba et al

Board of Patent Appeals and Interferences

Feb 23, 2011

11404213 (B.P.A.I. Feb. 23, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL KYBA and MICHELINA IACOVINO
__________

Appeal 2010-009976
Application 11/404,213
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
platelet-producing bioreactor. The Patent Examiner rejected the claims on
the ground of obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
According to the Specification, “expression of HoxA2 and/or HoxB2
in hematopoietic stem cells promotes self-renewal and proliferation of the
stem cells and preferentially generates large numbers of megakaryocyte
progenitor cells to the exclusion of other lineages.” (Spec. 3, ¶ 18.) The
megakaryocyte progenitor cells “differentiate into megakaryocytes that
produce platelets.” (Id.) Claims 1-8 and 19-21 are on appeal.2 Claim 1
reads:
1. A platelet-producing bioreactor comprising a culture vessel containing
(a) hematopoietic stem cells (HSCs) stably genetically engineered to
express HoxA2 or HoxB2, and
(b) platelet-producing megakaryocyte progeny of the HSCs.

The Examiner rejected the claims as follows:
• claims 1, 4, 6, and 19-21 under 35 U.S.C. § 103(a) as unpatentable
over Largman,3 Manfredini,4 two NCBI accession numbers,5 and Gandhi;6
• claims 2 and 3 under 35 U.S.C. § 103(a) as unpatentable over
Largman, Manfredini, two NCBI accession numbers, Gandhi, and Lois;7

2 Claims 9-18 were withdrawn from consideration. (App. Br. 1.)
3 Corey Largman et al., US Patent No. 5,837,507, issued Nov. 17, 1998.
4 Rossella Manfredini et al., The Kinetic Status of Hematopoietic Stem Cell
Subpopulations Underlies a Differential Expression of Genes Involved in
Self-Renewal, Commitment, and Engraftment, 23 STEM CELLS 496-506
(2005).
5 NM_006735 10/8/03, and NM_131116.1, 21/21/03 [sic] (per Ans. 3).
6 Manish J. Gandhi et al., A novel strategy for generating platelet-like
fragments from megakaryocytic cell lines and human progenitor cells,
35 BLOOD CELLS, MOLECULES, AND DISEASES 70-73 (2005).
7 Carlos Lois et al., Germline Transmission and Tissue-Specific Expression
of Transgenes Delivered by Lentiviral Vectors, 295 SCIENCE 868-872
(2002).
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• claim 7 under 35 U.S.C. § 103(a) as unpatentable over Largman,
Manfredini, two NCBI accession numbers, Gandhi, and Banu;8
• claim 8 under 35 U.S.C. § 103(a) as unpatentable over Largman,
Manfredini, two NCBI accession numbers, Gandhi, and Bischof;9 and
• claims 1 and 4-6 under 35 U.S.C. § 103(a) as unpatentable over
Kyba,10 Manfredini, two NCBI accession numbers, and Ahmed11 or Gandhi.
OBVIOUSNESS
The Issues
The Examiner’s position is that Gandhi taught culture conditions to
produce platelet fragments, and that a person of ordinary skill in the art
would have been motivated to improve Gandhi’s CD34+ stem cell and
megakaryocyte HSC progeny by stably transfecting the cells with another
Hox gene. (Ans. 5-6.) In view of Largman and Manfredini’s teachings that
Hox genes supported cells’ capacity to undergo substantial self-renewal, the
Examiner concluded it would have been obvious to use Hox2 for the
purpose. (Id. at 4-5.) As Largman taught stem cell expansion and producing
megakaryocytes in culture, and as Gandhi taught producing megakaryocytes
in culture, the Examiner considered their culture vessels to be bioreactors.

8 Naheed Banu et al., Cytokine-Augmented Culture Of Haematopoietic
Progenitor Cells In A Novel Three-Dimensional Cell Growth Matrix,
13 CYTOKINE 349-358 (2001).
9 Daniel F. Bischof et al., US Patent No. 6,936,413 B1, issued Aug. 30,
2005.
10 Michael Kyba et al., HoxB4 Confers Definitive Lymphoid-Myeloid
Engraftment Potential on Embryonic Stem Cell and Yolk Sac Hematopoietic
Progenitors, 109 CELL 29-37 (2002).
11 N. Ahmed et al., Cytokine-Induced Expansion of Human CD34+
Stem/Progenitor and CD34+CD41+ Early Megakaryocytic Marrow Cells
Cultured on Normal Osteoblasts, 17 STEM CELLS 92-99 (1999).
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Appellants contend that Largman described a method of expanding
hematopoietic cells solely for transplantation, and that to be useful for
Largman’s transplantation purpose, the cells should not cause cancer. (App.
Br. 3.) According to Appellants, it was well-known that the ability to
increase self-renewal without being leukemogenic was specific to HoxB4
(id.), and they argue that “unequivocally,” this HoxB4 ability was “unique”
(id. at 5). Appellants dismiss Largman’s broader disclosures as “legalese”
and “draftsmanship” (id.) and argue that “[a] fair reading of Largman
teaches away from expression of any non-HoxB4 gene because HOXB4 was
demonstrably unique among Hox genes in its ability to increase the self-
renewal of hematopoietic stem cells without disrupting normal
differentiation (being leukemogenic)” (id. at 6). Appellants do not dispute
that Manfredini taught Hox2 was associated with self-renewal, but argue that
being involved in self-renewal does not make a gene a candidate for
Largman’s methods, which, according to Appellants, “require transplantable,
non-leukemogenic cells.” (Id. at 6.) Appellants contend that Gandhi’s
disclosure “has no discernable relevance to the claimed invention, or
combinability with any of the cited art.” (Id. at 6.)
The issues with respect to the rejections over Largman with other
references are:
did Largman teach that expanded hematopoietic cells could be used
only for transplantation;
did Appellants provide evidence to support their contention that
HoxB4 was considered unique in its ability to increase self-renewal without
causing leukemia;
is Gandhi’s disclosure relevant to the claimed invention;
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did the Examiner reasonably combine Gandhi’s teachings with the
other art; and
does the evidence support the Examiner’s conclusion that there was a
reasonable expectation that the bioreactor suggested by the references would
produce platelets?
Findings of Fact
We adopt the Examiner’s findings concerning the scope and content
of the prior art. For reference purposes in the Analysis below, we list some
of the Examiner’s citations by number:
1. Largman taught a “stem cell modified to express an exogenous HOX
gene.” (Largman, col. 2, ll. 35-44.) According to Largman, “[w]hen
the modified stem cell is a hematopoietic stem cell, the expanded
population of stem cells is characterized by the capacity to undergo
substantial self-renewal and the ability to give rise to all
hematopoietic cell lineages.” (Id.)
2. Largman taught:
In a preferred embodiment, the stem cell is a hematopoietic
stem cell. In a more specific embodiment, the hematopoietic
stem cell is a human hematopoietic stem cell expressing the
surface marker CD34.

(Id. at col. 2, ll. 49-52.)
3. Largman taught:
The HOX gene useful in the invention is any HOX gene which
results in enhancement of stem cell capacity to undergo
substantial self-renewal and the ability to give rise to all
hematopoietic cell lineages. Preferably the HOX gene inserted
into the stem cell of the invention is a member of the HOXA or
HOXB clusters; more preferably, the gene is HOXB4. . . .
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The expanded population gives rise to mature blood cells in the
same or similar proportions resulting from the expansion of
nonmodified stem cells. Still further, when transplanted into a
recipient subject, the expanded population of stem cells restore
hematopoietic capability to a subject without the development
of leukemia.

(Id. at col. 2, l. 53 - col. 3, l. 9)
4. Largman taught:
When in vitro expansion is desired, a combination of various
cytokines can be utilized to ensure that the transduced cell
population will include expanded numbers of progenitor cells
and more mature cells of the various hematopoietic lineages
(e.g., megakaryocytes, neutrophils) in addition to stem cells to
provide a cell population that will provide both short-term and
long-term repopulation potential.

(Id. at col. 12, ll. 30-37.)
5. Manfredini disclosed that
[a]nalysis of [transcription factor] expression indicated that
most cells involved in self-renewal process were upregulated in
CD34+ cells (Fig.5A). Among them, HOXA5, HOXA9,
HOXA10, HOXB2, HOXB5, Meis1, and PBX2 are preferentially
expressed by CD34+ cells.

(Manfredini 502.)
6. Gandhi stated that “[t]ransfusion of allogeneic platelets is the
mainstay of therapy for patients with thrombocytopenic hemorrhage.”
(Gandhi, Abstract.)
7. Gandhi reported that
[a]lthough we can isolate PFs [platelet fragments] from UT-
7/TPO cells with aggregation properties similar to platelets,
electron microscopy reveals that these fragments do not have
the usual structure of normal platelets . . . .
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(Id. at 73.)
8. Gandhi reported that
[t]he PFs released by these cells aggregate like platelets, raising
the possibility that thrombocytes may be produced in vitro in
the future. Much work remains to make this a practical goal,
such as expanding precursor hematopoietic cells without losing
capacity for differentiation.

(Id.)
9. The Examiner found that NM_006735 and NM_131116.1 provided
the nucleotide sequence for HoxA2 and HoxB2, respectively. (Ans.
5.)
10. Lois taught how to use lentiviral vectors to deliver transgenes to cells
for tissue specific expression. (Lois 869.)
11. Banu taught how to use insoluble three-dimensional structures for
hematopoietic stem cell expansion. (Banu 355.)
12. Bischof evidenced that apheresis devices for collecting platelets from
blood were well known before Appellants’ invention. (Bischof, col.
2, ll. 6-28.)
13. Ahmed disclosed that thrombocytopenia was a significant cause of
morbidity in cancer patients, requiring extensive expenditures for
frequent platelet transfusions. (Ahmed 92.)
14. Ahmed described a system for culturing CD34+ cells and expanding
megakaryocyte progenitor cells to accelerate platelet recovery. (Id. at
95-96.)
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Principles of Law
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006). Reasoning to modify a known apparatus may be based
on problems known in the art. E.g., Princeton Biochemicals, Inc. v.
Beckman Coulter, Inc., 411 F.3d 1332, 1338-1339 (Fed. Cir. 2005)
(affirming obviousness where motivation was found in the knowledge of
those skilled in the art at the time, and where the nature of the problem also
supplied a motivation). “In other words, the nature of the problem called for
exactly the solutions in the prior art.” Id. at 1339. Accord, DyStar
Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d
1356, 1366 (Fed. Cir. 2006) (“the ‘evidence’ of motive will likely consist of
an explanation of the well-known principle or problem-solving strategy to
be applied”).
“Obviousness does not require absolute predictability of success. . . .
[A]ll that is required is a reasonable expectation of success.” In re
O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). The disclosure in a patent
is presumed enabled. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314
F.3d 1313, 1355 (Fed. Cir. 2003).
A prior art reference is said to teach away from an Applicant’s
invention “when a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “The prior art’s
mere disclosure of more than one alternative does not constitute a teaching
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away from any of these alternatives because such disclosure does not
criticize, discredit, or otherwise discourage the solution claimed.” In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
“[O]bviousness must be determined in light of all the facts, and there
is no rule that a single reference that teaches away will mandate a finding of
nonobviousness. Likewise, a given course of action often has simultaneous
advantages and disadvantages, and this does not necessarily obviate
motivation to combine. See [Winner Int'l Royalty Corp. v. Wang, 202 F.3d
1340,] 1349 n. 8 [(Fed.Cir.2000)] (“The fact that the motivating benefit
comes at the expense of another benefit, however, should not nullify its use
as a basis to modify the disclosure of one reference with the teachings of
another. Instead, the benefits, both lost and gained, should be weighed
against one another.”). Where the prior art contains “apparently conflicting”
teachings (i.e., where some references teach the combination and others
teach away from it) each reference must be considered “for its power to
suggest solutions to an artisan of ordinary skill.... consider[ing] the degree to
which one reference might accurately discredit another.” In re Young, 927
F.2d 588, 591 (Fed.Cir.1991). Medichem, S.A. v. Rolabo, S.A., 437 F.3d
1157, 1165 (Fed. Cir. 2006).
“[I]t is well settled that unexpected results must be established by
factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).

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Analysis
I. Rejections over Largman, Manfredini, two NCBI accession numbers,
and Gandhi et al.
Claims 1, 4, and 6
We agree with the Examiner that Gandhi addressed the same problem
that Appellants’ bioreactor addresses: the need for platelets. (FF6.) Gandhi
explicitly criticized its own results and explicitly taught that more work was
needed. (FF7, 8.) Thus, Gandhi motivated those in the art to work on this
problem. Ahmed’s disclosure is similar. (FF13, 14.) Largman and
Manfredini, taken with Gandhi, demonstrate that solutions to the platelet
problem were in the prior art, as explained in the rejection. See Princeton
Biochemicals, 411 F.3d at 1339; DyStar, 464 F.3d at 1366. We therefore
affirm the rejection.
Appellants’ criticisms of the Largman disclosure are unpersuasive.
Largman explicitly taught using any Hox gene. (FF3.) Largman explicitly
taught using the Hox genes to drive hematopoietic cell expansion for the
purpose of producing all hematopoietic cell lineages including
megakaryocytes. (FF4.) Although Appellants contend there is no
relationship between Largman and Gandhi, we note that Largman explicitly
stated that differentiated cells such as platelets may be removed (see
Largman, col. 6, ll. 43-49), and we find Appellants’ contention unsupported
by evidence. Appellants claim that Hox4 “was demonstrably unique among
Hox genes” in not being leukemogenic, but do not support their argument
with evidence pertinent to Hox2. (App. Br. 6.) To show that Largman’s
disclosure was not enabling for the purpose of producing megakaryocytes,
one must do more than dismiss the facts disclosed as mere draftsmanship.
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(Id. at 5; Reply Br. 3.) The Largman inventors signed a declaration under
37 C.F.R. § 1.63 stating that they had reviewed and understood the contents
of their application, and we therefore find Appellants’ contentions about
draftsmanship unpersuasive. The disclosure in a patent is presumed enabled.
Amgen, 314 F.3d at 1355. To the extent that inducing leukemia was a
concern, all the facts in evidence must be considered. Medichem, 437 F.3d
at 1165. Here, Appellants have not shown persuasive evidence supporting
their contention that a person of ordinary skill in the art would have avoided
using Hox2. We find the references were properly combined and conclude
they rendered the claimed bioreactor obvious.
We also agree with the Examiner that the evidence supports
concluding that there would have been a reasonable expectation of success
in producing a bioreactor functioning at the level required by the claims.
Although Appellants dispute the expectation, their argument is only
conclusory. See Geisler, 116 F.3d at 1470.
We agree with Appellants that some of the Examiner’s statements
concerning claim interpretation were inconsistent. The Reply Brief alleges
“the rejections are dependent on a strawman claim construction that our
claims ‘do not even require production of platelets’ (e.g. Answer, p.13, lines
15-16).” (Reply Br. 1). We agree with Appellants that the claims define a
“platelet-producing” bioreactor. Notwithstanding the Examiner’s statements
in the “Response to Argument” section of the Answer, however, the actual
statements of rejection explained why and how a bioreactor producing
platelets would have been obvious. Because the rejections demonstrated that
the platelet-producing bioreactor producing platelets at the levels claimed
would have been obvious, we are not persuaded that the errant statement in
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the “Response to Argument” section of the Answer is a ground for reversal.
Appellants also contend that the Examiner’s statement “expression of
hox gene is not required in the platelet producing megakaryocyte progeny”
(Ans. 3) was wrong. It appears that the statement was directed to claims 1-8,
19, and 20, none of which explicitly require Hox2 expression in the
megakaryocyte progeny, in contrast to claim 21, which further limits claim 1
with the phrase “the megakaryocyte progeny express the HoxA2 or HoxB2.”
The rejections were directed to the limitations of the claims, properly
interpreted. See Ans. 5 (“[i]t would have been obvious for one of ordinary
skill to stably express the genes from Hox-B2 or its paralog to promote self
renewal and proliferation of HSC”.) Appellants had notice of the
explanation and the evidence relied upon. Put another way, the rejections
established that the prior art “contained detailed enabling methodology for
practicing the claimed invention, a suggestion to modify the prior art to
practice the claimed invention, and evidence suggesting that it would be
successful.” O’Farrell, 853 F.2d at 902.
Claims 4 and 6 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
Claim 19
Claim 19 further limits the bioreactor of claim 1 to containing a
culture medium supplemented with thrombopoietin (TPO). The Examiner
found that Largman and Gandhi “indicated that one could achieve optimal
expansion of platelet producing megakaryocytes from human marrow
CD34+ cells in culture grown in the presence of [a] combination of
cytokines that included TPO.” (Ans. 5.)
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Appellants dispute that the prior art suggested a bioreactor containing
culture medium supplemented with thromobopoietin (TPO). (App. Br. 7.)
This argument is unpersuasive because it is inconsistent with the evidence in
the rejection.
Claims 20 and 21
Claim 20 further limits the bioreactor of claim 1 to one that “generates
platelets suitable and sufficient for repeated transfusion,” and “preferentially
generates large numbers of megakaryocyte progenitor cells to the exclusion
of other lineages.” Claim 21 further limits the bioreactor of claim 1 to
performing as in claim 20, and in addition, by requiring that “the
megakaryocyte progeny express the HoxA2 or HoxB2.” The Examiner
concluded there would have been a reasonable expectation of success in
improving the prior art platelet production systems. (Ans. 5-6.)
Appellants dispute that the prior art suggested “such a particularly
operable and functional device.” (App. Br. 7.) The Examiner responded
that Appellants have not made a showing of unexpected results (Ans. 16-17),
and that the evidence supports the rejection (id. at 17-18). We agree with
the Examiner that the evidence supports a reasonable expectation that the
bioreactor suggested by the references would have performed as recited in
claims 20 and 21, and find Appellants’ arguments unpersuasive because the
evidence in the rejection supports the Examiner’s conclusion.
II. Claims 2 and 3
Claims 2 and 3 further limit the HSCs of claim 1 to those “engineered
with a self-inactivating lentiviral vector that expresses a HoxA2 transgene”
(claim 2) or “a HoxB2 transgene” (claim 3). In addition to the evidence
relied on to reject claim 1, the Examiner relied on Lois for its teachings
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concerning self-inactivating lentiviral vectors to deliver genes for expression
in cells. (Ans. 7.)
Appellants contend that Lois “does not anywhere suggest any
application or relevance to the field of the present invention.” (App. Br. 8.)
We find that argument unpersuasive because the evidence supports finding
that Lois’s teachings concerning self-inactivating lentiviral vectors are
pertinent to the self-inactivating lentiviral vectors named in claims 2 and 3.
(FF10.) We affirm the rejection for the reasons given by the Examiner.
III. Claim 7
Claim 7 further limits the bioreactor of claim 1 to “comprising an
insoluble matrix which retains the HSCs.” In addition to the evidence relied
on to reject claim 1, the Examiner relied on Banu for its teachings
concerning an insoluble three-dimensional matrix for long-term culture of
HSCs. (Ans. 8.)
Appellants contend that “[t]his reference neither teaches nor suggests
anything about our method of overexpressing HoxA2 or B2 in order to
obtain platelet-producing megakaryocyte progeny.” (App. Br. 9.) We find
that argument unpersuasive because the other references suggested the
bioreactor of claim 1 (which does not require “overexpressing” any genes),
and Banu disclosed culturing HSCs in an insoluble 3-dimensional matrix.
(FF11.) We affirm this rejection for the reasons given by the Examiner.
IV. Claim 8
Claim 8 further limits the bioreactor of claim 1 to being “in fluid
connection with an apheresis device operative to selectively remove platelets
from the bioreactor.” In addition to the evidence relied on to reject claim 1,
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the Examiner relied on Bischof for its teachings concerning a known
apheresis device routinely used in the art to separate platelets. (Ans. 9.)
Appellants contend “[t]his cited art does not support the proffered
rejection of claim 8 anymore than it does the invention of claims 1 and 4.”
(App. Br. 9.) We find that argument unpersuasive because the other
references suggested the bioreactor of claims 1 or 4, and Bischof taught
known apheresis devices for collecting platelets. (FF12.) We affirm this
rejection for the reasons given by the Examiner.
V. Rejection of claims 1 and 4-6 over Kyba, Manfredini, NCBI accession
numbers, and Ahmed or Gandhi.
The rejection states that Kyba described using a HoxB4 transgene in
ES cells to overcome the potential problem of constitutive retroviral
expression having undesirable effects on hematopoietic differentiation.
(Ans. 10.) According to the rejection, Kyba’s disclosure differed from the
claimed invention by not explicitly providing motivation for using hoxB2 or
its ortholog. (Id.) The rejection found that Manfredini reported that several
hox family genes including Hox2 were involved in the self renewal process,
but that Manfredini differed from the claimed invention by not disclosing
transfection of HSC with HoxA2 or HoxB2. (Id. at 10-11.) The rejection
then found that Ahmed taught BM (bone marrow) CD34+ cells for ex vivo
expansion of both CD34+CD41+ early and CD41+ late megakaryocytic cells.
(Id. at 11.) In view of those teachings, the rejection concluded that
Appellants’ claimed bioreactor would have been obvious. We disagree.
We find the rejection insufficient to establish a prima facie case of
obviousness because it did not explain why a person of ordinary skill in the
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art would have related the Kyba, Manfredini, and Ahmed disclosures in the
manner suggested.
SUMMARY
We affirm the rejection of claims 1, 4, 6, and 19-21 under 35 U.S.C.
§ 103(a) as unpatentable over Largman, Manfredini, two NCBI accession
numbers, and Gandhi.
We affirm the rejection of claims 2 and 3 under 35 U.S.C. § 103(a) as
unpatentable over Largman, Manfredini, two NCBI accession numbers,
Gandhi, and Lois.
We affirm the rejection of claim 7 under 35 U.S.C. § 103(a) as
unpatentable over Largman, Manfredini, two NCBI accession numbers,
Gandhi, and Banu.
We affirm the rejection of claim 8 under 35 U.S.C. § 103(a) as
unpatentable over Largman, Manfredini, two NCBI accession numbers,
Gandhi, and Bischof.
We reverse the rejection of claims 1 and 4-6 under 35 U.S.C. § 103(a)
as unpatentable over Kyba, Manfredini, two NCBI accession numbers, and
Ahmed or Gandhi.
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-IN-PART

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