Ex Parte Woda et al

Patent Trial and Appeal Board

Sep 4, 2018

14189474 (P.T.A.B. Sep. 4, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/189,474 02/25/2014 Juliana Megan Woda
26294 7590 09/06/2018
TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300EASTNINTH STREET, SUITE 1700
CLEVELAND, OH 44114
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.
ATY-0008US-DIV 1585
EXAMINER
VISONE, THOMAS J
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
09/06/2018 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):
rkline@tarolli.com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED ST ATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JULIANA MEGAN WODA, ANTHONY E. TING,
and NICHOLAS A. LEHMAN 1
Appeal 2017-009395
Application 14/189,474
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREYN. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is ABT Holding Company.
App. Br. 3.
Appeal 2017-009395
Application 14/189,474
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 16-27, which stand rejected as
unpatentableunder 35 U.S.C. § 103(a) as being obvious over the
combination of Verfaillie et al. (US 2006/0008450 Al, January 12, 2006)
("Verfaillie"), Banfi et al. (WO 2007 /132012 Al, November 22, 2007)
("Banfi"), andR.M. Strieter et al., Cancer CXC ChemokineNetworks and
Tumour Angiogenesis, 42 EURO. J. CANCER 768-78 (2006) ("Strieter").
We have jurisdiction under35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to methods for treating pathological
conditions that can be improved by providing angiogenesis by administering
cells that express and/or secrete one or more pro-angiogenic factors.
Abstract.
REPRESENT AT IVE CLAIM
Claim 16 is representative of the claims on appeal and recites:
16. A method for constructing a cell bank, said method
comprising expanding and storing cells that have a desired
potency for expression and/or secretion of the pro-angiogenic
factors VEGF, CXCL5 and IL-8 for future administration to a
subject, the cells being non-embryonic stem, nongerm cells that
express one or more of oct4, telomerase, rex-1, or rox-1 and/or
can differentiate into cell types of at least two of endodermal,
ectodermal, and mesodermal germ layers, wherein the cells are
assayed for having the desired potency by means of an assay
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consisting essentially of assaying expression and/or secretion of
VEGF, CXCL5, andIL-8.
App. Br. 24.
ISSUES AND ANALYSES
We adopt the Examiner's findings of fact and conclusion that the
appealed claims are obvious over the combined prior art cited by the
Examiner. We address the arguments raised by Appellants below.
Issue 1
Appellants argue that the Examiner erred in fmding that the
transitional phrase "consisting essentially of' can be construed in this claim
as meaning the transitional phrase "comprising." App. Br. 12.
Analysis
The Examiner fmds that Appellants' claims and Specification fail to
provide a clear indication of what constitutes the basic and novel
characteristics of their claimed invention. Final Act. 4. The Examiner fmds
that, whereas Appellants' Specification has provided a defmition for the
term "comprising," it does not provide a defmition of what is encompassed
by the term "consisting essentially of." Id. ( citing Spec. ,r,r 69-70). The
Examiner therefore interprets the transitional phrase "consisting essentially
of' to mean "comprising." Id.
Appellants argue that both the claims and their Specification provide a
clear indication of what constitute the basic and novel characteristics of the
claimed invention and, as such, show what the essential features are. App.
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Br. 14. According to Appellants, each of the independent claims recites a
method consisting essentially of assaying immune cells for the secretion of
pro-angiogenic factors VEGF, CXCL5, andIL-8. Id.
Appellants assert that it is also evident from the Specification that an
assay for the specific combinationofVEGF, CXCL5, andIL-8 is necessary
and sufficient to indicate the angiogenic potential of the recited cells. App.
Br. 14. Appellants point to paragraph 170 of the Specification, which
discloses, in relevant part: "The inventors identified multiple pro-
angiogenic factors secreted by MultiStem including VEGF, CXCL5, andIL-
8 and found all three factors are necessary for MultiStem[-]induced
angiogenesis." Appellants also point to paragraph 177, which discloses:
"Multiple pro-angiogenic factors secreted by MultiStem were identified
including VEGF, CXCL5 andIL-8; andimmunodepletion studies
demonstrated that all three factors are necessary for MultiStem[-]induced
angiogenesis." Appellants therefore contend that the basic and novel
characteristics of the claimed invention are clear from the claims and the
Specification of the present application. Id.
The Examiner responds that the case law of our reviewing court, as
well as MPEP § 2111. 03, requires that, absent a clear indication in the
Specification or claims of what the basic and novel characteristic actually
are, "consisting essentially of' should be construed as equivalent to
"comprising." Ans. 12-14 (citing, e.g., PPG Indus. v. Guardian Indus.
Corp., 156F.3d 1351 (Fed. Cir. 1998);AK Steel Corp, v. Sollac and Ugine,
344 F.3d 1234 (Fed. Cir. 2003); In re Bhogaraju v. Janakirama-Rao, 317
F.2d951 (C.C.P.A. 1963)). TheExaminerfmds Appellants have failed to
offer any clear indication in either the claims or the Specification of what
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Application 14/189,474
actually constitutes the basic and novel characteristics of claimed method
and, as such, the transitional phrase "consisting essentially of' was
appropriately construed as being equivalent to the transitional term
"comprising." Id.
We are not persuaded by Appellants' arguments. The Federal Circuit
has held that the transitional phrase "consisting essentially of' typically:
[P]recedes a list of ingredients in a composition claim or a series
of steps in a process claim. By using the term "consisting
essentially of," the drafter signals that the invention necessarily
includes the listed ingredients and is open to unlisted ingredients
that do not materially affect the basic and novel properties of the
invention. A "consisting essentially of' claim occupies a middle
ground between closed claims that are written in a "consisting
of' format and fully open claims that are drafted in a
"comprising" format.
PPG, 156F.3dat 1354.
The disputed limitation of claim 16 recites: "wherein the cells are
assayed for having the desired potency by means of an assay consisting
essentially of assaying expression and/or secretion of VEGF, CXCL5, and
IL-8." (Emphasis added). In other words, the claim recites that assays for
secretion ofVEGF, CXCL5 and IL-8 are required to be performed by those
practicing the claimed method, but also that other assays may be performed
insofar as they do not materially affect the basic and novel characteristics of
Appellants' claimed invention.
Appellants contend that the novel and basic characteristic of their
claimed invention is that the three pro-angiogenic factors recited in the claim
are "necessary and sufficient" for angiogenesis. See App. Br. 14. Based
upon the passages of the Specification cited by the Examiner, and the
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remaining disclosures of the Specification, we agree with Appellants'
assertion that the Specification discloses that the three factors are necessary
for angiogenesis.
However, reading Appellants' claim, in view of the disclosures of the
Specification, we interpret the scope of the claim to embrace, inter alia,
administering non-embryonic stem, non-germ cells that have been assayed
for the secretion ofVEGF, CXCL5, and IL-8 Consequently, we construe the
transitional claim phrase "consisting essentially of," as consisting of the
assays for VEGF, CXCL5, and IL-8 and also including any other assay or
procedure that does not impede, or otherwise materially affect, the
performance of the three cytokine assays recited expressly in the claim and
in determining the cells desired potency.
Issue 2
Appellants argue the Examiner erred because there is no guidance in
the cited prior art that would have motivated the skilled artisan to assay for
the specific combinationofpro-angiogenesis factors. App. Br. 18.
Analysis
The Examiner finds that Banfi teaches a method similar to that of
Verfaillie and Appellants' claims in which "a discrete threshold in VEGF
dosage exists, below which normal stable capillaries are induced and above
which angioma growth occurs." Final Act. 5 ( citing Banfi 1 ). The
Examiner fmds the teachings of Banfi would have motivated a person of
ordinary skill in the art to use routine laboratory techniques known at the
time of invention to determine whether VEGF is secreted by MAP Cs and to
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ensure VEFG levels optimally promoted angiogenesis while avoiding
complications such as angiomas. Id.
The Examiner also finds Strieter teaches that VEGF, CXCL5, and IL-
8, are well-known in the art as potent promoters of angiogenesis. Final Act.
6 (citing Strieter 768-769; Table 1). The Examiner therefore fmds that a
person of ordinary skill in the art would be motivated by Strieter to assay for
the secretion and validate the potency of these factors in the MAPCs of
Verfaillie to advantageously optimize the therapeutic efficacy of the method
taught by Verfaillie. Id.
Appellants dispute the Examiner's fmding that Banfi and Strieter
provide guidance to assay cells for secretion of the recited combination of
factors (VEGF, CXCL5, andIL-8). App. Br. 18. Appellants argue that
neither Banfi nor Strieter teach the specific combination of factors. Id.
Rather, Appellants assert, Banfiaddresses only VEGF, whereas Strieter
merely lists ten angiogenic factors from which up to a thousand
permutations of factor combinations are possible. Id. According to
Appellants, Strieter provides no guidance or teaching that would lead one in
the direction of the specific claimed combination. Id. Therefore, Appellants
argue, neither Banfi nor Strieter, alone or combined, would have motivated a
person of ordinary skill in the art to combine the essential components of the
assay to these three factors. Id.
Appellants contend that the passages of Verfaillie relied upon by the
Examiner present different possible mechanisms of action by which
multipotent adult progenitor cells ("MAP Cs") may contribute to new tissue.
App. Br. 19 (citing, e.g., Verfaillie ,r 76).
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Appellants contend that, if a person of ordinary skill in the art had
been motivated to testthe pro-angiogenic potential ofMAPCs, it would have
been essential to assay all of Strieter' s pro-angiogenic factors, and not just
the specific claimed combination. App. Br. 19. Appellants assert that all of
Strieter's factors would have been essential to the claimed assay because, at
the time of the claimed invention, each factor and combination of factors
would have been equally important in an assay to assess pro-angiogenic
potential. Given this, and the fact that there are over a thousand possible
combinations of Strieter' s pro-angiogenic factors, there would have been no
reason that would have motivated the person of skill to narrow an assay to
VEGF, CXCL5, andIL-8 as the essential pro-angiogenic factors. Id.
The Examiner responds that the claims on appeal are not limited to
assaying only for VEGF, CXCL5, andIL-8 secretion, but, rather, encompass
assaying for the secretion ofVEGF, CXCL5, andIL-8 as well as any
additional pro-angiogenic factors. Ans. 14. The Examiner states that
Appellants are therefore attempting to improperly impart a preferred, narrow
embodiments from their Specification into the more broadly-worded claims.
Id. at 14--15. The Examiner fmds the prior art of record sets forth an explicit
motivation to assay for VEGF, CXCL5, andIL-8 secretion as well as the
secretion of other pro-angiogenic factors. Id. at 15.
We agree with the Examiner. Banfi teaches that it was known in the
art that: "Vascular Endothelial Growth Factor (VEGF) is an attractive
candidate being investigated to achieve therapeutic angiogenesis in ischemic
diseases." Banfi 1. Strieter teaches: "The angiogenic CXC chemokine
family members include CXCLl, CXCL2, CXCL3, CXCL5, CXCL6,
CXCL 7 and CXCL8 [i.e., IL-8] (Table 1). The angiogenic CXC
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chemokines interacting alone or with other angiogenic factors can function
in a direct, parallel, or serial manner to promote angiogenesis." Strieter 769.
We agree with the Examiner's conclusion that a person of ordinary skill
would be motivated to assay for all of these pro-angiogenic factors when
contemplating the administration of MAP Cs to promote angiogenesis, e.g.,
in view of Verfaillie' s teaching of the significance of secretion of cytokines
and other factors in the therapeutic efficacy of MAP Cs and the mentioned
teachings ofBanfi and Strieter.
We also agree with the Examiner's conclusion that the language of
Appellants' claims are not limited to assaying for the three pro-angiogenic
factors recited in the claims. Appellants' Specification has shown that these
three factors are necessary to promote angiogenesis. See Spec. ,r,r 170, 177.
However, even were we to adopt Appellants' preferred claim language that
the assays "consist essentially of' assaying for secretion ofVEGF, CXCL5
and IL-8 (see discussion, supra), Appellants have not provided us with any
evidence that assaying for any ( or all) of the other pro-angiogenic factors
taught by Strieter would somehow affect the novel and basic characteristics
of Appellants' claimed invention, e.g., identifying cells having the claimed
desired potency. Simply put, we do not see how conducting any additional
assays in addition to those recited would affect Appellants' claimed
invention, nor do Appellants enlighten us in this respect. We consequently
agree with the Examiner's conclusion that a person of ordinary skill would
have been motivated to combine the references to arrive at Appellants'
claimed invention.
Issue 3
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Appellants argue the Examiner erred because none of the references
teach or suggest that MAP Cs are being used to promote angiogenesis. App.
Br. 19.
Analysis
Appellants contend that the passages of Verfaillie relied upon by the
Examiner present different possible mechanisms of action by which
multipotent adult progenitor cells ("MAP Cs") may contribute to new tissue.
App. Br. 21 (citing, e.g., Verfaillie ,r 76, 44). However, Appellants argue,
the passages relied upon by the Examiner do not teach that MAP Cs provide
angiogenesis. Id. Rather, contend Appellants, paragraph [0076] presents
different possible mechanisms of action by which MAP Cs may contribute to
new tissue. Id. According to Appellants, this is insufficient to support the
Examiner's conclusion that "the MAPCs taught by Verfaillie promote
angiogenesis." Id. Furthermore, Appellants assert, paragraph [0044], is
similarly speculative and discusses various possible mechanisms of action
by which MAP Cs may contribute to new tissue.
We are not persuaded by Appellants' argument. The test of
obviousness is: "whatthe combined teachings of the references would have
suggested to those of ordinary skill in the art." In re Keller, 642 F.2d413,
425 (C.C.P.A. 1981). Verfaillie expressly teaches, inter alia:
MAPCs, as well as damaged cardiac tissues, secrete cytokines
that have beneficial effects, including recruitment of reparative
cells (e.g., MAPCs, hematopoietic, mesenchymal stem cells) to
the damaged tissue by "homing" mechanisms and modulation of
inflammatory processes. Homing of cells that can
advantageously repair myocardium, such as MAPCs, can be
preferentially induced by co-administration of cytokines.
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MAPCs can also promote angiogenesis, which further enhances
tissue repair.
Verfaillie ,r 191. Verfaillie also teaches:
Administered MAPCs may contribute to generation of new
tissue by differentiating into specific cells, such as
cardiomyocytes, in vivo .... Additionally, MAPCs may also
provide benefit by increasing capillary density and stimulating
angiogenesis. This may be achieved by production of angiogenic
factors, such as VEGF, or by differentiation of the MAP Cs and
inclusion in new vessel tissue, or both.
Verfaillie ,r 76 ( emphasis added). Finally, Verfaillie also teaches: "MAP Cs
expressedmRNAfor the cytokinesBMP 1, BMP5, VEGF, HGF,KGF,
MCPl; the cytokinereceptors Flkl, EGF-R, PDGF-Rla, gp130, LIF-R,
activing-Rl and -R2, TGFR-2, BMP-RlA; the adhesion receptors
CD49c, CD49d, CD29; and CDlO." Verfaillie ,r 124 (emphasis added).
VEGF (vascular endothelial growth factor) is well known in the art as a
factor promoting cellular differentiation. Id. ,r 87.
We therefore agree with the Examiner that the teachings of Verfaillie
would have been pri ma f aci e sufficient to suggest to a person of ordinary
skill in the art that administration ofMAPCs would be effective for the
promotion of angiogenesis and the treatment of various cardiac disorders by
repairing myocardium.
Issue4
Appellants argue the Examiner erred because the fact that the MAP Cs
Verfaillie express the three factors was not known, so that even if the
MAPCs express VEGF, CXCL5, andIL-8, that fact is irrelevant to whether
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a person of ordinary skill in the art would have been motivated to assay the
cells for those three factors. App. Br. 21.
Analysis
Appellants argue that: ( 1) as argued supra, Verfaillie does not teach
that MAP Cs provide angiogenesis, so a person of ordinary skill would not
have concluded that the MAP Cs must inherently secrete the three pro-
angiogenic factors: VEGF, CXCL5, andIL-8; and (2)the fact that the
Appellants' Specification discloses that VEGF, IL-8, and CXCL5 are
required for angiogenesis is irrelevant because the Examiner cannot apply
the Appellants' Specification as prior art. App. Br. 22. Appellants point out
that the discovery that these three factors are required for angiogenesis was
in fact the Appellants' discovery. Id.
Appellants therefore contend that even if the MAP Cs of Verfaillie do
express the three factors, the Examiner has not explained, and Appellants do
not see, how that would be relevant to motivate the person of ordinary skill
in the art to combine the cited references and arrive at the claimed invention.
Appellants assert that they claim an assay that has essential steps that were
not suggested by any of the prior art, either alone or in combination. Id.
The Examiner responds that Verfaillie teaches the use of multipotent
adult progenitor cells (MAP Cs). Ans. 18. The Examiner fmds that
Verfaillie further teaches MAPCs can be isolated from bone marrow, as is
similarly disclosed by Appellants' Specification. Id. ( citing Verfaillie 29,
112-113; Spec. ,r,r 75-77, 117). The Examiner fmds thatthe only cell type
disclosed and exemplified by Appellants' Specification is MAPCs. Id. at
18-19. The Examiner therefore reasons that MultiStem® is the trade name
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for a cell preparation of MAP Cs. Id. at 19 ( citing Spec. ,r 79). The
Examiner also notes that Appellants' Specification acknowledges that
MAPCs were "first isolated by Catherine Verfaillie," one of the inventors
named on the Verfaillie reference. Id. (quoting Spec. ,r 116).
The Examiner therefore fmds that Verfaillie and Appellants'
Specification disclose an identical population ofMAPCs. Ans. 19. As such,
the Examiner fmds, the identical populations ofMAPCs would inherently
secrete the same proangiogenic factors as well as promote angiogenesis. Id.
The Examiner fmds Appellants have offered no evidence of record
suggesting that identical populations of MAP Cs would, for some reason, not
secrete the same three pro-angiogenic factors. Id. ( citing MPEP §§ 2112(V),
2112.0l(I), and2112.0l(II). The Examiner therefore fmds that identical
cells would necessarily inherently secrete the same factors; i.e., identical
populations ofMAPCs would inherently express and/or secrete VEGF,
CXCL5, and IL-8. Id.
We are not persuaded by Appellants' arguments. As we have
explained supra, we are not persuaded by Appellants that Verfaillie neither
teaches nor suggests that MAP Cs promote angiogenesis. Furthermore, we
agree with the Examiner that Appellants' Specification also discloses that
MAPCs secrete VEGF, CXCL5, andIL-8. Spec. ,r 170.
Despite the fact that MAP Cs were not known, at the time of invention,
to secrete the recited pro-angiogenic factors necessary to promote
angiogenesis, 2 Verfaillie teaches that MAPCs were nevertheless known to
2 With the exception ofVEGF, which Verfaillie teaches may be secreted by
MAPCs. See Verfaillie if76.
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promote angiogenesis, and the remaining angiogenesis-promoting cytokines
were taught by the prior art. Thus, as we have explained supra, even if it
was not known at the time of invention that MAP Cs produce VEGF,
CXCL5, and IL-8, we agree with the Examiner that a person of ordinary
skill in the art would have been motivated to assay for these cytokines due to
their known angiogenic properties. We consequently affirm the Examiner's
rejection of the claims.
DECISION
The Examiner's rejection of claims 16-27 under 35 U.S.C.
§ 103(a) is affrrmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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