Ex Parte Woda et al

Patent Trial and Appeal Board

Jan 10, 2017

12840722 (P.T.A.B. Jan. 10, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/840,722 07/21/2010 Juliana Megan Woda ATY-0004US 1637
26294 7590 01/12/2017
TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300 EAST NINTH STREET, SUITE 1700
CLEVELAND, OH 44114
EXAMINER
PYLA, PAUL D
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
01/12/2017 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 STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JULIANA MEGAN WODA and WOUTER VAN’T HOF1
Appeal 2015-006005
Application 12/840,722
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of assessing cells for the ability to have a specified effect on leukocytes and
on endothelial cells. The Examiner rejected the claims on appeal as
anticipated under 35 U.S.C. § 102(b), on the ground of non-statutory
obviousness-type double patenting, and for failure to comply with the
enablement requirement under 35 U.S.C. § 112(a).
We affirm.
STATEMENT OF THE CASE
Claims 10—13 are on appeal. Claim 10, the only independent claim, is
illustrative and reads as follows:
1 Appellants identify the Real Party in Interest as ABT Holding Company.
Br. 3.
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Application 12/840,722
10. A method comprising assessing cells for the ability to
have at least one effect on leukocytes and on endothelial
cells, the at least one effect being: (1) reducing leukocyte
extravasation, (2) reducing leukocyte adhesion to
vascular endothelium or to isolated endothelial cells, (3)
reducing cytokine-mediated activation of endothelial
cells, or ( 4) reducing expression of one or more cell
adhesion molecules on endothelial cells, the cells that are
assessed for the ability being non-embryonic, non-germ
cells that express one or more of oct4, telomerase, rex-1,
or rox-1 and can differentiate into cell types of at least
two of endodermal, ectodermal, and mesodermal germ
layers.
The claims stand rejected as follows:
Claims 10—13 under U.S.C. § 102 as anticipated by Jiang2 as
evidenced by Weng,3 Herbein,4 and Zhang.5
Claims 10-13 under U.S.C. § 102 as anticipated by Furcht6 as
evidenced by Weng, Herbein, and Zhang.
2 Jiang et al., Multipotent Progenitor Cells can be Isolated from Postnatal
Murine Bone Marrow, Muscle and Brain, 30 Experimental Hematology
896-904 (2002) (“Jiang”).
3 Weng, Interplay Between Telomere Length and Telomerase in Human
Leukocyte Differentiation and Aging, 70 Journal of Leukocyte Biology,
861-867 (2001) (“Weng”).
4 Herbein et al., Tumor Necrosis Factor (TNF)-a and TNF Receptors in
Viral Pathogenesis, 223(3) Proc. Soc. Exp. Biol. Med. 241—257 (2000)
(“Herbein”).
5 Zhang et al., Immunosuppressive Properties of Cloned Bone Marrow
Mesenchymal Stem Cells, 17 Cell Research 240—248 (2007) (“Zhang”).
6 Furcht et al., US Patent Publication No. 2006/0030041 Al, published Feb.
9, 2006 (“Furcht”).
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Application 12/840,722
In the Examiner's Answer, the Examiner withdrew the pending
rejection of claims 10-13 under 35 U.S.C. § 112 (a) for failing to comply
with the enablement requirement. Ans. 3. This issue is thus no longer a part
of this appeal.
The Examiner provisionally rejected Claims 10—13 on the grounds of
non-statutory obviousness-type double patenting over claim 13 of US Patent
Application No. 12/840,420 and over claims 14, 21, 25, and 26 of US Patent
Application No. 13/071,801. Appellants do not address the Examiner’s
double patenting rejections. We therefore summarily affirm the
obviousness-type double patenting rejections. See Manual of Patent
Examining Procedure § 1205.02 (“If a ground of rejection stated by the
examiner is not addressed in the appellant’s brief, that ground of rejection
will be summarily sustained by the Board.”).
OBVIOUSNESS OVER JIANG, WENG, HERBEIN, AND ZHANG
The Examiner found that Jiang taught multipotent adult progenitor
cells (“MAPCs”) in bone marrow. Ans. 6. In finding claims 10—13
anticipated, the Examiner found that Jiang’s MAPCs inherently
differentiated into cells that have the properties recited in the claims. The
Examiner explained:
Since the prior art reference Jiang has the characteristics
needed within a cell (i.e., MAPCs that proliferate without
senescence and differentiate into mesodermal,
neuroectodermal, and endodermal cell types (Abstract)
and expresses the transcription factors rex-1 and oct-4
(page 903, column 2, paragraph 4)), such MAPCs []
would inherently have the capability to further
differentiate to myeloid progenitor cell, then to monocytes
and macrophages. In light of the above and that it is well
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Application 12/840,722
known in the art that that monocytes and macrophages
express telomerase express soluble TNF receptors (which
down regulate[] TNFa inflammation; see the above
evidentiary references; herein relied upon), the MAPCs
will inherently fit into the criteria of effects (l)-(3) since
such effects are further innate characteristics of the
assessed cells.
Ans. 25—26. The Examiner then concluded that recognizing the presence or
absence a marker — like the expression of rex-1 and oct-4 — met the
requirement of assessing cells for the ability to have the identified effects.
Id. at 26—27.
Appellants argue, inter alia, that assessing MAPC cells for rex-1 or
oct-4 is not the same as or equivalent to assessing cells for the effects recited
in claim 10. App. Br. 11. Appellants argue that the Examiner has
“presented no relationship between any of these genes and [the effects
identified in claim 10].” Id. Appellants explain that even if MAPCs
inherently affect leukocytes and/or endothelial cells in the manner recited in
claim 10, Jiang does not disclose or suggest conducting an assay for these
effects. Id.
We find that Appellants have the better position. The Examiner finds
that recognizing the presence of a marker like rex-1 or oct-4 meets the
requirement for “assessing cells for the ability to have at least one effect on
leukocytes and on endothelial cells.” But the Examiner has not established
any relationship between the expression of markers like rex-1 and oct-4 and
the effects MAPCs have on leukocytes and/or endothelial cells to draw this
conclusion. The Examiner’s position is that the cells that exert the claimed
effects are monocytes and macrophages, not MAPCs. (As discussed above,
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Application 12/840,722
the Examiner’s position is that MAPCs cells differentiate into myeloid
progenitor cells, which differentiate into monocytes and macrophages,
which exert an effect on leukocytes and endothelial cells). The Examiner
does not explain how the presence of rex-1 or oct-4 in the MAPCs reflects
upon the ability of monocytes and macrophages to effect leukocytes and
endothelial cells. Moreover, it is the MAPCs themselves — not the
monocytes and macrophages — that the claims require to be assessed for their
ability to effect leukocytes and endothelial cells. Accordingly, on the record
before us, we find that the Examiner has not established that assessing
MAPCs for the presence of rex-1 or oct-4 meets the requirement for
“assessing cells for the ability to have at least one effect on leukocytes and
on endothelial cells.”
We note that we were recently asked to decide a similar issue with
respect to another of Appellants’ applications. See, Appeal No. 2014-
009100 (“Ax Parte Mays”). While the application at issue in that case is not
directly related to the pending application, both applications related to the
properties of MAPCs. The claims in Ex Parte Mays were directed to a
“method of obtaining cells having a desired potency.” The method included
the step “assaying cells for the desired potency.” We found that the prior art
disclosed methods of obtaining MAPCs that inherently possessed the desired
potency and, under In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed.
Cir. 2002), the requirement to recognize the inherent properties of the cells
obtained did not lend patentability to the claimed method of obtaining cells.
The claims at issue here differ from those in Mays and Cruciferous
Sprout because they do not attempt to confer patentability on an old process
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Application 12/840,722
by adding a limitation requiring the recognition of previously undiscovered
inherent properties. In Mays and Cruciferous Sprout, the claimed method
had been performed in the art, and “it mattered] not that those of ordinary
skill heretofore may not have recognized [the] inherent characteristics.”
Here, the Examiner has not provided evidence that the method recited in the
claims has been performed in the art.
The claims at issue further differ from those in Mays in that they
require that specific assessments be made with respect to the ability of cells
“to have at least one effect on leukocytes and on endothelial cells.” In Mays,
we determined that the claims did not did not require any specific assays to
be performed and thus could be satisfied by any method that showed the
cells obtained to be cells of the type that inherently has the claimed potency
Accordingly we reverse the Examiner’s rejection of claims 10—13
over the combination of Jiang, Weng, Herbein, and Zhang.
OBVIOUSNESS OVER FURCHT, WENG, HERBEIN, AND ZHANG
The disclosure of Frucht is, in relevant part, similar to that of Jiang.
The arguments presented by Appellants and by the Examiner with respect to
the combination of Furcht, Weng, Herbein, and Zhang are substantially the
same as those with respect to the combination of Jiang, Weng, Herbein, and
Zhang. Accordingly, we reverse the Examiner’s rejection of claims 10—13
over the combination of Furcht, Weng, Herbein, and Zhang for that reasons
provided above with respect to the combination of Jiang, Weng, Herbein,
and Zhang.
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Application 12/840,722
SUMMARY
The Examiner’s final decision to reject claims 10—13 as obvious over
the combination of Jiang, Weng, Herbein, and Zhang is reversed.
The Examiner’s final decision to reject claims 10—13 as obvious over
the combination of Furcht, Weng, Herbein, and Zhang is reversed.
The Examiner’s final decision to reject claims 10—13 on the ground of
non-statutory obviousness-type double patenting over claim 13 of US Patent
Application No. 12/840,420 is affirmed.
The Examiner’s final decision to reject claims 10—13 on the ground of
non-statutory obviousness-type double patenting over claims 14, 21, 25, and
26 of US Patent Application No. 13/071,801 is affirmed.
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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