Ex Parte Clarke et al

Patent Trial and Appeal Board

May 24, 2016

11150524 (P.T.A.B. May. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111150,524 06/10/2005
72960 7590 05/26/2016
Casimir Jones, S.C.
2275 DEMING WAY, SUITE 310
MIDDLETON, WI 53562
FIRST NAMED INVENTOR
Michael F. Clarke
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.
UM-09943 3257
EXAMINER
LI, QIAN JANICE
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
05/26/2016 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):
docketing@casimirjones.com
pto .correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL F. CLARKE, SEAN J. MORRISON,
MAX S. WICHA, and MUHAMMAD AL-HAJJ1
Appeal2014-004510
Application 11/150,524
Technology Center 1600
Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for obtaining an enriched population of CD44 +cD24-110w solid tumor stem
cells (STSCs ). The Examiner has rejected the claims as indefinite and
nonenabled. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 219--222, 229--233, and 235-239 are on appeal (App. Br. 1).
Claim 219 is illustrative and reads as follows:
1 Appellants identify the real parties in interest as the Regents of the
University of Michigan and OncoMed Pharmaceuticals, Inc. (App. Br. 2).
Appeal20014-004510
Application 11/150,524
219. A method for obtaining a cellular composition comprising an
enriched population of human CD44+cn24-110w solid tumor stem cells, the
method comprising:
(a) obtaining an initial mixture of solid tumor stem cells and solid
tumor cells from a human solid tumor of epithelial origin, wherein the solid
tumor is not from a cell line a primary tumor or a xenograft tumor
established from a primary tumor; and
(b) separating a fraction of solid tumor stem cells from the mixture
of solid tumor stem cells and solid tumor cells, wherein the solid tumor stem
cells are:
(i)
(ii)
(iii)
(iv)
cn44+.
' cn24-/low.
'
enriched at least two-fold compared to the initial
unfractionated mixture of solid tumor stem cells and
solid tumor cells; and
tumorigenic. 2
Claims 219--222 and 235-237 stand rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite (Ans. 3).
Claims 219--222, 229--233, and 235-239 stand rejected under 35
U.S.C. § 112, first paragraph, as lacking enablement (id. at 3--4).
INDEFINITENESS
The Examiner finds:
Claims are vague and indefinite because of the claim (219)
recitation, "(iii) enriched at least two-fold compared to the initial
mixture ... ". It is unclear in what way the solid tumor stem cells
are enriched, and hence the metes and bounds of the claims are
uncertain. Although the preamble of claim 219 recites "an
enriched population of human CD44+CD24-/low[] solid tumor
2 As noted by Appellants, claim 219 includes the phrase "not from a cell
line" (App. Br. 4, ftnt. 2). However, the Examiner agrees that the inclusion
of this phrase is an inadvertent error (Ans. 2). Therefore, for the purpose of
this appeal, we are assuming that this phrase, which is crossed through
herein, has been deleted.
2
Appeal20014-004510
Application 11/150,524
stem cells", given the broadest reasonable interpretation, the
"enriched" recitation does not necessarily limit
"CD44+CD24-/low" in the context of the claim as a whole. The
phrase in the preamble could refer to enriched solid tumor stem
cells in a general sense, not necessarily specifically through
enriching via CD44 and CD24 markers, particularly considering
the criteria set forth in step (b) of claim 219, wherein the phrase
of item (iii) "enriched at least two-fold ... " was in addition to
CD44+ and CD24-/low metrics, and independent from
CD44+CD24-/low.
(Ans. 3.)
Appellants argue:
[A] person skilled in the art reading each of the rejected claims
as a whole, would understand the metes and bounds of what is
claimed. In particular, independent claim 219 . . . is clearly
directed "to a method for obtaining a cellular composition
comprising an enriched population of human cn44+cn24-llow
solid tumor stem cells." The recited method involves the steps
of obtaining an initial mixture of tumor cells and STSCs and
separating a fraction of CD44+cn24-110w STSCs from this initial
cell mixture, wherein the CD44+cn24-110w STSCs are "enriched
at least-two fold compared to the initial unfractionated mixture
of solid tumor stem cells and solid tumor cells" and tumorigenic.
Thus, it is explicitly clear that both uses of the term "enriched"
in claim 219 modify the CD44+cn24-110w STSC fraction that is
separated according to the claimed methods and that this
separated fraction of CD44+cn24-110w STSCs is enriched at least
two-fold compared to the population of these cells in the initial
unfractionated mixture of STSCs and tumor cells.
(App. Br. 6.) We conclude that Appellants have the better position.
Claim 219 recites that "the solid tumor stem cells are ... (iii) enriched
at least two-fold compared to the initial unfractionated mixture of solid
tumor stem cells and solid tumor cells" (App. Br. 15). Thus, claim 219
requires "the solid tumor stem cells," which as recited in the claim are
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Appeal20014-004510
Application 11/150,524
"(i) CD44+; (ii) CD24-110w; ... and (iv) tmnorigenic," to be enriched at least
two-fold (id.). Thus, we conclude that the Examiner has not set forth a
prima facie case that the claims are indefinite.
Conclusion
The Examiner has not set forth a prima facie case that claims 219--222
and 235-237 are indefinite. We therefore reverse the rejection under the
second paragraph of 35 U.S.C. § 112.
ENABLEMENT
The Examiner finds that "the specification, while being enabling for
obtaining/enriching CD44+CD24-110w breast cancer tumor stem cells, does
not reasonably provide enablement for obtaining/enriching colon cancer
tumor stem cells or a genus of solid tumor stem cells of epithelial origin
using the marker combination CD44+ and CD24-110w" (Ans. 3--4).
Appellants argue that "the appropriate inquiry for enablement of the
pending claims is whether a person of ordinary skill in the art could apply
the claimed methods to make and use cellular compositions having the
properties recited in the claims without having to engage in undue
experimentation" (App. Br. 9). Appellants also argue that "the scope of the
claims is limited to those methods that produce cellular compositions having
the properties recited in the claims and not the distended scope created by
the Examiner's improper enablement inquiry" (id. at 12-13). In addition,
Appellants argue:
The central question here, as in In re Wands, is not whether there
are some tumors in which CD44+cn24-110w tumorigenic STSC
populations cannot be enriched. The question here and in In re
Wands is whether there is an appropriate assay or test to analyze
which tumor will yield enriched CD44+cn24-110w STSC
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Appeal20014-004510
Application 11/150,524
populations and which do not, regardless of the percentage of
success. Such a test/assay exists here, and as implicitly
acknowledged by the Examiner on page 7 of the 12/26/12 OA, is
fully disclosed in the specification at for example, paragraphs
[77]-[84], [208]-[239], [245]-[255], and [263]-[266]. Carrying
out the test is routine and does not involve undue
experimentation.
(Id. at 13.)
Principles of Law
"[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without 'undue experimentation."' In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993). However, it "is not a function of the claims to specifically
exclude ... possible inoperative substances." In re Dinh-Nguyen, 492 F.2d
856, 858-59 (CCPA 1974). "Even if some of the claimed combinations
were inoperative, the claims are not necessarily invalid." Atlas Powder Co.
v. E.I. Du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984).
"Of course, if the number of inoperative combinations becomes significant,
and in effect forces one of ordinary skill in the art to experiment unduly in
order to practice the claimed invention, the claims might indeed be invalid."
Id. at 1576-77.
When rejecting a claim under the enablement requirement of
section 112, the 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; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the
scope of enablement.
In re Wright, 999 F.2d at 1561---62.
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Application 11/150,524
The Examiner states:
Analysis
The essential step of the method is obtaining a cellular fraction
separated from a mixture of solid tumor cells, wherein the
fraction contains at least two-fold enriched solid tumor stem cells
compared to fractioned tumor cells, and wherein the tumor stem
cells are identified using markers CD44 + and CD24-110w and
further testing the tumorigenecity [sic] by serial in vivo passages
(tumorigenic ).
(Ans. 4--5.) In addition, the Examiner states:
[A ]lthough the steps of the claimed process were routine to
carryout, given the general state of the pertinent art as taught by
Mordoh, [JJ Clarke, [ 4J and numerous other references of record,
the critical issue was not whether one can carry through the
recited steps but whether the steps will reasonably and
predictively lead to obtaining at least the colon tumor stem cells
and reasonable species of tumor stem cells from different solid
epithelial tumors beyond breast cancer, and whether the
specification establishes the claimed process based on cell
surface phenotype cn44+cn24-/low could indeed enrich
epithelial tumor stem cells beyond breast cancer stem cells.
(Id. at 13-14; see also Final Act. 7.) However, we agree with Appellants
that, while practicing the claimed method steps may not always result in the
claimed enrichment, the Examiner does not adequately explain why it would
not have been within the skill of the art to determine "which tumor will yield
enriched CD44+cn24-110w STSC populations and which do not" (App.
Br. 13).
3 Mordoh et al., US 5,753,229, May 19, 1998.
4 Michael F. Clarke et al., Cancer Stem Cells-Perspectives on Current
Status and Future Directions: AACR Workshop on Cancer Stem Cells, 66
Cancer Res. 9339--44 (2006).
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Application 11/150,524
Conclusion
The Examiner has not set forth a prima facie case that claims 219--
222, 229-233, and 235-239 are not enabled. We therefore reverse the
enablement rejection under the first paragraph of 35 U.S.C. § 112.
REVERSED
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