Ex Parte Merchav et al

Patent Trial and Appeal Board

Aug 2, 2016

12230566 (P.T.A.B. Aug. 2, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/230,566 09/02/2008
23628 7590 08/04/2016
WOLF GREENFIELD & SACKS, P.C.
600 ATLANTIC A VENUE
BOSTON, MA 02210-2206
FIRST NAMED INVENTOR
Shoshana Merchav
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.
Pl023.70001US01 2775
EXAMINER
HUMPHREY, LOUISE WANG ZHIYING
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
08/04/2016 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHOSHANA MERCHA V, SHAI MERETSKI,
DOV ZIPORI, and A VINOAM KADOURI 1
Appeal2013-002228
Application 12/230,566
Technology Center 1600
Before DONALD E. ADAMS, LORA M. GREEN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
HARLOW, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a cell
culture. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Pluristem Ltd. (App.
Br. 2).
Appeal2013-002228
Application 12/230,566
The Specification describes "a method and apparatus for maintenance
and expansion of hemopoietic stem cells" (Spec. 1: 16-17).
Claims 32--47 are on appeal. Claim 32, the lone independent claim on
appeal, is illustrative and reads as follows:
32. A cell culture comprising adherent stromal cells
capable of supporting expansion of undifferentiated
hematopoietic stem cells on a matrix comprising a
three dimensional substrate, wherein the adherent
stromal cells are grown to confluence.
The claims stand rejected as follows:
Claims 32--47 stand rejected under 35 U.S.C. § 112, first paragraph as
failing to comply with the written description requirement.
Claims 32--47 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Naughton2 and Sussman.3
I.
Issue
The Examiner has rejected claims 32--47 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement.
Because the claims are not separately argued, we focus our discussion on
independent claim 32.
The Examiner finds that "[t]he specification nowhere describes the
invention as being a cell culture comprising adherent stromal cells as
required by the instant claims" (Ans. 5). In particular, the Examiner finds
that the Specification "discloses a plug-flow bioreactor system has been
2 Naughton et al., US 5,541,107, issued July 30, 1996.
3 Sussman et al., US 5,266,476, issued Nov. 30, 1993.
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Application 12/230,566
developed \vhich is capable of supporting the grov,rth and prolonged
maintenance of stromal cells" (id. at 4), and each embodiment described in
the Specification "involves propagating [the] stromal cells on the matrix in
the plug-flow bioreactor" (id. at 5). The Examiner also observes that the
claims on appeal were introduced by a preliminary amendment, and "have
not been presented as original claims in a parent application" (id.). The
Examiner, thus, concludes that "the plug-flow bioreactor limits the scope of
the invention, since all described aspects of the invention require the plug-
flow bioreactor for cell culture. Description of a cell culture without the
plug-flow bioreactor is not found in the specification" (id. at 9).
The issue presented is whether the Examiner erred in rejecting
claim 32 as failing to comply with the written description requirement.
Principles of Law
[T]he purpose of the written description requirement is to ensure
that the scope of the right to exclude, as set forth in the claims,
does not overreach the scope of the inventor's contribution to the
field of art as described in the patent specification. It is part of
the quid pro quo of the patent grant and ensures that the public
receives a meaningful disclosure in exchange for being excluded
from practicing an invention for a period of time.
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir.
2010) (internal quotations and citations omitted).
However, "the patentee need only describe the invention as claimed,
and need not describe an unclaimed method of making the claimed product."
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1333 (Fed.
Cir. 2003). Furthermore, "[a] claim will not be invalidated on section 112
grounds simply because the embodiments of the specification do not contain
examples explicitly covering the full scope of the claim language."
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Application 12/230,566
LizardTech, Inc. v. Earth Res. 1'.1apping, Inc., 424 F.3d 1336, 1345 (Fed.
Cir. 2005).
Analysis
We agree with Appellants that the Examiner erred in rejecting
claim 32 as failing to comply with the written description requirement.
Claim 32 is directed to a cell culture exhibiting particular
characteristics; it does not pertain to a method for generating such a cell
culture, or a method for using that culture (see App. Br. 7). Accordingly,
although we agree with the Examiner that the Specification describes
growing the claimed cell cultures in a plug-flow reactor (see Ans. 8-9), we
do not agree that the Specification's description of using a plug-flow reactor
to reduce the claimed product to practice supports a finding that the claimed
cell culture is itself inadequately described. See Amgen Inc., 314 F .3d at
13 3 3 (no requirement to "describe an unclaimed method of making the
claimed product"); LizardTech, Inc.; 424 F.3d at 1345 (examples need not
"explicitly cover[] the full scope of the claim language"). Nor do we agree
that the absence of description in the Specification of the cell culture being
maintained outside of the plug-flow bioreactor (Ans. 9) renders claim 32
inadequately described. Rather, we agree with Appellants that the
Specification's description of growing the claimed cell culture "in a plug-
flow bioreactor is immaterial to whether the [cell] culture itself is
sufficiently described, or whether the bioreactor must itself be claimed"
(Reply Br. 3). We, therefore, reverse the written description rejection.
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Application 12/230,566
Conclusion of La1lv
A preponderance of the evidence of record does not support the
Examiner's rejection of claim 32 as failing to comply with the written
description requirement. Because they depend from claim 32, the rejection
of claims 33--47 is also reversed. In re Fine, 837 F.2d 1071, 1076 (Fed. Cir
1988).
II.
Issue
The Examiner has rejected claims 32--47 under 35 U.S.C. § 103(a) as
being unpatentable over Naughton and Sussman. Because the claims are not
separately argued, we focus our discussion on independent claim 32, which
is representative. 4
The Examiner finds that Naughton discloses "growing stromal cells
on a three-dimensional matrix which can be formed from a polymeric
material to produce a three-dimensional stromal matrix (col 9, lines 16-20
and 49-51 and col 13, lines 8-14)," and "inoculating the stromal matrix with
stem cells (col 15, lines 41and57 and Col 21, lines 3, 9, and 26) such as
hematopoietic stem cells (col 21, line 3)" (Ans. 6). The Examiner further
finds that Naughton discloses "maintaining the stem cells on the matrix in
vitro where proliferation of the cells is maximized (col 21, lines 2-3), and
4 Appellants state that the Examiner did not provide adequate support for the
rejection of the dependent claims on appeal, but do not off er argument as to
why the rejection of any of those claims is improper (App Br. 8). "Since the
claims are not separately argued, they all stand or fall together." In re
Kaslow, 707 F.2d 1366, 1376 (Fed. Cir. 1983).
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Application 12/230,566
implanting the stem cells in vivo to repopulate bone marro\'l/ (col 16,
lines 58-67 and col 21 , lines 4-5)" (Ans. 6).
The Examiner finds that Naughton discloses that
[i]t is preferable to inoculate hematopoietic cells onto a stromal
matrix which is subconfluent because confluent stromal cells
poorly support hematopoiesis (col 9, lines 64-67, and col 25,
lines 35-44). When keratinocytes and/or melanocytes for
producing dermal structure of skin are inoculated on the stromal
matrix, it is preferred to allow the stromal cells to reach
confluence (col 10, lines 1-8).
(Ans. 7).
The Examiner finds that Sussman discloses "a fibrous matrix for cell
cultivation," and the use of such matrix to grow cells to confluence (id.).
The Examiner concludes that it would have been obvious to use the
fibrous matrix of Sussman as the three-dimensional matrix of Naughton
to obtain the properties of the fibrous matrix providing increased
attachment surface for adherence of cells, adequate porosity for
entrance of cells and nutrients and for removal of wastes, and
being a matrix suitable for growing cells to confluence. This will
result in a cell culture comprising adherent stromal cells on a
matrix required by the instant claims when growing stromal cells
to confluence as disclosed by Naughton et al. The confluent
stromal cells will inherently be capable of supporting expansion
of undifferentiated hematopoietic stem cells.
(Id.)
The issue presented is whether the Examiner erred in rejecting claims
32--47 as obvious over the combination of Naughton and Sussman.
Findings of Fact
We adopt the Examiner's findings regarding the scope and content of
the prior art, and highlight the following for context.
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Application 12/230,566
FF 1. Naughton discloses that "cells derived from a desired tissue
(herein referred to as tissue-specific cells or parenchymal cells) are
inoculated and cultured on a preestablished three-dimensional stromal
matrix. The stromal matrix comprises stromal cells grown on a three-
dimensional matrix or network" (Naughton 9: 13-18).
FF 2. Naughton discloses that "[t]he three-dimensional culture system
of [Naughton's] invention appears to maximize the proliferation of
multipotential hematopoietic stem cells which have the capability of
repopulating bone marrow when the bone marrow has been destroyed by
intrinsically or environmentally-mediated disease or by the treatment of such
disease with chemotherapy and/ or radiation" (Naughton 21 : 1-7). Naughton
further discloses that the "hematopoietic progenitors and hematopoietic
precursors of all blood cell lineages appear to replicate and proliferate in
[Naughton' s] three-dimensional stromal system" (Naughton 21: 18-21 ).
FF 3. Naughton discloses that
Because, according to [Naughton' s] invention, it is
important to recreate, in culture, the cellular microenvironment
found in vivo for a particular tissue, the extent to which the
stromal cells are grown prior to inoculation of parenchymal cells
may vary depending on the type of tissue to be grown in three-
dimensional tissue culture. For example, in bone marrow three-
dimensional cultures, it is preferable to inoculate hematopoietic
cells onto a stromal matrix which is subconfluent. However, in
skin three-dimensional tissue cultures, it is preferred, according
to the invention, to allow the stromal cells to reach confluence
prior to inoculation with keratinocytes and/ or melanocytes, so as
to recreate the structure of the dermal component of skin.
(Naughton 9:59-10:4.)
FF 4. Sussman discloses that "cells coming in contact with
[appropriate] surfaces will attach themselves to the surface, and reproduce
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Application 12/230,566
until they cover the surfaces in a contiguous, confluent monolayer"
(Sussman 1 :43--46).
Principles of Law
Although a reference that teaches away is a significant factor to
be considered in determining unobviousness, the nature of the
teaching is highly relevant, and must be weighed in substance.
A known or obvious composition does not become patentable
simply because it has been described as somewhat inferior to
some other product for the same use.
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Where there is reason to conclude that the prior art structure is
"capable of' performing a claimed function, the burden shifts to the
applicant to show that the claimed function patentably distinguishes the
claimed structure from the prior art structure. In re Hallman, 655 F.2d 212,
215 (CCPA 1981).
Analysis
We have considered, but do not find persuasive, Appellants'
arguments that the Examiner erred in rejecting claims 32 as obvious over
Naughton and Sussman. We address Appellants' arguments below.
As an initial matter, we disagree with Appellants' assertion (App.
Br. 9 n.2; see also Reply Br. 4--5) that reversal is appropriate because the
Examiner did not explicitly apply one of the rationales set forth in the
Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103
in View of the Supreme Court Decision in KSR International Co. v. Teleflex
Inc. See 72 Fed. Reg. 57526 (Oct. 10, 2007) ("any failure by Office
personnel to follow the guidelines is neither appealable nor petitionable").
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Application 12/230,566
\Ve are likev,rise unpersuaded by 1A .. ppellants contention that Naughton
"teaches away from a cell culture comprising adherent stromal cells capable
of supporting expansion of undifferentiated hematopoietic stem cells on a
matrix comprising a three dimensional substrate and when [sic] the adherent
stromal cells are grown to confluence" (App. Br. 9; see also Reply Br. 5---6).
Although Appellants are correct that Naughton discloses that "it is
preferable to inoculate hematopoietic cells onto a stromal matrix which is
subconfluent" (FF 3), Naughton's stated preference for subconfluent stromal
matrices to support hematopoietic cells does not constitute a teaching away
from the functional claim requirement that the "adherent stromal cells" be
"capable of supporting expansion of undifferentiated hematopoietic stem
cells on a matrix comprising a three dimensional substrate" (claim 32
(emphasis added)) sufficient to support reversal of the obviousness rejection.
See In re Gurley, 27 F.3d at 553 ("A known or obvious composition does
not become patentable simply because it has been described as somewhat
inferior to some other product for the same use."); cf In re Swinehart, 439
F.2d 210, 213 (C.C.P.A. 1971) ("'Functional' terminology may render a
claim quite broad. By its own literal terms a claim employing such language
covers any and all embodiments which perform the recited function.").
Furthermore, we agree with the Examiner (Ans. 7) that confluent
adherent stromal cells, which Naughton discloses are particularly useful for
supporting keratinocytes and melanocytes (FF 3), and which Sussman
discloses as useful in prior art cell culture systems (FF 4), would necessarily
be "capable of supporting expansion of undifferentiated hematopoietic stem
cells on a matrix comprising a three dimensional substrate," as required by
claim 32.
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Application 12/230,566
\Ve also observe that 1A .. ppellants have not presented persuasive
argument or evidence to show otherwise. See In re Echerd, 471F.2d632,
635 (CCPA 1973) ("the Patent Office may properly require proof that the
functional limitations being relied upon are not inherent characteristics of
the prior art" (citation omitted)). For example, although Appellants state
that "Naughton teaches that its confluent cell cultures lack [the claimed]
functional capacity" (App. Br. 11 ), Appellants do not identify where in
Naughton such teaching is made. Rather, Appellants rely exclusively on
Naughton' s disclosures that sub confluent stromal cells are preferred for use
with hematopoietic stem cells (id. at 9-10). For the reasons explained
above, however, Naughton' s statement of a preference for using
subconfluent stromal cells does not amount to a teaching that confluent
stromal cells are incapable of supporting the expansion of undifferentiated
hematopoietic stem cells on a matrix comprising a three dimensional
substrate.
We are also unpersuaded by Appellants' argument that the cultures
disclosed by Naughton differentiate, and thus the disclosed stromal cells
"cannot be said to support expansion of undifferentiated hematopoietic
cells" (id. at 10). We agree with the Examiner that claim 32 "is not limited
to supporting only expansion of undifferentiated hematopoietic stem cells,"
but rather, requires only that the adherent stromal cells be "capable of'
supporting such cells (Ans. 10). As discussed above, we agree with the
Examiner that the confluent adherent stromal cells of the cited combination
would necessarily be "capable of supporting expansion of undifferentiated
hematopoietic stem cells on a matrix comprising a three dimensional
substrate," as required by claim 32. In addition, we observe that Naughton
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Application 12/230,566
explicitly discloses that "[t]he three-dimensional culture system of
[Naughton's] invention appears to maximize the proliferation of
multipotential hematopoietic stem cells" and that "hematopoietic progenitors
and hematopoietic precursors of all blood cell lineages appear to replicate
and proliferate in [Naughton's] three-dimensional stromal system" (FF 2).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that the combination of Naughton and Sussman renders claim 32
obvious. Claims 33--47 have not been argued separately and therefore fall
with claim 32.
SUMMARY
We reverse the rejection of claims 32--47 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement.
We affirm the rejection of claim 32 under 35 U.S.C. § 103(a) based on
the combination ofNaughton and Sussman. Claims 33--47 fall with
claim 32.
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Application 12/230,566
TI1\1E PERIOD FOR RESPONSE
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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