Ex Parte Varner

Patent Trial and Appeal Board

Mar 28, 2016

10573944 (P.T.A.B. Mar. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/573,944 03/14/2007 Judith A. Varner
23535 7590 03/29/2016
MEDLEN & CARROLL, LLP
1440 Broadway
SUITE 510
Oakland, CA 94612
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.
UCSD-10834 2052
EXAMINER
BEL YA VSKYI, MICHAIL A
ART UNIT PAPER NUMBER
1644
MAILDATE DELIVERY MODE
03/29/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUDITH A. VARNER 1
Appeal2014-000217
Application 10/573,944
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant states the real party-in-interest is The Regents of the University
of California, Oakland, California. App. Br. 3.
Appeal2014-000217
Application 10/573,944
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-10, 14, 17-22, 34, and 35 as
unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Papayannopoulou et al. (WO 94/11027, May 26, 1994)
("Papayannopoulou"), Varner et al. (WO 03/019136 A2, March 6, 2003)
("Varner"), and Karen P. Schofield et al., Influence of Interleukin-3 and
Other Growth Factors on a4fJ1 Integrin Mediated Adhesion and Migration of
Human Hematopoietic Progenitor Cells, 90(5) BLOOD 1858---66 (1997)
("Schofield"). 2 Final Act. 6.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to providing methods for altering
hematopoietic progenitor cell adhesion and/or migration to a target tissue,
and for altering hematopoietic progenitor cell differentiation into a second
cell type. The invention also provides methods for screening test
compounds for altering the level of hematopoietic progenitor cell adhesion
and/or migration to a target tissue, and for altering hematopoietic progenitor
cell differentiation into a second cell type. The invention further provides
methods for isolating hematopoietic progenitor cells. Abstract.
2 Claims 11-13, 15, 16, and 32-33 are canceled. Claims 23-31 are
withdrawn. App. Br. Claim App'x ii-v.
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Application 10/573,944
REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal and
recites:
1. A method for detecting an altered level ofhematopoietic
progenitor cell adhesion to target tissue, comprising:
a) providing:
i) a population of cells compnsmg
hematopoietic progenitor cells that express
integrin a4B1,
ii) target tissue that is not bone marrow
endothelial tissue, and
iii) one or more agent that alters specific binding
of integrin a4B1 to an integrin a4B1 ligand,
b) treating one or more of said population of cells and
said target tissue with said agent under conditions
for specific binding of said integrin a4B1 with said
integrin a4B1 ligand, wherein said treating is in vivo
in a mammalian subject having a non-angiogenic
disease, and
c) detecting an altered level of adhesion of said
hematopoietic progenitor cells to said target tissue
that is not bone marrow endothelial tissue.
App. Br. Claim App 'x i.
ISSUES AND ANALYSES
We do not agree with, or adopt, the Examiner's findings and
conclusion that the claims on appeal are prima facie obvious. See Final Act.
2-5. We address Appellant's arguments below.
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Appeal2014-000217
Application 10/573,944
Issue 1
Did Examiner err by failing to address the limitations incorporated as
amendments to the claims, as well as the language of new independent claim
35?
Analysis
Appellant states that, in the non-Final Office Action of August 31,
2012, the Examiner allegedly acknowledged that although there was a
difference between the "peripheralization phenomenon," as taught by
Papayannopoulou, and the "adhesion phenomenon," as taught by Varner, but
justified the combination of the references (together with Schofield) as the
predictable result of elements well-known in the art, with no change in their
respective functions. App. Br. 5---6 (citing KSR International Co. v. Teleflex
Inc., 550 U.S. 398, (2007)).
In response to the Examiner's findings, Appellant argued that: 1)
Papayannopoulou contradicts the Examiner's argument because it is silent
regarding the alleged "correlation" between peripheralization and adhesion;
2) the references fail to teach the recited methods with respect to "non-
angiogenic disease"; and 3) the Examiner had previously conceded that
Varner failed to teach both "adhesion" and "hematopoietic progenitor cells."
App. Br. 6 (citing communication dated November 30, 2012).
Appellant points out that, prior to the Final Office Action,
independent claims 1 and 34 were amended to recite the limitation of
dependent claim 16 reciting "wherein said treating is in vivo in a mammalian
subject having non-angiogenic disease" and, further, added new claim 35
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(further requiring that the non-angiogenic disease "is selected from the
group consisting of fibrosis and atherosclerosis"). App. Br. 6.
However, Appellant contends, in the Final Office Action, the
Examiner allegedly ignored the amendments to independent claims 1 and 34,
and new claim 3 5 in its entirety, choosing instead to reiterate the original
arguments regarding adhesion and peripheralization. App. Br. 6. Appellant
maintains her disagreement with the Examiner's findings on the merits but,
on appeal, argues the Examiner is not free to ignore limitations recited in
new and amended claims. Id. Appellant contends that, since the most recent
rejection fails to show any findings as to where the cited art teaches "non -
angiogenic disease" such as "fibrosis and atherosclerosis," either alone or in
combination, the rejections are improper and should be withdrawn. Id.
The Examiner responds that Papayannopoulou teaches administering
a VLA-4 antigen blocking agent into the patient. Ans. 4 (citing
Papayannopoulou 12, 15, 25). The Examiner finds such administration
would result in the treatment of various target tissues that express the a4B1
integrin ligand. Id. The Examiner concludes that it would have been
obvious to a person of ordinary skill in the art that Papayannopoulou
therefore teaches "in vivo treatment." Id.
With respect to the limitation reciting "mammalian subject having a
non-angiogenic disease," the Examiner finds the claims are drawn to a
method for detecting altered levels of hematopoietic progenitor cell adhesion
to target tissues, using one or more agent that alters specific binding of a4B1
integrin to an integrin a4B1 ligand. Ans. 4. Specifically, the Examiner finds,
Appellant's invention relates to the phenomenon of detecting altered levels
of adhesion, and not to the method of treating any specific disease. Id. The
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Application 10/573,944
Examiner finds Appellant's Specification discloses the invention is not
limited to any specific disease, rather, one embodiment recites the disease is
angiogenic, and in another, non-angiogenic. Id. at 5 (citing Spec. 4). The
Examiner explains that the essence of the invention is therefore the
phenomenon of detecting altered level of adhesion, and not the treatment of
any specific disease. Id.
The Examiner points to the submitted Declaration of Dr. Cheresh, in
which Dr. Cheresh states that Papayannopoulou teaches a method of
detecting the increasing number of the hematopoietic stem cells that are
released into peripheral blood. Ans. 5 (citing Declaration of Dr. David
Cheresh, April 23, 2007) (the "Cheresh Declaration"). The Examiner
concludes it would be obvious to one skill in the art that integrin a4B1, which
causes the release, alters the binding of the membrane protein on one cell
type with a second molecule that is on the surface of another cell type, i.e.,
altered the adhesion of one cell type to another cell type. Id. The Examiner
therefore finds that, though peripheralization is different from adhesion, a
person of skill in the art would immediately understand that measuring the
level of peripheralization can obviously indicate an altered level of
progenitor cell adhesion. Id.
The Examiner further finds V amer teaches, in a preferred
embodiment, the subject has angiogenic disease. Ans. 5 (citing Varner 4).
The Examiner concludes it would be immediately obvious to one of skill in
the art that non-preferred embodiments would include treatment of subjects
with non-angiogenic disease. Id. (citing, inter alia, MPEP § 2123).
Finally, the Examiner finds claim 35 was included in the rejections
because, it would be conventional and within the skill of an ordinary artisan
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to identify any specific type non-angiogenic disease and because, where the
general conditions of a claim are disclosed in the prior art, discovering the
optimum or workable ranges requires only routine skill in the art. Ans. 6
(citing Aller, 220 F2d 454, 456 (C.C.P.A. 1955).
Appellant replies that the Examiner's findings that the "essence of the
invention is [ ... ] the phenomenon of detecting altered level of adhesion, and
not the treatment of any specific disease" is error on the part of the
Examiner; an invention cannot be distilled down to its "gist" or "thrust"' at
the expense of the subject matter "as a whole." Reply Br. 2 (citing MPEP §
2141).
We are persuaded by Appellant's arguments. In the Final Office
Action, the Examiner failed to produce any findings of fact or conclusions of
law with respect to the limitation reciting "wherein said treating is in vivo in
a mammalian subject having non-angiogenic disease."3
We agree with Appellant that the Final Office Action does not address
either the limitation added by amendment prior to the Final Office Action,
nor does it address claim 35, also added at that time. The Examiner's
findings concerning the "essence" of the claim may or may not have merit in
themselves, but the Final Office Action does not anywhere address the
specific claim requirements for in vivo treatments in mammals with non-
angiogenic disease. "[T]he name of the game is the claim." In re Hiniker
Co., 150 F. 3d 1362, 1369 (Fed. Cir. 1998).
3 We recognize, but do not find persuasive, the Examiner's unsupported
conclusion that a teaching of angiogenic disease renders non-angiogenic
disease "immediately obvious." Ans. 5.
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Application 10/573,944
Papayannopoulou teaches methods for peripheralizing hematopoietic
stem cells by administering a blocking agent of VLA-4 ( a4B 1) antigen on
the surface of the stem cells. See Papayannopoulou Abstr. However,
Papayannopoulou does not teach in vivo treatment of mammals with non-
angiogenic disease. Valmer teaches, inter alia, in vivo use of an agent which
inhibits specific binding of integrin a4B1 to an integrin a4B1 ligand as a means
of treating a mammal with an angiogenic disease, but is silent with respect to
mammals with non-angiogenic diseases. See Varner 7-8. Because the cited
prior art does not teach the specific limitation of "wherein said treating is in
vivo in a mammalian subject having non-angiogenic disease," i.e., because it
does not teach treatment of the explicit group of subjects required by the
limitation, the Examiner has failed to meet the burden of showing that the
claims are obvious, even inherently, over the prior art. See Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed. Cir. 2005).
Similarly, with respect to new claim 35, which requires, inter alia,
wherein said treating is in vivo in a mammalian subject having a non-
angiogenic disease that is selected from the group consisting of fibrosis and
atherosclerosis," the Examiner points to no teaching or suggestion, nor can
we discern one, that teaches treating a mammal with fibrosis and/ or
atherosclerosis.
Moreover, our reviewing court has held that disregarding explicit
limitations in favor of determining the "gist" or "thrust" of an invention is
violative of the statutory requirement that the invention be viewed "as a
whole." See, e.g., Bausch & Lomb v. Barnes-Hind/Hydrocurve, Inc., 796
F.2d 443, 447-49 (Fed. Cir. 1986), cert. denied, 484 U.S. 823 (1987)
(District court focused on the "concept of forming ridgeless depressions
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Application 10/573,944
having smooth rounded edges using a laser beam to vaporize the material,"
but "disregarded express limitations that the product be an ophthalmic lens
formed of a transparent cross-linked polymer and that the laser marks be
surrounded by a smooth surface ofunsublimated polymer"); see also MPEP
§ 2141.02(II)).
Because the Examiner fails to show that the combined cited prior art
teaches or suggests all of the limitations of the claims, we reverse the
Examiner's rejection.
DECISION
The Examiner's rejection of claims 1-10, 14, 17-22, 34, and 35 as
unpatentable under 35 U.S.C. § 103(a) is reversed.
REVERSED
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