Ex Parte Carroll et al

Patent Trial and Appeal Board

Feb 29, 2016

10297371 (P.T.A.B. Feb. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/297,371 10/06/2003
26161 7590 03/02/2016
FISH & RICHARDSON P,C (BO)
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022
FIRST NAMED INVENTOR
Michael C. Carroll
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.
1086l-0024US1 1639
EXAMINER
SCHWADRON, RONALD B
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
03/02/2016 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):
P ATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL C. CARROLL,
FRANCIS D. MOORE JR., and HERBERT B. HECHTMAN1
Appeal 2013-011031
Application 10/297,371
Technology Center 1600
Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Immune Disease Institute, Inc.
App. Br. 1.
Appeal 2013-011031
Application 10/297 ,3 71
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 91-95 under 35 U.S.C. § 112, first
paragraph, for failure to comply with the written description requirement. 2
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
NATURE OF THE INVENTION
Appellants' invention is directed to methods and compositions for
treating or preventing immunoglobulin-mediated reperfusion or ischemic
injury. Appellants also disclose methods for identifying inhibitors of an
interaction between a pathogenic immunoglobulin and an ischemic-specific
antigen or a component of the complement pathway. Abstract.
REPRESENTATIVE CLAIM
Appellants argue all of the claims together. App. Br. 3---6.
Independent claim 91 is representative and recites:
91. An isolated immunoglobulin, or antigen binding portion
thereof, that has the same antigenic specificity of an
immunoglobulin produced by the hybridoma having ATCC
Accession Number PTA-3507.
App. Br. 12.
2 Claims 1-13 and 82-95 have been withdrawn, claims 14--81 have been
cancelled, and claim 90 is in condition for allowance. App. Br. 1.
2
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Application 10/297 ,3 71
THE EXAMfNER' S PRIMA F ACIE CASE
The Examiner finds that the claims encompass antibodies with the
same antigenic specificity of the antibody produced by PTA 3507. Ans. 3.
However, the Examiner finds, Appellants' Specification does not disclose or
characterize the identity of the antigen bound by the antibody. Id. The
Examiner therefore finds the identity of the antigen bound by said antibody
is unknown and unpredictable. Id. Consequently, concludes the Examiner,
the written description provided in the specification is not commensurate
with the scope of the claimed invention. Id. We agree with, and adopt
herein, the Examiner's reasoning.
ISSUE
Appellants argue the Examiner erred in finding Appellants'
Specification does not provide adequate written description support for the
claims. App. Br. 4.
ANALYSIS
The first paragraph of 35 U.S.C. § 112 states:
The specification shall contain a written description of the
invention, and of the manner and process of making and using it,
in such full, clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same and shall set
forth the best mode contemplated by the inventor of carrying out
his invention.
Appellants argue the Specification's disclosure of the
immunoglobulin-producing hybridoma deposited with the ATCC provides
sufficient functional description of the claimed immunoglobulin, or antigen
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Appeal 2013-011031
Application 10/297 ,3 71
binding portion, to meet the written description requirement. App. Br. 4--5.
Appellants point to Section 2163(II)(A)(3)(a) of the Manual of Patent
Examining Procedure ("MPEP"), which states that: "disclosure of an antigen
fully characterized by its structure, formula, chemical name, physical
properties, or deposit in a public depository provides an adequate written
description of an antibody claimed by its binding affinity to that antigen."
Id. at 4 (citing Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004)
(holding there is a lack of written descriptive support for an antibody defined
by its binding affinity to an antigen that itself was not adequately
described)). Id. Appellants also point to Enzo Biochem v. Gen-Probe, Inc.,
("Enzo I'') in which our reviewing court held that a deposit in a public
depository can fulfill the written description requirement and further that
"functional claiming is permissible when the claimed material hybridizes to
a disclosed substrate." Id. (citing296F.3d 1316, 1325, 1328 (Fed. Cir.
2002)).
Appellants assert claim 91 recites an isolated immunoglobulin with
the same antigenic specificity of an immunoglobulin produced by the
hybridoma having ATCC Accession Number PTA-3507. App. Br. 4.
According to Appellants, the claimed invention is based on the identification
of pathogenic immunoglobulins that recognize ischemia-specific antigens;
Appellants believe the binding of these immunoglobulins to an ischemia-
specific antigen ultimately results in ischemia or reperfusion injury. Id.
(citing, e.g., Spec. 2, 11. 20-27; 15, 11. 17-25). Appellants point out that a
hybridoma producing the antibodies has been deposited with the ATCC and
that the Examiner does not dispute that Appellants' Specification provides
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Application 10/297 ,3 71
adequate written descriptive support for immunoglobulins produced by that
hybridoma. Id. at 5.
Appellants contend that although the Specification provides no amino
acid sequence of an ischemia-specific antigen, an ischemia-specific antigen
is described functionally as binding to a pathogenic immunoglobulin, such
as that secreted by Appellants' deposited hybridoma, and as being present on
the surface of an endothelial cell. App. Br. 5 (citing Spec. 6-7, 11. 14--1; 8,
11. 1-15; 45, 11. 1-28). Appellants also assert that the ischemia-specific
antigen is described in the Specification as being expressed in response to
ischemic injury. Id. (citing Spec. 2, 11. 20-27; 15, 11. 17-21; 18, 11. 23-25).
Appellants therefore contend the ischemia-specific antigen can be identified
as an antigen that is expressed on the surface of an endothelial cell after
ischemic insult and present in an endothelial cell isolate and also by binding
to an immunoglobulin secreted by the deposited hybridoma. Id. Appellants
also point out that the Specification also teaches that the ischemia-specific
antigen could be obtained from a subject (e.g., a human patient) with
reperfusion or ischemic injury and contacting the same with a pathogenic
immunoglobulin. Id. (citing Spec. 9, 11. 20-24).
Appellants cite, in support of their argument, Noelle, in which they
assert the Federal Circuit held that a mouse antigen was adequately
described because a hybridoma secreting mouse antibodies that bound the
antigen was deposited and described. App. Br. 6 (citing 355 F.3d at 1349).
Appellants therefore contend the antigen of the claim 91 is adequately
described because the Specification describes a deposited hybridoma that
secretes an antibody that binds the antigen. Id.
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Application 10/297 ,3 71
The Examiner responds that Appellants' Specification does not
disclose the identity of the antigen bound by Appellants' claimed
immunoglobulin. Ans. 5. The Examiner finds the identity of the antigen
bound by said antibody is unknown and unpredictable. Id. The Examiner
therefore finds there is no disclosure in Appellants' Specification of the
identity of the antigen bound by the immunoglobulin recited in the claims.
Id.
The Examiner further finds there is no evidence of record that the
antigen bound by the claimed immunoglobulin is even found on endothelial
cells, because there is no experimental evidence in Appellants' Specification
demonstrating that the antigen bound by the claimed antibody is even found
on endothelial cells. Id. The Examiner finds identification of the antigen as
"ischemia specific" is only hypothetical, because the antigen has not been
isolated and it is therefore not possible to determine whether or not the
antigen occurs in normal or injured cells. Id.
The Examiner finds Appellants' arguments concerning Enzo I and
Noelle to be inapposite. Ans. 7. The Examiner points out that, unlike Enzo
I, Appellants have not deposited an ischemia-specific antigen in a public
depository, but have rather deposited a hybridoma that produces monoclonal
antibodies that purportedly bind to the uncharacterized antigen. Id. The
Examiner also finds that, in Enzo I, the claims were restricted to specific
deposited reagents and did not encompass an unknown genus of reagents.
Id.
With respect to Noelle, the Examiner finds the Specification of the
Noelle Application (Application No. 08/742,480) disclosed that the
monoclonal antibody which Noelle produced was used in
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Appeal 2013-011031
Application 10/297 ,3 71
immunoprecipitation experiments to isolate a 39 kd antigen derived from
activated mouse T-cells. Ans. 7 (see Noelle, 355 F.3d at 1343). The
Examiner finds Noelle had thus both isolated, and had physical possession
of, the antigen bound by their monoclonal antibody. Id. By contrast, the
Examiner finds, Appellants have not only not isolated the antigen bound by
the immunoglobulin produced by the PTA-3507 hybridoma, Appellants do
not even know the identity of said antigen. Id.
We are not persuaded by Appellants' argument. The common holding
of Enzo I and Noelle is that an antibody may be functionally claimed only if
the antigen is known, available to the public, and/or sufficiently identified
and characterized. In Enzo Biochem, Inc. v. Gen-Probe Inc. ("Enzo II"), the
Federal Circuit explicitly adopted the PTO's Guidelines for determining
whether a claimed antibody met the written description requirement, stating:
For example, the PTO would find compliance with 112,
paragraph 1, for a claim to an isolated antibody capable of
binding to antigen X, not\~1ithstanding the functional definition
of the antibody, in light of the well defined structural
characteristics for the five classes of antibody, the functional
characteristics of antibody binding, and the fact that the antibody
technology is well developed and mature .... We are persuaded
by the Guidelines on this point and adopt the PTO' s applicable
standard for determining compliance with the written description
requirement.
323 F.3d 956, 964 (Fed. Cir. 2002). The court thus adopted the USPTO
Guidelines as persuasive authority for the proposition that a claim directed to
"any antibody which is capable of binding to antigen X" would have
sufficient support in a written description that disclosed "sufficiently
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Application 10/297 ,3 71
detailed, relevant identifying characteristics" Id. (citing Synopsis of
Application of Written Description Guidelines at 60).
Similarly, in Noelle, the Federal Circuit, following Enzo II, held that:
"as long as an applicant has disclosed a ''fully characterized antigen, either
by its structure, formula, chemical name, or physical properties, or by
depositing the protein in a public depository, the applicant can then claim an
antibody by its binding affinity to that described antigen." Noelle, 355 F.3d
at 1349 (emphasis in original).
In the instant appeal, Appellants attempt to functionally claim an
immunoglobulin, or an antigen binding portion thereof, by claiming that it
"has the same antigenic specificity of an immunoglobulin produced by the
hybridoma having ATCC Accession Number PTA-3507," as recited in claim
91. However, Appellants have not, in their Specification, characterized the
purported ischemic-specific antigen to which either the claimed
immunoglobulin, or the immunoglobulin produced by the PTA-3507
hybridoma have the same affinity. Essentially, Appellants are attempting to
functionally claim an antibody to an uncharacterized antigen by saying the
antibody has the same affinity as another antibody to the same
uncharacterized antigen. That does not suffice to provide written descriptive
support.
Nor does Appellants' Specification provide any other written
description of the antibody. Appellants' Specification recites:
In another aspect, the invention features, a method for
isolating an ischemia-specific antigen, comprising providing a
pathogenic immunoglobulin, e.g., a pathogenic IgM, e.g., a
pathogenic IgM described herein, contacting a sample containing
the ischemia-specific antigen, e.g., a biochemical isolate (e.g., an
endothelia cell isolate), or a collection of proteins (e.g., an
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Application 10/297 ,3 71
expression library) with the pathogenic immunoglobulin under
conditions that allow specific binding of the pathogenic
immunoglobulin to the sample, detecting any changes in the level
of binding of the pathogenic antibody to the sample relative to a
control, wherein a change in the level of binding of the
pathogenic immunoglobulin in the presence of the sample
relative to that detected in the control is indicative of specific
binding, and isolating, e.g., purifying, the ischemia-specific
antigen from the sample. In a preferred embodiment, the sample
is enriched in the ischemia-specific antigen, e.g., it is obtained
from a subject (e.g., a human patient) with reperfusion or
ischemic injury. In other embodiments, the sample is a
biochemical isolate, e.g., an endothelial tissue, or an expression
library, e.g., a library derived from an endothelial tissue. In a
preferred embodiment, the contacting step occurs in vitro.
Spec. 8, 11. 1-15. Appellants' Specification thus describes methods by
which a person of ordinary skill in the art could isolate an ischemia-specific
antigen, but the Specification nowhere characterizes the ischemia-specific
antigen itself, nor gives specific examples of the isolation of such antigen.
And because there is no characterization or description of the ischemia-
specific antigen in Appellants' Specification, Appellants' functional
description of the immunoglobulin purporting to bind to the antigen does not
provide the requisite support demonstrating that Appellants were in
possession of the invention at the time of filing.
We consequently agree with the Examiner's primafacie conclusion
that Appellants' Specification fails to meet the written description
requirement of claim 91, and we affirm the rejection of claim 91 and
dependent claims 92-94.
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CONCLUSION
For the reasons set forth supra, we agree with the Examiner's
reasoning that claims 91-94 are prima facie unpatentable for failure to
provide a written description. We consequently affirm the rejection of the
claims.
DECISION
The Examiner's rejection of claims 91-94 as unpatentable under 35
U.S.C. § 112, first paragraph 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 ). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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