Ex Parte Mudde et al

Patent Trial and Appeal Board

Jun 24, 2016

12281504 (P.T.A.B. Jun. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/281,504 09/03/2008
94694 7590
LOZA & LOZA LLP
Michael Fedrick, Esq.
305 North Second Ave., #127
Upland, CA 91786
06/28/2016
FIRST NAMED INVENTOR
GeertMudde
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.
REDL-1202 6960
EXAMINER
ROONEY, NORA MAUREEN
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
06/28/2016 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):
mike-pto@lozaip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEER T MUD DE and GOTTFRIED HIMMLER 1
Appeal2014-001852
Application 12/281,504
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for performing active immunotherapy or treating allergies. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is S-T ARget therapeutics
GmbH. (Br. 2.)
Appeal2014-001852
Application 12/281,504
STATEMENT OF THE CASE
Background
"The invention provides a molecule or molecule complex being
capable of binding to toll-like receptor 9 (TLR9) and Fe gamma receptor RII
(CD32) and including at least one epitope of at least one antigen." (Spec. 6,
11. 3-5.)
Claims on Appeal
Claims 22, 23, and 31-33 are on appeal. (Claims Appendix, Br. 14--
19.) Independent claim 22 is illustrative and reads as follows:
22. A method for performing active immunotherapy for an
allergic disease, comprising the step of administering to a patient a
prophylactically or therapeutically effective amount of at least one molecule
or molecule complex comprising a TLR9 binding region capable of binding
to TLR9, a CD32 binding region capable of binding to CD32, and at least
one epitope of at least one antigen.
Examiner's Rejection
Claims 22, 23, and 31-33 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
(Ans. 3.)
Claims 22, 23, and 31-33 were not separately argued, and we
therefore limit our discussion to claim 22.
FINDINGS OF FACT
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
FF 1. The Examiner finds that Appellants are in possession of "the
molecular complexes encoded by SEQ ID NOs 63 and 64." (Ans. 3.)
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Application 12/281,504
FF 2. The Examiner finds that Appellants are not in possession of the
subject matter of claims 22, 23, and 31-33. (Id. at 3--4.)
FF 3. The Specification states that
"[i]n one embodiment of the invention the molecule or molecule
complex comprises at least three parts, one part being a structure
specifically binding to TLR9 ... another part being a structure
specifically binding to CD32 ... and at least one other part being
one or more T [cell] epitopes of an antigen and/or allergen. The
parts may be independent structures which are linked together
either by chemical linkages or by genetic fusion or by other (non-
covalent) interactions."
(Spec. 6, 11. 6-12.)
FF 4. The Specification discloses the "[fJinal expression vector
pHLA23EP.seq (SEQ ID No 64) containing TLR9 and CD32 binding
regions and epitope sequence (see SEQ ID No 16)." (Spec. 43--49.)
FF 5. The Examiner finds that "function, including binding activity, cannot
be predicted based on a protein's structure. Based on the unpredictability of
protein function in vivo, treating (therapeutically effective) and preventing
(prophylactically effective) allergic disease would also not be predictable."2
(Ans. 5.)
FF 6. The Examiner finds that "[t]he skilled artisan cannot envision all the
molecule complex possibilities recited in the instant claims." (Id. at 6.)
ISSUE
Whether the Specification's description shows that Appellants were in
possession of the method recited in claim 22.
2 The Examiner cites several references of record in support of this finding.
(Ans. 4--5.)
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Principles ofLaw
In evaluating compliance with the written description requirement,
"the test for sufficiency is whether the disclosure of the application relied
upon reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date." Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(citing cases).
When claims are drawn to a genus, "a sufficient description of [the]
genus ... requires the disclosure of either a representative number of species
falling within the scope of the genus or structural features common to the
members of the genus so that one of skill in the art can 'visualize or
recognize' the members of the genus." Id. at 1350 (quoting Regents of the
University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568---69 (Fed.
Cir. 1997) ). Moreover, when claims are drawn to a genus using functional
language to define a desired result, "the specification must demonstrate that
the applicant has made a generic invention that achieves the claimed result
and do so by showing that the applicant has invented species sufficient to
support a claim to the functionally-defined genus." Abb Vie Deutschland
GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir.
2014) (quotingAriad, 598 F.3d at 1349).
For purposes providing written description of a genus, "merely
drawing a fence around a perceived genus is not a description of the genus.
One needs to show that one has truly invented the genus, i.e., that one has
conceived and described sufficient representative species encompassing the
breadth of the genus. Otherwise, one has only a research plan, leaving it to
others to explore the unknown contours of the claimed genus. Id. at 1300.
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Analysis
The Examiner found that Appellants were not in possession of the
subject matter of claim 22. (FF 2.) In support of that finding, the Examiner
states
[Appellants have] only described the molecule complexes
encoded by SEQ ID NOs 63 and 64 in the specification. The
specification has not adequately described any "TLR9 binding
region capable of binding to TLR9 ," any CD32 binding regions
capable of binding to CD32" or any "antibody" for use in the
claimed invention. The specification has not described any
"epitope of at least one antigen," any "T cell epitope," or any
"epitope derived from an allergen."
(Ans. 4.)
The Examiner also points to the unpredictability of the claimed
invention (FF 5) and the inability of one skilled in the art to visualize the
members of the genus as claimed (FF 6).
Appellants argue that "[a] molecule according [to] the present
invention is described (SEQ ID N0:64)" and that "[t]he present application
discloses methods of making the present molecule. "3 (Br. 11, referencing
Example 6 at Spec. 31--49.) Appellants also assert that one of skill in the art
would not have found the present invention "unpredictable" based on a
statement in an Office Action regarding "a high expectation of success. "4
(Br. 11-12.)
3 Appellants apparently focus on SEQ ID NO. 64 because SEQ ID NO. 63 is
only for the expression vector containing TLR9 and CD32 binding regions.
(Spec. 38.)
4 Office Action dated December 21, 2011 ("Non-Final Act." 2-3).
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Appellants argue further that
With regard to molecules other than those encoded by SEQ ID
NOs 63 and 64, the specification describes in detail the relevant
functional and identifying characteristics of such molecules,
including not only their binding specificity (for TLR9, CD32,
and various isotopes) but also their structure and nature, i.e. the
molecules can be diabodies, single domain antibodies, intact
antibodies, fusion proteins, or a number of other types of
molecules.
(Br. 10, referencing Spec. 10.)
Appellants also contend that the "binding characteristics," the "functional
characteristics of binders," and the "correlation between the structure of the
present bispecific antibody ... and the function of the molecule in treating
allergies" are disclosed in the Specification. 5 (Id. at 11, referencing Spec. 3-
5.)
We find that the Examiner has the better position. We note at the
outset that claim 22 broadly claims a result (immunotherapy for an allergic
disease) based on a combination of structures (at least one molecule or
molecule complex) that have the functions, for example, of binding to TLR9
and CD32. (Br. 17.) Appellants' arguments are addressed below.
Appellants' arguments regarding the disclosure of a molecule
(encoded by SEQ ID NO. 64), and methods of making that molecule, are
unpersuasive. Possession of that molecule is not in dispute. (FF 1.)
However, that only constitutes the disclosure of one species of a large,
5 We also acknowledge, but are unpersuaded by, Appellants present tense
statements regarding structures or methods that are "known to those of skill
in the art" or molecules that are "commercially available." Sufficiency of
disclosure is evaluated as of the filing date. Ariad, 598 F.3d at 1351.
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unpredictable genus as recited in claim 22, and is thus insufficient in itself to
establish possession of the genus. See In re Curtis, 354 F.3d 1347, 1358
(Fed. Cir. 2004) ("a patentee will not be deemed to have invented species
sufficient to constitute the genus by virtue of having disclosed a single
species when, as is the case here, the evidence indicates ordinary artisans
could not predict the operability in the invention of any species other than
the one disclosed.") The description of only one molecule or species in the
present case simply does not satisfy the written description requirement.
Appellants' argument regarding predictability is also unpersuasive.
Appellants only support for that argument is a statement regarding "a high
expectation of success" made in an Office Action in the context of
obviousness. (Non-Final Act. 2-3.) However, a claimed invention may
well be obvious but still fail to satisfy the written description requirement.
See Ariad, 598 F.3d at 1352 ("a description that merely renders the invention
obvious does not satisfy the [written description] requirement").
Appellants' argument regarding the "functional and identifying
characteristics" of molecules "other than those encoded by SEQ ID NOs 63
and 64" is also unpersuasive. Indeed, while claim 22 recites a combination
of structures with the functional requirement of binding to TLR9 and CD32,
we find that the Specification similarly describes such "other" molecules as
essentially any molecules that are capable of binding to TLR9 and CD32.
(See, e.g., Spec. 3-5.) However, while in some cases a functional
description can satisfy the written description requirement, "such [a]
functional description can be sufficient only if there is also a structure-
function relationship known to those of ordinary skill in the art." In re
Wallach, 378 F.3d 1330, 1335 (Fed. Cir. 2004). Appellants have not offered
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persuasive evidence to overcome the Examiner's finding that such a
structure-function relationship was not known to those of ordinary skill in
the art. (See FF 5.) See AbbVie, 759 F.3d at 1301 ("Functionally defined
genus claims can be inherently vulnerable ... for lack of written description
support, especially in technology fields that are highly unpredictable, where
it is difficult to establish a correlation between structure and function for the
whole genus or to predict what would be covered by the functionally
claimed genus.").
Given the scope of the claimed method, we find that the Specification
provides, at most, a wish list or research plan, "leaving it to others to explore
the unknown contours of the claimed genus." AbbVie, at 1300; see also
Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351 (Fed.
Cir. 2011).
Conclusion
A preponderance of evidence of record supports the Examiner's
finding that Appellants' Specification fails to show that Appellants were in
possession of the method recited in claim 22. Claims 23 and 31-33 were not
argued separately and fall with claim 22.
Lack of Unity
Appellants request that the finding of a lack of unity, in the context of
a restriction requirement, be withdrawn. (Br. 10.) However, as stated by the
Examiner, Appellants "may file a petition for review of the restriction
requirement, but the matter is not appealable." (Ans. 3.) See In re
Hengehold, 440 F.2d 1395, 1398-1404 (CCPA 1971).
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SUMMARY
We affirm the rejection of all appealed claims.
TIME 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).
AFFIRMED
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