Ex Parte GOLDENBERG et al

Patent Trial and Appeal Board

Feb 10, 2017

13402480 (P.T.A.B. Feb. 10, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/402,480 02/22/2012 David M. GOLDENBERG IMMU-0020US3 6273
37013 7590 02/14/2017
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
EXAMINER
HUYNH, PHUONG N
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
02/14/2017 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):
mail@rkmllp.com
EOfficeAction@rkmllp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID M. GOLDENBERG, HANS J. HANSEN,
CHIEN-HSING KEN CHANG, SAILAJA S. VANAMA, and
EDMUND A. ROSSI1
Appeal 2016-002936
Application 13/402,480
Technology Center 1600
Before FRANCISCO C. PRATS, ROBERT A. POLLOCK, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1, 3, 4, and 7—10. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
According to the Specification, the non-mammalian cytotoxic
ribonuclease, ranpimase, can be isolated from Rana pipiens oocytes and
early embryos, and can also be expressed recombinantly. Spec., 2, 7.
1 Appellants identify the real party-in-interest as Immunomedics, Inc. App.
Br. 2.
Appeal 2016-002936
Application 13/402,480
“[RJanpirnase displays a predictable, dose-dependent and reversible
toxicity” in animal studies, as well as anti-tumor activity in animal and
clinical trials. Id. at || 4—5.
The Specification discloses fusion proteins comprising a
recombinantly-produced ranpimase, or a conservative variant thereof, and a
targeting moiety comprising immunoglobulins or fragments thereof. See
generally, id. at || 2, 9, 66—73, 80, 84. The “targeting moiety can be used to
specifically deliver an attached molecule to a given cell type, by
preferentially associating with the marker associated with that cell type.” Id.
at 80. Accordingly, the Specification provides
an immunotoxin comprising (a) a fusion polypeptide, where
the fusion protein contains a non-mammalian cytotoxic
ribonuclease fused to a first immunoglobulin variable
domain and (b) a second polypeptide comprising a second
immunoglobulin variable domain, where one of the immune
globulin variable domains is a light chain variable domain
and the other immunoglobulin variable domain is a heavy
chain variable domain, where the first and second
immunoglobulin variable domains together form an antigen
binding site ....
Id. at 19.
The Specification discloses that the antigen binding site may be
directed against a wide variety of target antigens including tumor antigens,
B-cell antigens, T-cell antigens, plasma antigens, HLA antigens, and
antigens associated with autoimmune diseases, infection, inflammation, and
infectious diseases. See, e.g., id. at || 25—87. As noted by the Examiner,
the Specification further discloses four exemplary immunotoxins comprising
ranpimase with immunoglobulin variable domains comprising antibody
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Application 13/402,480
CDRs (complementarity determining regions) that specifically bind to
protein antigens CD22, EGP-1, CD74, and CEA. See Ans. 3^4.
Claim 1, the sole independent claim before us recites (emphasis
added):
1. An immunotoxin comprising:
(a) a first fusion polypeptide, wherein said fusion
polypeptide comprises a nonmammalian ribonuclease fused to
a first immunoglobulin variable domain and
(b) a second polypeptide comprising a second
immunoglobulin variable domain, wherein said first and
second immunoglobulin variable domains comprise the CDRs
of the immunoglobulin heavy and light chain of an antibody
which together form an antigen binding site
wherein said non-mammalian ribonuclease is fused to the
N-terminus of said first immunoglobulin variable domain,
wherein said non-mammalian ribonuclease bears an N-
terminal pyroglutamate residue, and wherein the first
immunoglobulin variable domain is a light chain variable
domain
wherein said non-mammalian ribonuclease is ranpimase or
a conservatively modified variant thereof and wherein the
immunotoxin is glycosylated.
Dependent claim 4 further limits claim 1 to antibodies which “bind[]
to an antigen selected from the group consisting of CD22, EGP-1, CD74,
and CEA.”
ANALYSIS
Claims 1,3,4, and 7—10 stand rejected under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the
written description requirement and for lack of enablement. Appellants
oppose. App. Br. 5—14; Reply Br. 1—3.
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Written Description
“To satisfy [the written description] requirement, the specification
must describe the invention in sufficient detail so ‘that one skilled in the art
can clearly conclude that the inventor invented the claimed invention as of
the filing date sought.”’ In re Alonzo, 545 F.3d, 1015, 1019 (Fed. Cir.
2008), citing Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed.
Cir. 1997). The written description must be of sufficient detail to show
possession of the full scope of the invention. Pandrol USA, LP v. Airboss
Ry. Prods., Inc., 424 F.3d 1161, 1165 (Fed. Cir. 2005). However, “[i]t is not
necessary that every permutation within a generally operable invention be
effective in order for an inventor to obtain a generic claim, provided that the
effect is sufficiently demonstrated to characterize a generic invention.”
Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
In setting forth the written description rejection, the Examiner states
that
only an immunotoxin comprising (a) a first fusion polypeptide,
wherein said fusion polypeptide comprises ranpimase or a
conservatively modified variant thereof fused to a first light
chain immunoglobulin variable domain and (b) a second
polypeptide comprising a second immunoglobulin variable
domain, wherein said first light chain immunoglobulin variable
domain and the second heavy chain immunoglobulin variable
domains of an antibody which together form an antigen binding
site of an antibody that binds to an antigen selected from the
group consisting of CD22, EGP-1, CD74 and CEA and wherein
the antibody is selected from the group consisting of hLL2, hR7,
hLLl and hMN14 and wherein said non-mammalian
ribonuclease is fused to the N-terminus of said first
immunoglobulin variable domain, wherein said non-mammalian
ribonuclease bears an N-terminal pyroglutamate residue, and
wherein the first immunoglobulin variable domain is a light
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Application 13/402,480
chain variable domain, but not the full breadth of the claims
meets the written description provision of 35 U.S.C. § 112,
first paragraph.
Ans. 6—7. In particular, the Examiner states that
the specification does not describe with any particularity, the
identifying structural and/or functional features shared by
members of the genus of first and second immunoglobulin
variable domains encompassed by the claims. One cannot
predict what structure is common to all “CDRs of the first and
second immunoglobulin variable domains” that bind to the same
antigen, i.e., CD22, EGP-1, CD74 or CEA, let alone different
antigen or unspecified antigen.
Id. at 4.
We note that the Specification recites an extensive array of target
antigens to which the CDRs of the claimed invention may be directed. See,
e.g., Spec. H25—87. As noted by Appellants, many antibodies (and, thus,
operative CDRs) within the claimed genus are known in the art, and others
may be generated by conventional methods. See App. Br. at 7, 10-13.
Accordingly, we agree with Appellants that the written description
requirement does not require that CDRs specific to those antigens be listed
in the Specification by name. See App. Br. 7.
We also agree with Appellants’ argument that the written description
requirement does not require the degree of structural similarity that the
Examiner requires because the claimed CDRs perform a targeting function
directed to a highly diverse group of antigens. Thus,
[a]ll of these [antibodies] have different structures, i.e., they do
not “share a common structure.” That is why they bind to
different antigens. However, they are known and characterized
in the art, and useful immunotoxins according to the present
invention can be made with any of them. Their differing
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Application 13/402,480
structures will not affect their ability to be formulated as
immunotoxins with a ribonuclease as presently claimed.
The examiner refers to the need for “structural features common
to the members of the genus.” The hallmark of the antibody —
antigen interaction is specificity, and specificity results from the
fact that there is a difference in structure. If the various
antibodies had common structural features, they would not bind
specifically to their cognate antigen. Therefore, the examiner is
requiring applicant to show something that is antithetical to the
function of the present invention. The antibodies possess a
commonality of function in that they all bind to a cognate
antigen. But they will not possess a commonality of structure.
Reply Br. 2—3 (emphasis omitted).2
In sum, we agree with Appellants that the Specification,
clearly provides a representative number of species and
unambiguously informs the reader that the scope of the invention
extends to immunotoxins other than [those] which are
exemplified in the examples, i.e., applicant has “convey[ed] with
reasonable clarity to those skilled in the art that, as of the filing
date sought, he or she was in possession of the invention,”
thereby satisfying written description.
Id.; see also, Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir.
2006) (holding that “where, as in this case, accessible literature sources
clearly provided, as of the relevant date, genes and their nucleotide
sequences (here ‘essential genes’), satisfaction of the written description
requirement does not require either the recitation or incorporation by
reference (where permitted) of such genes and sequences”).
2 The Reply Brief does not include page numbers. We cite to the Reply
Brief as if the first page were page 1, and the remaining pages numbered
consecutively.
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Enablement
“[A] specification disclosure which contains a teaching of the manner
and process of making and using the invention in terms which correspond in
scope to those used in describing and defining the subject matter sought to
be patented must be taken as in compliance with the enabling requirement of
the first paragraph of § 112 unless there is reason to doubt the objective truth
of the statements contained therein which must be relied on for enabling
support.” In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971) (emphasis in
original). When rejecting a claim under the enablement requirement of
Section 112, the Examiner bears an initial burden of setting forth a
reasonable explanation as to why she believes that the scope of the claim is
not adequately enabled by the description of the invention provided in the
specification of the application. In re Wright, 999 F.2d 1557, 1561—62 (Fed.
Cir. 1993). It is “irrelevant whether this teaching is provided through broad
terminology or illustrative examples.” Id. “The fact that some
experimentation is necessary does not preclude enablement: what is required
is that the amount of experimentation ‘must not be unduly extensive.’” PPG
Indus. Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996)
(quoting Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d
1569, 1576 (Fed. Cir. 1984)). “The key word is ‘undue,’ not
‘experimentation.’” In re Angstadt, 537 F.2d498, 504 (CCPA 1976).
As with the written description rejection, the Examiner focuses on the
antibody portion of the claimed immunotoxin as the basis for the enablement
rejection, stating:
In view of Applicants’ disclosure, it is apparent that one
cannot predict which undisclosed first immunoglobulin variable
domain paired with which second immunoglobulin variable
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Application 13/402,480
domain for binding to which antigen or epitope for the claimed
immunotoxin to treat cancer or autoimmune diseases. One of
skill in the art would be subject to undue and unreasonable
experimentation to make and use the “immunotoxin” reasonably
commensurate in scope with the claims.
Ans. 10. Contrary to the Examiner’s statement, we do not read the instant
claims as requiring that the immunotoxins “treat cancer or autoimmune
disease.” Nor does the Examiner establish that it would require undue
experimentation for one of ordinary skill in the art to construct
immunotoxins using CDRs within the broad scope of the claimed genus.
See Reply Br. 2 (“The methodology for making immunotoxins from the
antibodies is well within the level of skill in the art, and the difference in
structure of the antibodies does not mean that a skilled artisan could not
envision and make an immunotoxin from any of them.”). Accordingly, the
Examiner has not shown that the invention as claimed fails to satisfy the
enablement requirement.
SUMMARY
I. We reverse the rejection of claims 1,3,4, and 7—10 under 35 U.S.C.
§ 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to
comply with the written description requirement.
II. We reverse the rejection of claims 1,3,4, and 7—10 under 35 U.S.C.
§ 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, for lack of
enablement.
REVERSED
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