Ex Parte GOLDENBERG et al

Patent Trial and Appeal Board

Dec 7, 2018

13442504 (P.T.A.B. Dec. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/442,504 04/09/2012
37013 7590 12/11/2018
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
FIRST NAMED INVENTOR
David M. GOLDENBERG
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.
IMMU-0016US5 8921
EXAMINER
ROONEY, NORA MAUREEN
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
12/11/2018 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 and HANS J. HANSEN
Appeal 2017-011448
Application 13/442,504 1
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JAMES A. WORTH, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 2
1 Appellants identify "Immunomedics, Inc." as the real party in interest
(Appellants' May 24, 2017 Appeal Brief ("App. Br.") 2).
2 Appellants assert that the present Application is related to Application
11/296,432 (US 8,420,783, issued March 27, 2015) and 13/678,832 (App.
Br. 2, pending). Application 11/296,432 was the subject of Appeal 2011-
009765 (Decision affirming a rejection under 35 U.S.C. § 102(a) and (e)
entered September 19, 2012). Application 13/678,832 was the subject of
Appeal 2016-007109 (Decision affirming rejections under 35 U.S.C.
§ 103(a) entered June 21, 2017; Decision on Request for Rehearing
reversing the rejections of record entered November 6, 2017).
Appeal 2017-011448
Application 13/442,504
This Appeal under 35 U.S.C. § 134(a) involves claims 19-23, 25, 27,
29, 31, 33, 35, 37, and 44 (see Final Act. 3 1 and 2; see generally App. Br. 3:
§ (IV)(A)). 4 Examiner entered a rejection under the written description
provision of 35 U.S.C. § 112(a). We have jurisdiction under 35 U.S.C.
§ 6(b).
We enter a new ground of rejection under 35 U.S.C. § 112(b) and
AFFIRM the rejection of record. However, because our rationale differs
from Examiner's, we designate our affirmance a new ground of rejection.
3 Examiner's August 24, 2016 Final Office Action.
4 We note that Examiner and Appellants have introduced some ambiguity
into this record regarding the status of Appellants' claim 45 (see Final Act. 1
and 2: ,r 3 (Examiner's reference to claims "44-44"); see also id. at 3: ,r 8
("Claims 19-23 ... and 44-4 stand rejected" (emphasis added)); App. Br. 3:
§ (IV)(A) (Appellants' reference to a rejection of, inter alia, claim "45"). In
this regard, we note that Appellants previously entered a paper into this
record asserting both: (a) "[c]laim 45 has been amended" and (b) "[c]laim
45 has been canceled" (see Appellants' May 12, 2016 Amendment and
Request for Reconsideration in Response to Notice of Non-Compliant
Response 4). Nonetheless, Appellants' May 12, 2016 "Listing of the
Claims:" designates Appellants' claim 45 as "canceled" and the "CLAIMS
APPENDIX" of Appellants' Brief does not list claim 45 (see App. Br. 15).
Therefore, we find that Appellants' claim 45 stands canceled on this record
and will not be further addressed.
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Application 13/442,504
STATEMENT OF THE CASE
Appellants' disclosure "relates generally to methods and compositions
for immunotherapy of inflammatory and immune-dysregulatory diseases,
using multispecific antagonists that target at least two different markers"
(Goldenberg5 ,r 3). 6
Claims 19--23 are representative and reproduced below:
19. A method of treating sepsis or septic shock, comprising
administering to a patient that has been diagnosed with sepsis
or septic shock a therapeutic composition comprising a
therapeutically effective amount of a multispecific antagonist
that reacts specifically with a first target which is MIF and a
second target which is selected from the group consisting of
HMGB-1, TNF-a, IL-I, IL-6, MCP-19, RANTES, MIP-1 A,
MIP-1 B, IL-6R IL-I3R, IL-I5R, TF, thrombin, C3, CS, C3a,
C5a, CD46, CD55, CD59 and mCRP, the therapeutic
composition additionally comprising an anti-CD74 antibody as
a further therapeutic agent.
(App. Br. 14 (emphasis added).)
(Id.)
(Id.)
20. A method according to claim 19, wherein said
multispecific antagonist is a combination of two separate
antibodies.
21. A method according to claim 19, wherein said
multispecific antagonist is a multispecific antibody.
5 Goldenberg et al., US 2012/0230953 Al, published Sept. 13, 2012.
6 According to Appellants, both Examiner and Appellants reference to the
published version of Application 11/296,432 from which the Application on
Appeal is a divisional (see App. Br. 4, n. 1; see also Goldenberg "Related
U.S. Application Data"). We elect to refer to Goldenberg, which is the
published version of the Application before this Panel on Appeal.
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Application 13/442,504
(Id.)
(Id.)
22. A method according to claim 19, wherein said
multispecific antagonist is a fusion protein.
23. A method according to claim 19, wherein said
multispecific antagonist comprises a therapeutic agent.
Grounds of rejection before this Panel for review:
Claims 19--23, 25, 27, 29, 31, 33, 35, 37, and 44 stand rejected under
the written description provision of 35 U.S.C. § 112(a).
FACTUAL FINDINGS (FF)
FF 1. Appellants define the term "antibody" as encompassing "naked
antibodies and conjugated antibodies and antibody fragments, which may be
monospecific or multispecific. It includes recombinant antibodies, such as
chimeric antibodies, humanized antibodies and fusion proteins" (Goldenberg
FF 2. Appellants define the term "naked antibody" as "an antibody which
is not conjugated with a therapeutic agent. Naked antibodies include both
polyclonal and monoclonal antibodies, as well as certain recombinant
antibodies, such as chimeric and humanized antibodies" (Id. ,r 82).
FF 3. Appellants define the term "conjugated antibody" as "an antibody or
antibody fragment that is conjugated to a diagnostic or therapeutic agent"
(Id. ,I 83).
FF 4. Appellants define the term "multispecific antibody" as
an antibody which can bind simultaneously to at least two
targets which are of different structure, e.g., two different
antigens, two different epitopes on the same antigen, or a
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Application 13/442,504
hapten and/or an antigen or epitope. Two or more of the
binding arms may be directed to the same or different epitopes
of the same antigen, thus constituting multi valency in addition
to multispecificity.
(Id. ,r 84; see also id. ,r 38.)
FF 5. Appellants define the term "fusion protein" as
a recombinantly produced antigen-binding molecule in which
two or more different single-chain antibody or antibody
fragment segments with the same or different specificities are
linked. A variety of bispecific fusion proteins can be produced
using molecular engineering. In one form, the bispecific fusion
protein is monovalent, consisting of, for example, a scFv with a
single binding site for one antigen and a Fab fragment with a
single binding site for a second antigen. In another form, the
bispecific fusion protein is divalent, consisting of, for example,
an IgG with two binding sites for one antigen and two scFv
with two binding sites for a second antigen.
(Id. ,I 86.)
FF 6. Appellants define the term "therapeutic agent" as
a molecule or atom, which is conjugated to an antibody moiety
to produce a conjugate which is useful for therapy. These can
be active when given unconjugated to an antibody, such as with
131I in thyroid neoplasms, and various cytotoxic drugs in cancer,
autoimmune diseases, graft versus host disease, and in the
immunosuppression induced for organ transplantation, etc.
Examples of therapeutic agents include a therapeutic
radionuclide, a boron compound, an immunomodulator, a
hormone, a hormone antagonist, an enzyme, oligonucleotides,
an enzyme inhibitor, a photoactive therapeutic agent, a
cytotoxic agent, and an angiogenesis inhibitor, and a
combination thereof, and these are described in US Published
Application no. 2004 0057902. Preferred therapeutic
radioisotopes include beta, alpha, and Auger emitters, with a
ke V range of 80-500 ke V. Exemplary therapeutic radioisotopes
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include 22s Ac 1nLu 19s Au 32p 12s1 1311 9oy 1s6Re 1ssRe 67Cu
' ' ' ' ' ' ' ' ' ' 67Ga, 1111n, and 211At.
(Id. ,r 80; see also id. ,r,r 92-99.)
FF 7. Appellants disclose:
The multispecific antagonist may be an immunoconjugate that
comprises a therapeutic agent, such as a radionuclide, an
immunomodulator, a hormone, a hormone antagonist, an
enzyme, an enzyme inhibitor, oligonucleotide, a photoactive
therapeutic agent, a cytotoxic agent, an antibody, an
angiogenesis inhibitor, and a combination thereof. When the
therapeutic agent is an oligonucleotide it may be an antisense
oligonucleotide.
(Id. ,r 48 (emphasis added).)
FF 8. Appellants disclose
[ w ]hen the multispecific antagonist comprises a single
multispecific antibody, then CD74 is excluded as a target of
said antagonist. Furthermore, when the multispecific antagonist
comprises a combination of separate antibodies, combinations
are excluded where one of the components targets a B-cell
antigen, and the other component targets a T-cell, plasma cell,
macrophage or inflammatory cytokine.
(Id. ,I 91.)
DEFINITENESS:
NEW GROUND OF REJECTION
The following is a quotation of 35 U.S.C. § 112(b ):
(B) CONCLUSION.-The specification shall conclude with
one or more claims particularly pointing out and distinctly
claiming the subject matter which the inventor or a joint
inventor regards as the invention.
Claims 19-23, 25, 27, 29, 31, 33, 35, 37, and 44 are rejected under
35 U.S.C. § 112(b) as being indefinite for failing to particularly point out
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and distinctly claim the subject matter which the inventor or a joint inventor,
or for pre-AIA the applicant regards as the invention.
ANALYSIS
Appellants' claim 19 is the only independent claim of record (see
App. Br. 14--15). Appellants' claims 20-23, 25, 27, 29, 31, 33, 35, 37, and
44 depend directly or indirectly from Appellants' claim 19 (id.).
Appellants' claims 19--23 are reproduced above.
The only reference to a "therapeutic agent" in Appellants' claim 19
appears in the last clause of the claim, which requires the "therapeutic
composition" to include an anti-CD74 antibody "as a further therapeutic
agent" (see App. Br. 14 (emphasis added)). In this regard, we note that
Appellants' claim 23 depends from and further limits the multispecific
antagonist of Appellants' claim 19 to comprise "a therapeutic agent" (see
id.). Thus, we find no antecedent basis in Appellants' claim 19 for afurther
therapeutic agent (see id.).
In addition, we note that Appellants claims 20-22 depend from and
limit the multispecific antagonist of Appellants' claim 19 to "two separate
antibodies," "a multispecific antibody," or a "fusion protein," respectively
(see id.; see also FF 1-5). Appellants define the term "fusion protein" as "a
recombinantly produced antigen-binding molecule in which two or more
different single-chain antibody or antibody fragment segments with the same
or different specificities are linked" (FF 5). Thus, the multispecific
antagonist of Appellants' claim 19 may be an antibody.
Appellants' definition of the term "therapeutic agent" does not include
an antibody (see FF 6). Thus, it is unclear whether Appellants intend for the
anti-CD74 antibody to: (a) represent a therapeutic agent, which is
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inconsistent with Appellants' definition of the term therapeutic agent or (b)
comprise a therapeutic agent (see App. Br. 14; cf FF 6).
We recognize, however, that Appellants' Specification discloses:
The multispecific antagonist may be an immunoconjugate that
comprises a therapeutic agent, such as a radionuclide, an
immunomodulator, a hormone, a hormone antagonist, an
enzyme, an enzyme inhibitor, oligonucleotide, a photoactive
therapeutic agent, a cytotoxic agent, an antibody, an
angiogenesis inhibitor, and a combination thereof. When the
therapeutic agent is an oligonucleotide it may be an antisense
oligonucleotide.
(FF 7) and defines the term "conjugated antibody" as "an antibody or
antibody fragment that is conjugated to a diagnostic or therapeutic agent"
(FF 3). Thus, based on Appellants' disclosure it is unclear whether a
multispecific antagonist that is an immunoconjugate: (a) is a therapeutic
agent, as expressly defined by Appellants, e.g., 32P, conjugated to an
antibody, or (b) if the scope of Appellants' definition of therapeutic agent is
broadened to further include an antibody, then the immunoconjugate is an
antibody therapeutic agent conjugated to some other reagent, i.e. another
antibody, thereby producing a multispecific antibody (see e.g., FF 3, 6, and
7). Stated differently, Appellants' claim 19 uses the term "therapeutic
agent" in a manner that is inconsistent with how that term is defined in
Appellants' Specification.
As discussed above, Appellants' claim 21 requires that the
multispecific antagonist of Appellants' claim 19 is a multispecific antibody
(App. Br. 14). According to Appellants' definitions, a "multispecific
antibody" "can bind simultaneously to at least two targets which are of
different structure, e.g., two different antigens, two different epitopes on the
same antigen, or a hapten and/or an antigen or epitope" (FF 4). Thus, when
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Application 13/442,504
read in light of Appellants' Specification, it is unclear from the language of
Appellants' claim 19 whether Appellants intend for the anti-CD7 4 antibody
to be part of a multispecific antibody (see App. Br. 14). If so, it would
appear that Appellants' disclosure expressly excludes such a construct (see
FF 8).
Thus, when read in light of Appellants' Specification, the scope of
Appellants' claims is indefinite.
CONCLUSION
The preponderance of evidence supports a conclusion that the phrase
"additionally comprising an anti-CD74 antibody as a further therapeutic
agent," as set forth in Appellants' claim 19, is indefinite and lacks
antecedent basis. Thus, Appellants' independent claim 19 stands rejected
under 35 U.S.C. § 112(b). Because Appellants' claims 20-23, 25, 27, 29,
31, 3 3, 3 5, 3 7, and 44 depend directly or indirectly from Appellants' claim
19 they too stand rejected under 35 U.S.C. § 112(b).
Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Appellants' Specification fails to provide written
descriptive support for the claimed invention?
ANALYSIS
We incorporate our findings and analysis set forth above with respect
to the rejection under 35 U.S.C. § 112(b) herein.
We find no error in Examiner's findings that Appellants'
Specification "does not appear to provide an adequate written description of
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a method 'additionally comprising an anti-CD74 antibody as a further
therapeutic agent"' (Final Act. 4; see Ans. 3; FF 1-9) or that although
Appellants'
[S]pecification provides support for anti-CD74 being a single
specific antibody of a multispecific antagonist comprising
single specific antibodies ... , it does not provide support for
single specific anti-CD74 antibodies to be administered with a
multispecific antagonist that is a multispecific antibody.
(Final Act. 7; see Ans. 6; FF 9.)
Although Appellants assert that "CD7 4 is an important target for
sepsis," Appellants do not identify a disclosure in their Specification of an
anti-CD7 4 antibody that is a "therapeutic agent" (see App. Br. 11 ). As noted
above Appellants' Specification, i.e. Goldenberg, defines a "therapeutic
agent" as a molecule or atom, which is conjugated to an antibody moiety to
produce a conjugate that is useful for therapy (FF 6). Because it is not
conjugated to an antibody, the anti-CD74 antibody recited in claim 19 is not
a "therapeutic agent" as that term is defined in Appellants' Specification.
Appellants do not persuade us, therefore, that their Specification provides
descriptive support for the recitation in claim 19 of a "therapeutic agent"
wherein that therapeutic agent is an anti-CD74 antibody.
We are not persuaded by Appellants' contention that their
Specification "clearly informs and directs the knowledgeable reader to the
use of separate secondary therapeutics in addition to a multispecific
antagonist, and that these secondary therapeutics may be further antibodies"
(App. Br. 11 (citing Goldenberg ,r 44)).
Goldenberg, as relied upon by Appellants, discloses that "[t]he
multispecific antagonist may comprise a single active component, or it may
comprise multiple active components. The embodiment comprising a single
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Application 13/442,504
active component does not encompass mixtures of antibodies, which would
by definition comprise two or more active components" ( Goldenberg ,r 44
(emphasis added)). Thus, notwithstanding Appellants' contention to the
contrary, Goldenberg, as relied upon by Appellants, informs and directs the
knowledgeable reader to an understanding that, by definition, antibodies are
active components (see id.). Goldenberg, as relied upon by Appellants,
further discloses that "[ m ]ultispecific antagonists comprising more than one
active component[, i.e. by definition, more than one antibody,] also may
include secondary therapeutics that affect a component of the innate
immune system, a component of the adaptive immune system, coagulation,
infectious agents or cancer cells" (id.). Thus, notwithstanding Appellants'
contention to the contrary, Goldenberg, as relied upon by Appellants,
informs and directs the knowledgeable reader to an understanding that, by
definition, secondary therapeutics, are something other than an active
component, i.e. an antibody (see id.).
As discussed above, Goldenberg, as relied upon by Appellants,
discloses that a multispecific antagonist may comprise multiple active
components, i.e. multiple antibodies (id.). We are not persuaded, however,
by Appellants' contention that Goldenberg, as relied upon by Appellants,
discloses "multiple active components can encompass a mixture of
antibodies, such as a multispecific with another antibody as is recited in
[Appellants'] claim 19" (App. Br. 12). Notwithstanding Appellants'
contention to the contrary, Goldenberg, as relied upon by Appellants, makes
clear that "a single active component[, i.e. a multispecific antibody,] does
not encompass mixtures of antibodies, which would by definition comprise
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two or more active components" (Goldenberg ,r 44 (emphasis added); see
also FF 4).
For the foregoing reasons, we are not persuaded by Appellants'
contention that "anti-CD7 4 antibody must be a separate antibody in an
embodiment which includes a multispecific antibody, as in claim 19" (App.
Br. 12). As discussed above, notwithstanding Appellants' contention to the
contrary, a multispecific antibody is a single antibody, i.e., a single active
component (FF 4; see also Goldenberg ,r 44). Thus, Appellants' contention
would require that a single active component, i.e. multispecific antibody, is
mixed with an anti-CD74 antibody (see App. Br. 12). Goldenberg, as relied
upon by Appellants, expressly excludes such an interpretation of Appellants'
claim 19, wherein Goldenberg discloses that "a single active component
does not encompass mixtures of antibodies" ( Goldenberg ,r 44 ( emphasis
added); cf App. Br. 12; Reply Br. 3 ("a separate anti-CD74 antibody as part
of [Appellants'] therapeutic composition is unambiguously described. That
separate anti-CD74 may be combined ... with another multispecific
antibody (which cannot include an anti-CD74 antibody as per [Appellants']
proviso")).
In the alternative, we recognize that although Appellants' reference to
"a mixture of antibodies, such as a multispecific with another antibody," and
corresponding arguments, infers a multispecific antibody, it may,
nonetheless, have been Appellants' intention to refer to a multispecific
antagonist (see App. Br. 12 (emphasis added); cf FF 4 and 7). In this
context, notwithstanding Goldenberg's definition of a therapeutic agent (see
FF 6), as discussed above with respect to the rejection under 35 U.S.C.
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§ 112(b ), Goldenberg appears to disclose that a multispecific antagonist may
be an immunoconjugate that comprises an antibody, wherein the antibody is
a therapeutic agent (FF 3 and 7). In this context, Appellants may be
inferring that their claim 19 encompasses a mixture of antibodies, wherein at
least one such antibody is an immunoconjugate, wherein the antibody is
conjugated to an anti-CD74 antibody (see App. Br. 12; see also FF 3 and 7).
Such an immunoconjugate would encompass multispecific antibodies. If
this was Appellants' intent when referring to a multispecific, we note, as
Appellants recognize, that Goldenberg expressly excludes such a construct
(see FF 8; cf App. Br. 12; see Reply Br. 7 2-3 8).
For the foregoing reasons, we are not persuaded by Appellants'
contention that "an embodiment comprising multiple active components can
encompass a mixture of antibodies, such as a multispecific with another
antibody as is recited in [Appellants'] claim 19" and "[t]he knowledgeable
reader would readily recognize that [Appellants] envisioned, i.e., possessed,
that this other antibody could be an anti-CD74 antibody, since CD74 is
clearly described in [Appellants'] [S]pecification as being useful in the
treatment of sepsis" (App. Br. 12; Reply Br. 5).
For the foregoing reasons, we are not persuaded by Appellants'
contention that Appellants' "elected invention of MIF and HMBG-1 as a
multispecific antagonist, and anti-CD74 antibody as a secondary therapeutic
is entirely appropriate and specifically supported by [their] disclosure" (App.
Br. 12; see also Reply Br. 5).
7 Appellants' September 11, 2017 Reply Brief.
8 The Reply Brief is not paginated. Therefore, all reference to page numbers
of the Reply Brief refer to page numbers as if the Reply Brief was number
consecutively beginning with the first page.
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CONCLUSION
The preponderance of evidence on this record supports Examiner's
finding that Appellants' Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 19 under the
written description provision of 35 U.S.C. § 112, first paragraph is affirmed.
Claims 20-23, 25, 27, 29, 31, 33, 35, 37, and 44 are not separately argued
and fall with claim 19. Because our rationale differs from Examiner's we
designate this affirmance a new ground of rejection.
TIME PERIOD FOR RESPONSE
This Decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 4I.50(b) provides "[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review."
37 C.F.R. § 4I.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner ....
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record ....
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED; 37 C.F.R. 4I.50(b)
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