Ex Parte Goldenberg et al

Patent Trial and Appeal Board

Aug 16, 2016

13349755 (P.T.A.B. Aug. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/349,755 01/13/2012
37013 7590 08/18/2016
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-0005US6 1040
EXAMINER
SCHWADRON, RONALD B
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
08/18/2016 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):
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
Appeal2015-000434
Application 13/349,755
Technology Center 1600
Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for treating an autoimmune disorder in a subject having failed methotrexate
therapy. The Examiner rejected the claims as failing to comply with the
written description requirement, on the grounds of obviousness-type double
patenting, and as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We
affirm.
1 Appellants identify the Real Party in Interest as lmmunomedics,
Inc. (See App. Br. 2).
Appeal2015-000434
Application 13/349,755
Statement of the Case
Background
"[T]his invention is directed to methods for treating autoimmune
disorders by administering antibodies that bind to a B-cell antigen, such as
the CD22, CD20, CD19, and CD74 or HLA-DR antigen" (Spec. 1, 11. 15-
17).
The Claims
Claims 1, 13-15, 17, 23-25, 30, and 36-38 are on appeal. Claim 1 is
representative and reads as follows:
1. A method for treating an autoimmune disorder
comprising administering to a human subject having an
autoimmune disorder and having failed methotrexate therapy,
an effective amount of a murine, chimeric, or humanized anti-
CD22 LL2 antibody (ATCC Accession No. PTA-6735) or
antigen-binding fragment thereof.
Tlze Issites
A. The Examiner rejected claims 1, 13-15, 17, 23-25, 30, and 36-38
under 35 U.S.C. § 112(a) or§ 112, first paragraph as failing to comply with
the written description requirement (Final Act. 6).
B. The Examiner rejected claims 1, 13-15, 17, and 23-25 on the ground
of nonstatutory obviousness-type double patenting as being unpatentable
over claims 1--47 of Goldenberg '901 2 in view ofWolfe3 (Final Act. 3).
2 Goldenberg et al., US 7,641,901 B2, issued Jan. 5, 2010
("Goldenberg '901 ").
3 Frederick Wolfe, The epidemiology of drug treatment failure in
rheumatoid arthritis, 9 Bailliere's Clinical Rheumatology 619-632
(1995).
2
Appeal2015-000434
Application 13/349,755
C. The Examiner rejected claims 1, 13-15, 17, and 23-25 on the ground
of nonstatutory obviousness-type double patenting as being unpatentable
over claims 1-20 of Goldenberg '403 4 in view of Wolfe (Final Act. 3).
D. The Examiner rejected claims 1, 13-15, 17, 23-25, 30, and 36-38 on
the ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1--47 of Goldenberg '901 in view of Goodkin5
(Final Act. 3--4).
E. The Examiner rejected claims 1, 13-15, 17, 23-25, 30, and 36-38 on
the ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1-20 of Goldenberg '403 in view of Goodkin
(Final Act. 4 ).
F. The Examiner rejected claims 1, 13-15, 17, 23-25, 30, and 36-38
under 35 U.S.C. § 103(a) as obvious over Curd, 6 Leung,7 and Goodkin
(Final Act. 7-8).
G. The Examiner rejected claims 1, 13-15, 17, 23-25, 30, and 36-38
under 35 U.S.C. § 103(a) as obvious over Curd, Leung, and Wolfe (Final
Act. 8-9).
4 Goldenberg et al., US 7,074,403 Bl, issued July 11, 2006
("Goldenberg '403").
5 Goodkin et al., Low-Dose (7.5 mg) Oral Methotrexate Reduces
the Rate of Progression in Chronic Progressive Multiple Sclerosis,
37 Ann. Neurol. 30--40 (1995) ("Goodkin").
6 Curd et al., US 7,820,161 B 1, issued Oct. 26, 2010 ("Curd").
7 Leung et al., Construction and Characterization of a Humanized,
Internalizing, B-Cell (CD22)-Specific Leukemia/Lymphoma
Antibody, LL2, 32 Mol. Immunology 1413-1427 (1995).
3
Appeal2015-000434
Application 13/349,755
A. 35 US.C. § 112,firstparagraph
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the phrase "having failed
methotrexate therapy" lacks descriptive support in the Specification?
Findings of Fact
1. The Specification teaches that "it is an object of the present
invention to provide a method for treating autoimmune diseases using
antibody to a B-cell antigen. It is another object of the invention is to use
comparatively low doses of a naked antibody to a B-cell antigen, preferably
to CD22 antigen" (Spec. 2, 11. 20-25).
2. The Specification teaches
treatment of Class III autoimmune diseases including immune-
mediated thrombocytopenias, such as acute idiopathic
thrombocytopenic purpura and chronic idiopathic
thrombocytopenic purpura, dermatomyositis, Sydenham's
chorea, myasthenia gravis, systemic lupus eI)rthematosus, lupus
nephritis, rheumatic fever, polyglandular syndromes, bullous
pemphigoid, diabetes mellitus, Henoch-Schonlein purpura,
post-streptococcal nephritis, erythema nodosum, Takayasu's
arteritis, Addison's disease, rheumatoid arthritis[,] multiple
sclerosis, sarcoidosis, ulcerative colitis, erythema multiforme,
IgA nephropathy, polyarteritis nodosa, ankylosing spondylitis,
Goodpasture's syndrome, thromboangitis ubiterans, Sjogren's
syndrome, primary biliary cirrhosis, Hashimoto' s thyroiditis,
thyrotoxicosis, scleroderma, chronic active hepatitis,
polymyositis/ dermatomyositis, polychondritis, pamphigus
vulgaris, Wegener' s granulomatosis, membranous nephropathy,
amyotrophic lateral sclerosis, tabes dorsalis, giant cell
arteritis/polymyalgia, pernicious anemia, rapidly progressive
glomerulonephritis and fibrosing alveolitis.
(Spec.15:17to 16:1).
4
Appeal2015-000434
Application 13/349,755
3. The Specification teaches, in Example 3, that a "60-year-old
male, with severe progressive rheumatoid arthritis of the finger joints, wrists,
and elbows, has failed therapy with methotrexate, and obtains only minor
relief when placed on Enbrel therapy. The patient is then treated with hLL2,
600 mg intravenously each week, for a period of eight weeks" (Spec. 21, 11.
13-16).
Principles of Law
"[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure ... or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement." Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010)(citations omitted).
Analysis
The Examiner finds that "[ t ]here is no support in the specification as
originally filed for the recitation of 'and having failed methotrexate therapy'
in claim 1" and the "disclosure [in Example 3] is not of the scope of the
claimed invention which encompasses use of hLL2 antibody to treat any
autoimmune disease including MS using any amount of antibody" (Final
Act. 6).
Appellants contend that "the teaching of successful therapy with the
presently claimed anti-CD22 antibody for a class of patients that had failed
methotrexate therapy for RA would be understood by the knowledgeable
reader to apply to classes of patients with other autoimmune diseases" (App.
Br. 10).
5
Appeal2015-000434
Application 13/349,755
We find that the Appellants have the better position. 8 The
Specification generally teaches treatment of a wide variety of autoimmune
diseases (FF 2) with antibodies to the CD22 antigen (FF 1 ). Example 3
specifically discloses treatment of an autoimmune disorder, rheumatoid
arthritis, in a human subject who failed methotrexate therapy, with an anti-
CD22 antibody (FF 3), teaching all of the limitations of the claim.
While not every species of autoimmune diseases was exemplified,
written description does not require every species but rather "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."
Ariad, 598 F.3d at 1350. Here, Appellants have provide a list of
representative species of autoimmune disorders (FF 2) that permits the
ordinary artisan to visualize essentially the entire genus and describes the
genus, the essence of the written description requirement.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the phrase "having failed methotrexate therapy" lacks descriptive
support in the Specification.
8 We note that this result is not inconsistent with our Decision in
2014-003726 (US 13/178,307) where we affirmed the written
description rejection because that claim was to treatment with an
anti-CD74 antibody and there was not disclosure or an example
showing treatment of patients having failed methotrexate therapy
using that antibody, unlike the current claims to anti-CD22
antibody treatment expressly demonstrated in Example 3 (FF 3).
6
Appeal2015-000434
Application 13/349,755
B.-E. Obviousness-Type Double Patenting
Because substantially the same issues are dispositive for each of the
double patenting rejections, we will consider them together.
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that the claims of either
Goldenberg '901 or Goldenberg '403 in combination with either Wolfe or
Goodkin render claim 1 obvious?
Findings of Fact
4. Claim 1 of Goldenberg '901 reads: "A method for treating an
autoimmune disorder comprising administering to a human subject having
an autoimmune disorder an effective amount of a therapeutic composition
comprising a pharmaceutically acceptable carrier and at least one non-
blocking anti-CD22 antibody, wherein said antibody is a naked antibody"
(Goldenberg '901 15:1-7).
5. Claim 1 of Goldenberg '403 reads: "A method for treating an
autoimmune disorder, comprising administering to a subject having an
autoimmune disorder, an effective amount of a therapeutic composition
comprising a pharmaceutically acceptable carrier and at least one non-
blocking anti-CD22 antibody." (Goldenberg '403 15:40-44).
6. Wolfe teaches that the "length of time that patients remain on
anti-rheumatic therapy is an important measure of the effectiveness of that
therapy ... we will use the newer terminology, SMARD, or symptom-
modifying anti-rheumatic drug" (Wolfe, abstract).
7. Wolfe asks "[ w ]hy do patients . . . change from one therapy to
another?" (Wolfe 624) (emphasis omitted).
7
Appeal2015-000434
Application 13/349,755
8. Table 4 of Wolfe is reproduced below:
Table 4. Reasons for drug discontinuation.
I. Lack of efficacy
2. Adverse reactions
3. Costs
4. PsydroJogical factors
5. Concomitant fibromynlgia
6. Non-compliance
7. Non-medical factors
8. Misunderst:mding
9. Pn::scription expired
10. Improvement or remission
Wolfe teaches that a "number of factors are responsible for drug
discontinuation besides lack of efficacy and adverse reactions (Table 4)"
(Wolfe 624---625).
9. Table 5 of Wolfe is reproduced in part below:
Table 5. Reasons for dis~ontinuation of SMARD therapy.
Drug Toxicity Efficacy Remission Combined Other
McKendry and Dale (1993)
Buchbinder et at ( 1993)
Pincus et al (1992a)
MTX 53% 22% 25%
MTX 66.3% 32.7%
MTX 52.9% 14.7% 29.4%
"Table 5 reports on specific drugs and reasons for their discontinuation"
(Wolfe 624---625). "MTX" is methotrexate (Wolfe 624 and Fig. 1).
10. Goodkin teaches that multiple sclerosis "patients stopped taking
the drug for the following reasons: 3 MTX and 1 PLC [placebo] patient felt
the drug was not working" (Goodkin 33, col. 1 ).
Principles of Law
Obviousness-type double patenting is a judicially-created doctrine
designed to "prevent claims in separate applications or patents that do not
recite the 'same' invention, but nonetheless claim inventions so alike that
granting both exclusive rights would effectively extend the life of patent
8
Appeal2015-000434
Application 13/349,755
protection." Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1373 (Fed.
Cir. 2005).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3--4; FF 4--10) and agree that
the claims are rendered obvious by either Goldenberg '901 or Goldenberg
'403 in combination with either Wolfe or Goodkin.
In particular, Wolfe teaches treatment of rheumatoid arthritis with
anti-rheumatic drugs including methotrexate (FF 6). Wolfe asks "[ w ]hy do
patients ... change from one therapy to another?" (FF 7) and answers that
drugs are sometimes discontinued for lack of efficacy (FF 8) and that
sometimes the reason methotrexate therapy is discontinued is due to lack of
efficacy (FF 9). Goodkin similarly teaches that multiple sclerosis patients
stopped taking methotrexate for treatment failure (FF 10).
Claim 1 of either Goldenberg '901 or Goldenberg '403 teaches
treatment of autoimmune diseases with anti-CD22 antibodies (FF 4--5).
We agree with the Examiner that the ordinary artisan would have
found it obvious that after methotrexate was discontinued for lack of
efficacy in treating rheumatoid arthritis, as taught by Wolfe (FF 9), or
multiple sclerosis, as taught by Goodkin (FF 10), the ordinary artisan would
change from that therapy to the anti-CD22 antibody treatment of Goldenberg
'901 or Goldenberg '403 in order to obtain treatment efficacy (FF 4--5).
We address Appellants' arguments below.
Appellants contend that:
As to the examiner's reliance on Wolfe, it is noted that with any
therapy there always will be some patients that fail to respond.
9
Appeal2015-000434
Application 13/349,755
In fact, in Table 4 of Wolfe, which is the basis cited by the
examiner in the rejection as supporting the case for
obviousness, lack of efficacy is listed as the number one reason
for discontinuing therapy with any drug. Thus, this cannot be a
proper standard to be applied for determining obviousness in
cases such as the present case. Were such an approach to be
followed, patentability for a method of therapy of claim [sic]
could not be based as here on defining a patient population that
differed from the patient population in the cited art. Yet this is
an accepted practice.
(App. Br. 3--4; cf App. Br. 4---6).
We are not persuaded. Appellants do not identify any evidence or
legal doctrine that supports their position that claims limiting a second
therapy to a patient population comprising patients who have failed a
particular first therapy should be nonobvious over art teaching both the first
and second therapies (FF 4--10), teaching that the first therapy is subject to
failure (FF 6-10), and teaching that the ordinary artisan may change
therapies (FF 7) for lack of efficacy (FF 8). See In re Pearson, 494 F .2d
13 99, 1405 ( CCP A 197 4) ("Attorney's argument in a brief cannot take the
place of evidence.")
F. and G. 35 US.C. § 103(a) over Curd, Leung, and either Goodkin or
Wolfe
Because substantially the same issues are dispositive for each of these
obviousness rejections, we will consider them together.
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that Curd and Leung in
combination with either Wolfe or Goodkin render claim 1 obvious?
10
Appeal2015-000434
Application 13/349,755
Findings of Fact
11. Curd teaches a "method of treating an autoimmune disease in a
mammal comprising administering to the mammal a therapeutically
effective amount of an antagonist which binds to a B cell surface marker"
(Curd, col. 2, 11. 60-64).
12. Curd teaches that "[ e ]xamples of autoimmune diseases or
disorders include, but are not limited to ... rheumatoid arthritis" (Curd, col.
3, 11. 50-62).
13. Curd teaches that "[ e ]xemplary B cell surface markers include
the ... CD22 ... leukocyte surface markers" (Curd, col. 3, 11. 13-17).
14. Curd teaches that the "preferred antagonist comprises an
antibody" (Curd, col. 4, 11. 31-32).
15. Curd teaches that the "monoclonal antibodies herein
specifically include 'chimeric' antibodies .... 'Humanized' forms of non-
human (e.g., murine) antibodies are chimeric antibodies that contain
minimal sequence derived from non-human immunoglobulin" (Curd, col. 7,
11. 41---60).
16. Curd teaches that "the patient is optionally further treated with
any one or more agents employed for treating RA such as ... methotrexate"
(Curd, col. 27, 11. 39-49).
17. Leung teaches "the successful humanization of an internalizing
murine MAb, LL2, which recognizes CD22 ... a B-cell-restricted
phosphoglycoprotein that is expressed in the cytoplasm and on the surface of
pre-Band mature B-cells, respectively" (Leung 1414, col. 1).
11
Appeal2015-000434
Application 13/349,755
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 7-9; FF 6-17) and agree that
the claims are rendered obvious by Curd, Leung, and either Wolfe or
Goodkin. We address Appellants' arguments below.
Appellants contend that
Curd includes one reference to a CD22 antibody in the
background and another reference to CD22 in a long list of B
cell antigens given as a definition near the beginning of the
specification. The remainder of Curd directs the reader to
"treatment of autoimmune diseases with antagonists which bind
to B cell surface markers, such as CD19 or CD20," and then
focuses entirely on Rituxan.
(App. Br. 12).
We find this argument unpersuasive because obviousness does not
require any particular amount of disclosure in the prior art, so long the as the
claims are rendered obvious by the prior art. Here, Curd suggests treating
autoimmune disorders with antibodies to B-cell markers (FF 11 ), including
CD22 i (FF 13). Curd also suggests humanized antibodies (FF 15) and
Leung evidences a humanized anti-CD22 antibody for therapeutic purposes
(FF 17). Thus, Curd and Leung suggest the claimed elements other than the
12
Appeal2015-000434
Application 13/349,755
requirement for treating patients who failed methotrexate therapy for which
the Examiner relies upon either Goodkind or Wolfe (see Final Act. 7-9).
Appellants contend that
not only does Curd et al. fail to teach a population that has
failed methotrexate therapy, but it also teaches co-
administration of methotrexate to the target population. This is
an unambiguous indication that administration of antagonists
which bind to B cell surface markers to treat autoimmune
diseases in patients that have failed methotrexate therapy was
not envisaged by Curd et al., and certainly would not have
informed the skilled artisan of this possibility.
(App. Br. 12-13).
We do not find this argument persuasive because the rejection does
not rely upon Curd alone, but rather on the combination of Curd and Leung
with either Wolfe or Goodkin. "Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references." In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986). In determining obviousness, furthermore, a
reference "must be read, not in isolation, but for what it fairly teaches in
combination with the prior art as a whole." Id.
Appellants' arguments fail to address the combined teachings of Curd
and Leung with either Wolfe or Goodkin. As already noted, Wolfe teaches
treatment of rheumatoid arthritis with anti-rheumatic drugs including
methotrexate (FF 6). Wolfe asks"[ w ]hy do patients ... change from one
therapy to another?" (FF 7) and answers that drugs are discontinued for lack
of efficacy (FF 8) and that sometimes the reason methotrexate therapy is
discontinued is due to lack of efficacy (FF 9). Goodkin also teaches
13
Appeal2015-000434
Application 13/349,755
methotrexate therapy may be discontinued due to lack of efficacy (FF 10).
Curd reasonably suggests treatment of autoimmune disorders including
rheumatoid arthritis (FF 11-12) with chimeric and/or humanized antibody
antagonists (FF 14--15) to B cell surface markers including CD22 (FF 13).
We agree with the Examiner that the ordinary artisan would have found it
obvious that after methotrexate was discontinued for lack of efficacy in
treating rheumatoid arthritis, as taught by Wolfe (FF 9) or Goodkin (FF 10),
the ordinary artisan would change from that therapy to Curd's anti-CD22
antibody treatment for rheumatoid arthritis in order to obtain efficacy from
Curd and Leung's obvious treatment of rheumatoid arthritis (FF 11-17).
We understand that Curd teaches that "the patient is optionally further
treated with any one or more agents employed for treating RA such as ...
methotrexate" (FF 16 (emphasis added)). However, we do not agree with
Appellants that the teaching of this option suggests that Curd's CD22
antibody would not have been administered to treat a subject that has failed
methotrexate.
Appellants contend that "this cannot be a proper standard to be
applied for determining obviousness in cases such as the present case. Were
such an approach to be followed, patentability for a method of therapy of
claim [sic] could not be based as here on defining a patient population that
differed from the patient population in the cited art" (App. Br. 5-6).
We are not persuaded. Appellants do not identify any evidence or
legal doctrine that supports their position that claims limiting a second
therapy to a patient population comprising patients who have failed a
particular first therapy should be nonobvious over art teaching both the first
14
Appeal2015-000434
Application 13/349,755
and second therapies (FF 11-15), teaching that the first therapy is subject to
failure (FF 8-10), and teaching that the ordinary artisan may change
therapies (FF 7) for lack of efficacy (FF 8). Pearson, 494 F.2d at 1405.
Conclusions of Law
The evidence of record supports the Examiner's conclusion that Curd
and Leung in combination with either Wolfe or Goodkin render claim 1
obvious.
SUMMARY
In summary, we reverse the rejection of claims 1, 13-15, 17, 23-25,
30, and 36-38 under 35 U.S.C. § 112(a) or§ 112, first paragraph, as failing
to comply with the written description requirement.
We affirm the rejection of claim 1 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1--47
of Goldenberg '901 in view of Wolfe. Claims 13-15, 17, and 23-25 fall
with claim 1.
We affirm the rejection of claim 1 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1-20
of Goldenberg '403 in viewofWolfe. Claims 13-15, 17, and23-25 fall
with claim 1.
We affirm the rejection of claim 1 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1--47
of Goldenberg '901 in view of Goodkin. Claims 13-15, 17, 23-25, 30, and
3 6-3 8 fall with claim 1.
15
Appeal2015-000434
Application 13/349,755
We affirm the rejection of claim 1 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1-20
of Goldenberg '403 in view of Goodkin. Claims 13-15, 17, 23-25, 30, and
36-38 fall with claim 1.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Curd, Leung, and Goodkin. Claims 13-15, 17, 23-25, 30, and
3 6-3 8 fall with claim 1.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Curd, Leung, and Wolfe. Claims 13-15, 17, 23-25, 30, and
3 6-3 8 fall with claim 1.
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
16