Ex Parte Goldenberg et al

Patent Trial and Appeal Board

Sep 27, 2017

13682037 (P.T.A.B. Sep. 27, 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.
13/682,037 11/20/2012 David M. GOLDENBERG IMMU-0005US7 2303
37013 7590 09/29/2017
Rossi, Kimms & McDowell LLP
20609 Gordon Park Square
Suite 150
Ashburn, VA 20147
EXAMINER
SCHWADRON, RONALD B
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
09/29/2017 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 and HANS J. HANSEN
Appeal 2016-006998
Application 13/682,037
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
method for treating an autoimmune disorder. The Examiner rejected1 2 3 the
claims as failing to comply with the written description requirement, as
being in improper dependent form, as anticipated, as obvious, and on the
grounds of obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Immunomedics, Inc. {see
App. Br. 2).
2 Appellants identify related proceedings US 10/350,096 (2015-001997), US
13/178,307 (2014-003726), US 13/349,755 (2015-000434), and US
13/214,767 (2014-006809) (see App. Br. 2).
3 The Examiner withdrew a rejection under 35 U.S.C. § 112, second
paragraph based on amendments entered June 22, 2015 (see Ans. 10—11).
Appeal 2016-006998
Application 13/682,037
Statement of the Case
Background
“Autoimmune diseases are a class of diseases associated with a B-cell
disorder. Examples include . . . myasthenia gravis, lupus nephritis, lupus
erythematosus, and rheumatoid arthritis” (Spec. 2:6—10). “The most
common treatments are corticosteroids and cytotoxic drugs, which can be
very toxic. These drugs also suppress the entire immune system, can result
in serious infection, and have adverse [e] fleets on the liver and kidneys”
(Spec. 2:10—12). “A need remains for more effective methods of treating
autoimmune diseases” (Spec. 2:14—15).
“[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. 1:15-17).
The Claims
Claims 2, 3, 5, 8—13, 20-23, and 28—31 are on appeal. Claims 8, 28,
and 31 are representative and read as follows:
8. A method for treating an autoimmune disorder,
comprising administering to a subject having an autoimmune
disorder a pharmaceutical composition comprising an
immunoconjugate comprising a chimeric, humanized, or human
anti-CD74 antibody, antigen-binding antibody fragment or
antibody fusion protein that binds to human CD74 and that is
conjugated to a drug, and a pharmaceutically acceptable carrier.
28. The method according to claim 8, wherein the subject has
failed methotrexate therapy.
31. The method according to claim 30, wherein the
autoimmune disease is systemic lupus erythematosus.
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The Issues
A. The Examiner rejected claims 28, 30, and 31 under 35 U.S.C. § 112,
first paragraph as failing to comply with the written description requirement
(Final Act. 5—6)
B. The Examiner rejected claims 2, 3, and 5 under 35 U.S.C. § 112,
fourth paragraph as failing to further limit the subject matter of a previous
claim (Final Act. 7)
C. The Examiner rejected claims 2, 3, 5, 8—13, 20-23, and 29 under 35
U.S.C. § 102(e) as anticipated by Curd4 (Final Act. 8—9).
D. The Examiner rejected claims 2, 3, 5, 8—13, 20-23, and 28—30 under
35 U.S.C. § 103(a) as obvious over Curd and Wolfe5 (Final Act. 10—11).
E. The Examiner rejected claims 2, 3, 5, 8—13, 20-23, and 28—30 under
35 U.S.C. § 103(a) as obvious over Curd and Rittershaus6 (Final Act. 12—
13).
F. The Examiner rejected claims 2, 3, 5, 8—13, 20-23, and 28—31 under
35 U.S.C. § 103(a) as obvious over Curd, Rittershaus, Skurkovich,7 and
Stetler8 (Final Act. 13—14).
G. The Examiner rejected claims 2, 3, 5, 8—13, 20-23 and 29 for
obviousness-type double patenting over claims 6—18, 20, 27—29, 31, and 32
ofU.S. Patent No. 7,772,373 (Final Act. 3).
4 Curd et al., US 7,820,161 Bl, issued Oct. 26, 2010.
5 Frederick Wolfe, The epidemiology of drug treatment failure in rheumatoid
arthritis, 9 Balliere’s Clinical Rheumatology 619-632 (1995).
6 Rittershaus et al., US 5,766,947, issued June 16, 1998.
7 Skurkovich et al., US 2005/0175604 Al, published Aug. 11, 2005.
8 Stetler, US 5,340,720, issued Aug. 23, 1994.
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H. The Examiner rejected claims 2, 3, 5, 8—13, 20-23, and 28—31 for
obviousness-type double patenting over claim 6—18, 20, 27—29, 31, and 32
ofU.S. Patent No. 7,772,373 and Wolfe, Rittershaus, Skurkovich, and
Stetler (Final Act. 3—4).
I. The Examiner rejected claims 2, 3, 5, 8—13, 20-23, and 29 for
obviousness-type double patenting over claim 1—34 ofU.S. Patent No.
7,683,044 (Final Act. 4).
J. The Examiner rejected claims 2, 3, 5, 8—13, 20-23, and 28—31 for
obviousness-type double patenting over claims 1—34 ofU.S. Patent No.
7,683,044 and Wolfe, Rittershaus, Skurkovich, and Stetler (Final Act. 4—5).
A. 35 U.S.C. § 112, first paragraph
The Examiner finds that “[tjhere is no support in the specification as
originally filed for the recitation of ‘and having failed methotrexate therapy’
in claims 28, 30” consistent with “the scope of the claimed invention which
encompasses use of conjugated anti CD74 antibody to treat any autoimmune
disease” (Final Act. 5—6).
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, or a combination of naked
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Application 13/682,037
antibodies to a CD22 antigen and another B-cell antigen,
preferably CD20 and/or CD74.
(Spec. 2:20-25).
2. The Specification teaches that:
In an alternative embodiment, the antibodies to the
CD22, CD20, CD 19, and CD74 or HLA-DR antigen are
conjugated to a drug. . . . Drugs which are known to act on B-
cells, plasma cells and/or T-cells are particularly useful in
accordance with the present invention, whether conjugated to a
B-cell antibody, or administered as a separate component in
combination with a naked or conjugated B-cell antibody. These
include methotrexate.
(Spec. 16:19 to 17:2).
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. 21:13—
16).
4. The Specification teaches that “a suitable murine anti-CD22
monoclonal antibody is the LL2 (formerly EPB-2) monoclonal antibody
(Spec. 8:21—22). “hLL2” is humanized LL2 (Spec. 19:13—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).
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Analysis
Appellants contend:
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 treatment of patients with
other antibodies disclosed in the present specification, in which
methotrexate therapy had failed, as methotrexate is used as a
first line of therapy in diseases other than RA.
(App. Br. 6).
The Examiner responds “the only disclosure in the specification even
vaguely related to said limitation is Example 3. However, said example
does not disclose use of humanized anti CD74 antibodies. Said disclosure is
limited to use of antiCD22 antibody” (Ans. 14; emphasis omitted).
We find that the Examiner has the better position. We agree with the
Examiner that the Specification does not demonstrate possession of a
method for treating an autoimmune disorder of a patient who has failed
methotrexate therapy with an anti-CD74 antibody or fusion protein. The
focus of the Specification is treatment with anti-CD22 antibodies, which
may be used in combination with other antibodies such as anti-CD74 (FF 1).
The example discloses treatment with an anti-CD22 antibody after
methotrexate treatment failure (FF 3—4), but does not disclose treatment with
an anti-CD74 antibody after methotrexate treatment failure.
While the Specification may render the claimed method obvious, the
Examiner correctly notes that obviousness is not the standard for written
description (see Ans. 15). As Lockwood explains “[entitlement to a filing
date does not extend to subject matter which is not disclosed, but would be
obvious over what is expressly disclosed. It extends only to that which is
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disclosed.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571—
1572 (Fed. Cir. 1997). “A description which renders obvious the invention
for which an earlier filing date is sought is not sufficient.” Id.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
phrase “having failed methotrexate therapy” lacks descriptive support in the
Specification.
B. 35 U.S.C. § 112, fourth paragraph
The Examiner finds: “Claims 2, 3, 5 are improperly dependent
because they do not limit a previous claim” (Ans. 16).
Appellants contend:
It is standard USPTO practice to renumber claims upon
allowance, at which point claim 8 in the present case would
become claim 1, and claims 2, 3, and 5 would then refer to
claim 1. In over thirty years of practice, the undersigned has
never encountered a rejection under the fourth paragraph of
Section 112 on this basis.
(App. Br. 7).
We find Appellants have the better position. The MPEP notes that
during prosecution “the order of claims may change and be in conflict with
the requirement that dependent claims refer to a preceding claim.
Accordingly, the numbering of dependent claims and the numbers of
preceding claims referred to in dependent claims should be carefully
checked when claims are renumbered upon allowance” (MPEP
§ 608.0l(n)(IV)). Thus, the MPEP explains that claims may temporarily
depend from later claims during the course of prosecution because claim
numbering may change, consistent with 37 C.F.R. § 1.126. The Examiner
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does not identify any support in the MPEP or caselaw for the proposition
that claim numbering during the course of prosecution, even claim
numbering inconsistent with 37 C.F.R. § 1.126, is subject to rejection under
35 U.S.C. § 112(d) or 35 U.S.C. § 112, fourth paragraph.
We reverse this rejection.
C. 35 U.S.C. § 102(e) over Curd
The Examiner finds Curd teaches “treatment of autoimmune disease
including SLE with conjugated humanized anti-CD74 antibody
pharmaceutical composition and prednisone” (Final Act. 8).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Curd anticipates claim 8?
Findings of Fact
5. 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 2:60-64).
6. Curd teaches “[ejxamples of autoimmune diseases or disorders
include, but are not limited to . . . rheumatoid arthritis, systemic lupus
erythematosus (SLE)” (Curd 3:50-63).
7. Curd teaches “[ejxemplary B cell surface markers include the
. . . CD74 . . . leukocyte surface markers” (Curd 3:13—17).
8. Curd teaches “[antagonists included within the scope of the
present invention include antibodies . . . optionally conjugated with or fused
to a cytotoxic agent” (Curd 4:27—31). Curd teaches cytotoxic agents include
chemotherapeutic agents (Curd 9:66 to 10:4) such as doxorubicin (see Curd
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10:26) and teaches the use of “[fjurther adjunct therapies (such as . . .
prednisone . . .) may be combined with the [antibody] therapy” (Curd
28:16-17).
9. 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 7:41—
60).
10. Curd teaches: “Therapeutic formulations of the antagonists used
in accordance with the present invention are prepared for storage by mixing
an antagonist having the desired degree of purity with optional
pharmaceutically acceptable carriers” (Curd 24:7—10).
Principles of Law
Anticipation under 35 U.S.C. § 102 requires that “each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference.” In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999).
Analysis
Appellants contend “Curd et al. includes a single reference to CD74,
in a long list of B cell antigens given in a long laundry list of definitions near
the beginning of the specification. . . . The examiner has taken this single
reference to CD74 and combines it with general descriptions with respect to
conjugates to allege obviousness [sic]” (App. Br. 13).
The Examiner contends that “apparently appellant believes that so
called laundry lists are appropriate in their own applications (aka see original
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claim 9 or claim 2 or page 11 or page 15 or page 17) but are somehow
problematic when listed in the prior art” (Ans. 20; emphasis omitted).
We find Appellants have the better position. “[Cjombining various
disclosures not directly related to each other by the teachings of the cited
reference . . . may be entirely proper in the making of a 103, obviousness
rejection . . . but it has no place in the making of a 102, anticipation
rejection.” In reArkley, 455 F.2d 586, 587 (CCPA 1972). Here, while Curd
provides significant teachings regarding the claimed invention, a number of
separate selections from disparate portions of Curd are required to identify
teachings that address claim 8 (FF 5—10). We agree with Appellants that
this requires more picking and choosing than is compatible with an
anticipation rejection.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Curd anticipates claim 8.
D. 35 U.S.C. § 103(a) over Curd and Wolfe
The Examiner finds that Curd teaches “treatment of autoimmune
disease including SLE with conjugated humanized antiCD74 antibody” but
Curd does “not teach that the patient has previously failed methotrexate
therapy” (Final Act. 10—11). The Examiner finds that Wolfe teaches “that
some patients with RA fail methotrexate therapy” (Final Act. 11).
The Examiner finds the Curd and Wolfe render the claims obvious
because “it was known in the art that some RA patients fail methotrexate
therapy” so it would have been “routine medical practice that such patients
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Application 13/682,037
would be treated with a different art known therapy to treat the disease”
(Ans. 23).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Curd and Wolfe render claims
8, 28, and 30 obvious?
Findings of Fact
11. 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).
12. Wolfe asks “[w]hy do patients . . . change from one therapy to
another?” (Wolfe 624).
13. Table 4 of Wolfe is reproduced below:
Table 4, Reasons for drug discontinuation.
L Lack of efficacy
2. Adverse reactions
3. Costs
4. Psychological factors
5. Concomitant fibromyalgia
6. Non-compliance
7. Non-medical factors
$. Misunderstanding
9. Prescription expired
IQ. 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).
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14. Table 5 of Wolfe is reproduced in part below:
Table 5. Reasons for discontinuation of SMARD therapy.
Drag Toxicity Efficacy Remission Combined Other
MeKendry and Dale (1993) MTX 53% 22% 25%
Buchbrader et at (1993) MTX 66,3% 32.7%
Pincus et ai (1992a) MTX 52.9% 14.7% 29.4%
“Table 5 reports on specific drugs and reasons for their discontinuation”
(Wolfe 624—625). “MTX” stands for methotrexate. (See Wolfe 622, last
paragraph.)
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.”
KSRInt’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.” Mat417.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 10—11; FF 5—14) and agree that
the claims are rendered obvious by Curd and Wolfe. We address
Appellants’ arguments below.
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. 15—16).
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We do not find this argument persuasive because the rejection does
not rely upon Curd alone, but rather on the combination of Curd and Wolfe.
“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’ argument fails to address the combined teachings of Curd
and Wolfe. Wolfe teaches treatment of rheumatoid arthritis with anti­
rheumatic drugs (FF 11) including methotrexate (FF 14). Wolfe asks “[w]hy
do patients . . . change from one therapy to another?” (FF 12) and answers
that drugs are often discontinued for lack of efficacy (FF 13) and that
sometimes the reason methotrexate therapy is discontinued is due to lack of
efficacy (FF 14). Curd reasonably suggests treatment of autoimmune
disorders including rheumatoid arthritis and SLE (FF 5—6) with chimeric
and/or humanized antibody antagonists (FF 8—9) to B cell surface markers
including CD74 (FF 7) as well as conjugated drugs (FF 8) and
pharmaceutically acceptable carriers (FF 10). We agree with the Examiner
that the ordinary artisan would have found it obvious that, after methotrexate
therapy was discontinued for lack of efficacy in treating rheumatoid arthritis,
as taught by Wolfe (FF 14), changing to Curd’s anti-CD74 antibody
treatment for rheumatoid arthritis was a reasonable step in order to obtain
efficacy from Curd’s obvious treatment of rheumatoid arthritis and SLE (FF
5-10).
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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 could not be based as here on defining a patient population that
differed from the patient population in the cited art” (App. Br. 16).
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 prior art teaching both the
first and second therapies (FF 5—9, 14), teaching that the first therapy is
subject to failure (FF 12—13), and teaching that the ordinary artisan may
change therapies (FF 11) for lack of efficacy (FF 12). See In re Pearson,
494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot
take the place of evidence.”)
We have also reviewed Appellants’ cited evidence regarding
secondary considerations (see Appeal Br. 13—149), insofar as they relate to
the obviousness rejection, including Griffiths,10 Sapra,* 11 Govindan,12
9 Appellants include a discussion of several references with respect
to treating autoimmune diseases in their arguments regarding the
anticipation rejection. To the extent that Appellants intended the
references to be evidence of unexpected results, we have
considered them with respect to the obviousness rejections.
10 Griffiths et al., Cure of SCID Mice Bearing Human B-Lymphoma
Xenografts by an Anti-CD74 Antibody-Anthracycline Drug Conjugate, 9
Clinical Cancer Res. 6567-71 (2003).
11 Sapra et al., Anti-CD74 Antibody-Doxorubicin Conjugate, IMMU-110, in
a Human Multiple Myeloma Xenograft and in Monkeys, 11 Clinical
Cancer Res. 5257-64 (2005).
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Chen,13 Tivol,14 and Tyndall,15 but find the evidence unpersuasive for
several reasons.
We recognize, but find unpersuasive, Appellants’ contention that:
“This ability of anti-CD74 antibodies to treat an autoimmune disease
without compromising T-cell immunity sets it apart from other therapies,
and is not suggested in Curd, which contains only a single mention of CD74
in a long list of B cell antigens” (App. Br. 14).
Appellants have presented no evidence, or even asserted in the brief,
that the results shown in the cited references would not have been expected
by those of ordinary skill in the art. Curd does provide evidence that the
ordinary artisan would have expected these antibodies to treat autoimmune
disease (FF 5). Moreover, Appellants’ claim 8 broadly encompasses any
autoimmune disorder, but the evidence does not show unexpected results for
the full scope of this claim. See In re Harris, 409 F.3d 1339, 1344 (Fed. Cir.
2005) (Unexpected results must also be “commensurate in scope with the
degree of protection sought by the claimed subject matter.”)
12 Govindan et al., Milatuzumab-SN-38 Conjugates for the Treatment of
CD74+ Cancers, 12 Molecular Cancer Ther. 968-78 (2013).
13 Chen et al., Prevention of Acute Graft-versus-Host Disease in a
Xenogeneic SCID Mouse Model by the Humanized Anti-CD74 Antagonistic
Antibody Milatuzumab, 19 Biol. Blood Marrow Transplant. 28—39
(2013).
14 Tivol et al., Emergent autoimmunity in graft-versus-host disease,
105 Blood 4885-91(2005).
15 Tyndall et al., Chronic GVHD as an autoimmune disease, 21
Best Practices Res. Clin. Haematol. 281-9 (2008).
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Conclusion of Law
The evidence of record supports the Examiner’s conclusion Curd and
Wolfe render claims 8, 28, and 30 obvious.
E. 35 U.S.C. § 103(a) over Curd andRittershaus
The Examiner finds Curd teaches “treatment of autoimmune disease
including SLE with conjugated humanized antiCD74 antibody
pharmaceutical composition” but does not “teach that the patient has
previously failed methotrexate therapy” (Final Act. 12). The Examiner finds
Rittershaus teaches “that RA patients who fail treatment with methotrexate
are than treated with other therapies” (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Curd and Rittershaus render
claims 8, 28, and 30 obvious?
Findings of Fact
15. Rittershaus teaches:
The approach to drug treatment in rheumatoid arthritis has been
described as a pyramid . . . First line agents include aspirin and
NSAIDS (non-steroidal anti-inflammatory dmgs). When these
agents fail, gold salts, penicillamine, methotrexate, or
antimalarials, known as conventional second line dmgs, are
considered. Finally, steroids or cytotoxics are tried in patients
with serious active disease that is refractory to first and second
line treatment.
(Rittershaus 4:5—13).
16. Rittershaus teaches: “Cytotoxic dmgs which can be conjugated
to antibodies and subsequently used for in vivo therapy include, but are not
limited to, daunombicin, doxorubicin” (Rittershaus 22:36—39).
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Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 12—13; FF 5—10, 15, 16) and
agree that the claims are rendered obvious by Curd and Rittershaus. We
address Appellants’ arguments below.
We recognize, but remain unpersuaded by, Appellants’ repeated
contention 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” (App. Br. 17).
Similar to the rejection above, Appellants’ argument fails to address
the combined teachings of Curd and Rittershaus. Rittershaus teaches an
escalating series of treatments for rheumatoid arthritis with drugs including
methotrexate (FF 15). Curd reasonably suggests treatment of autoimmune
disorders including rheumatoid arthritis and SEE (FF 5—6) with chimeric
and/or humanized antibody antagonists (FF 8—9) to B cell surface markers
including CD74 (FF 7) as well as conjugated drugs (FF 8) and
pharmaceutically acceptable carriers (FF 10). 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 was
taught may occur by Rittershaus (FF 15), the ordinary artisan would change
from that therapy to Curd’s anti-CD74 antibody treatment for rheumatoid
arthritis in order to obtain efficacy from Curd’s obvious treatment of
rheumatoid arthritis and SEE (FF 5—10).
We also recognize, but remain unpersuaded by, Appellants’ repeated
contention that lack of drug efficacy
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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 could not be based as here on defining a patient
population that differed from the patient population in the cited
art.
(App. Br. 17). As noted above, 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 prior art teaching both the
first and second therapies (FF 5—9, 15, 16), teaching that the first therapy is
subject to failure (FF 15), and teaching that the ordinary artisan may change
therapies for lack of efficacy (FF 15). Pearson, 494 F.2d at 1405.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Curd
and Rittershaus render claims 8, 28, and 30 obvious.
F. 35 U.S.C. § 103(a) over Curd, Rittershaus, Skurkovich, andStetler
The Examiner finds Curd teaches “treatment of autoimmune disease
including SLE with conjugated humanized antiCD74 antibody
pharmaceutical composition” but does not teach “the patient has previously
failed methotrexate therapy” (Final Act. 13). The Examiner finds
Rittershaus teaches “that RA patients who fail treatment with methotrexate
are than [sic] treated with other therapies” (id. ). The Examiner finds
Skurkovich teaches “that SLE patients who fail conventional therapy are
treated with other therapies” (id. ). The Examiner finds Stetler teaches
“methotrexate is one of the conventional treatments for SLE” (id. ).
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The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Curd, Rittershaus,
Skurkovich, and Stetler render claim 31 obvious?
Findings of Fact
17. Skurkovich teaches “Human patients with systemic lupus
erythematosus (SLE) were selected . . . The basis for selection was the
patient’s failure to respond to conventional therapy for SLE” (Skurkovich
1125).
18. Skurkovich teaches “one group of patients was treated with
anti-IFNy antibodies, while the other group was treated with anti-IFNy
antibodies and anti-TNF antibodies” (Skurkovich 1125).
19. Stetler teaches: “Therapeutic agents such as prednisone,. . .
methotrexate and cyclophosphamide are used to treat SLE” (Stetler 1:43—
45).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 13—14; FF 5—10, 15—19) and
agree that claim 31 is rendered obvious by Curd, Rittershaus, Skurkovich,
and Stetler. We address Appellants’ arguments below.
We recognize, but remain unpersuaded by, Appellants’ arguments 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” and that lack of efficacy “cannot be a proper
standard to be applied for determining obviousness” (App. Br. 18) for the
reasons already given above.
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Appellants contend the “examiner is using applicant’s claim to pick
pieces from a number of references to cobble together his case of
obviousness. It is quite likely that the patients in Skur[k]ovich were patients
that failed prednisone therapy, a very conventional therapy for SLE, or any
of the other conventional therapies for SLE” (App. Br. 20).
We find this argument unpersuasive because irrespective of which
particular conventional therapy Skurkovich’s actual patients failed, the
ordinary artisan would have recognized Skurkovich directly suggests that a
reason for selecting an antibody therapy for treatment of systemic lupus
erythematosus (FF 18) is “the patient’s failure to respond to conventional
therapy for SLE” (FF 17). Stetler evidences that one such conventional
therapy for SLE is methotrexate (FF 19). Consequently, we agree with the
Examiner that the ordinary artisan, addressing an SLE patient who failed
conventional methotrexate therapy, would have had reason to use Curd’s
antibody treatment for SLE (FF 5—6) using anti-CD74 antibodies conjugated
to cytotoxic agents such as doxorubicin (FF 7—9).
Appellants contend:
various therapies which are conventional actually have quite
different modes of action. The examiner has lumped various
“conventional” therapies together and equated them in order to
allege obviousness of applicant’s invention of using conjugated
anti-CD74 antibody therapy in subjects who have failed
methotrexate therapy. This is a hindsight reconstruction which
uses applicant’s teaching to guide selections from various
references.
(App. Br. 21).
We find this argument unpersuasive. While we are fully aware that
hindsight bias may plague determinations of obviousness, Graham v. John
Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the Supreme
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Court has clearly stated that the “combination of familiar elements according
to known methods is likely to be obvious when it does no more than yield
predictable results.” KSR, 550 U.S. at 416.
As already discussed, Rittershaus explains the “pyramid” of
treatments for autoimmune diseases begins with first line agents. If these
fail, conventional second line agents like methotrexate may be used. If those
agents also fail, additional experimental approaches are used (FF 15) such as
the antibody approach of Curd (FF 5—6). Skurkovich also teaches that
failure to respond to conventional therapy in SLE in particular results in
treatment with antibodies (FF 17—18). Stetler evidences that for SLE,
methotrexate is a conventional agent (FF 19). Therefore, we agree with the
Examiner that treatment of SLE with methotrexate was obvious (FF 19) and
that after failure of such a treatment, it would have been obvious to use
known predictable alternatives such as the treatment of Curd for SLE (FF 5—
6).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Curd,
Rittershaus, Skurkovich, and Stetler render claim 31 obvious.
G-J. Obviousness-type Double Patenting
We summarily affirm the obviousness-type double patenting
rejections because Appellants do not dispute the merits of these rejections
(see App. Br. 3—5). See Manual of Patent Examining Procedure § 1205.02
(“If a ground of rejection stated by the examiner is not addressed in the
appellant’s brief, that ground of rejection will be summarily sustained by the
Board.”)
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SUMMARY
In summary, we affirm the rejection of claims 28, 30, and 31 under 35
U.S.C. § 112, first paragraph as failing to comply with the written
description requirement.
We reverse the rejection of claims 2, 3, and 5 under 35 U.S.C. § 112,
fourth paragraph.
We reverse the rejection of claims 2, 3, 5, 8—13, 20-23, and 29 under
35 U.S.C. § 102(e) as anticipated by Curd.
We affirm the rejection of claims 3,5, 8—13, 20-23, and 28—30 under
35 U.S.C. § 103(a) as obvious over Curd and Wolfe.
We affirm the rejection of claims 2, 3, 5, 8—13, 20-23, and 28—30
under 35 U.S.C. § 103(a) as obvious over Curd and Rittershaus.
We affirm the rejection of claims 2, 3, 5, 8—13, 20-23, and 28—31
under 35 U.S.C. § 103(a) as obvious over Curd, Rittershaus, Skurkovich,
and Stetler.
We affirm the obviousness-type double patenting rejections.
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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