Ex Parte Goldenberg et al

Patent Trial and Appeal Board

Mar 14, 2017

13037784 (P.T.A.B. Mar. 14, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/037,784 03/01/2011 David M. GOLDENBERG IMMU-0022US1A 7553
37013 7590 03/16/2017
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
03/16/2017 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, CHIEN-HSING CHANG, and
HANS J. HANSEN
Appeal 2016-000145
Application 13/037,7841
Technology Center 1600
Before JOHN G. NEW, ELIZABETH A. LaVIER, and DAVID COTTA,
Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner’s rejections of claims 2—5, 7—16, and 28—32. We have jurisdiction
under 35 U.S.C. § 6(b). For the reasons of record and those set forth below,
we AFFIRM.
BACKGROUND
The Specification relates to “structural variants of anti-CD20
antibodies and/or antigen binding fragments thereof, preferably involving
the amino acid sequences of complementarity-determining regions (CDRs),
1 Appellants state the real party in interest is Immunomedics, Inc. Br. 2.
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Application 13/037,784
with improved therapeutic characteristics.” Spec. 12. Claim 2 is
illustrative:
2. A method of treating a disease in a human subject
comprising:
obtaining a substituted chimeric, humanized or human anti-
CD20 antibody or antigen binding fragment thereof which
binds to human CD20 and which is made by substituting the
third complementarity determining region (CDR) sequence of
the heavy chain of a chimeric, humanized or human anti-CD20
antibody or antigen binding fragment thereof at position 101 to
make a substituted antibody or antigen binding fragment
thereof;
improving by the substitution at least one characteristic selected
from the group consisting of a slower off-rate, slower antigen
dissociation rate, higher CDC activity, higher ADCC activity,
higher apoptotic activity, greater ability to induce cell death in
vitro in the absence of cross-linking and greater ability to kill or
inhibit the growth of CD20-positive cells in vivo when
administered to a human subject with CD20-positive cells;
administering the substituted anti-CD20 antibody or fragment
thereof to a subject; and
treating the disease in the human subject, wherein the disease is
selected from the group consisting of B-cell mediated immune
disease, autoimmune disease, B-cell lymphoma and leukemia,
graft-versus-host disease, organ transplant rejection, immune
hemolytic anemia, alio sensitization, and cryoglobulinemia.
Br. 18 (Claims Appendix).
REJECTIONS MAINTAINED ON APPEAL
1. Claims 2—5, 16, and 28—30 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Hansen ’433.2 Ans. 6.
2 Hansen et al., US 2003/0219433 Al, published Nov. 27, 2003.
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2. Claims 2—5, 7—14, 16, 28—30, and 32 stand rejected under 35
U.S.C. § 102(b) as anticipated by Hansen ’259.3 Ans. 9.
3. Claims 2—5, 15, and 16 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Tahir,4 as evidenced by Hansen ’433. Ans. 9.
4. Claims 2—5, 7—9, 11, 12, 15, and 16 stand rejected under 35
U.S.C. § 102(b) as anticipated by Morschhauser,5 as evidenced by
Hansen ’433. Ans. 10.
5. Claims 2—5, 7—14, 16, 28—30, and 32 stand rejected under 35
U.S.C. § 102(b) as anticipated by Smith.6 Ans. 10.
6. Claims 2—5, 7—16, and 28—32 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Hansen ’259, Tahir, and Morschhauser.
Ans. 11—12; see also Final Action 7.
DISCUSSION
We agree with, and adopt, the Examiner’s reasoning and conclusions
that the claims are anticipated and/or obvious over the cited prior art
references cited by the Examiner. We address Appellants’ arguments below.
3 Hansen et al., US 2007/0020259 Al, published Jan. 25, 2007.
4 Tahir et al., Humanized Anti-CD20 Monoclonal Antibody in the Treatment
of Severe Resistant Systemic Lupus Erythematosus in a Patient with
Antibodies against Rituximab (Letter to the Editor), 44 Rheumatology 561
(2005).
5 Morschhauser et al., Low Doses of Humanized Anti-CD20 Antibody, IMMU-
106 (hA20), in Refractory or Recurrent NHL: Phase //// Results (Meeting
Abstract), 25 J. Clinical Oncology (2007 ASCO Annual Meeting
Proceedings (Post-Meeting Edition) 8032 (2007).
6 Smith et al., US 2008/0089885 Al, published Apr. 17, 2008.
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A. Rejection 1
As relevant to exemplary claim 2, the Examiner finds that Hansen
’433 teaches the use of veltuzumab for the treatment of rheumatoid arthritis
(RA). Final Action 3. Veltuzumab, the Examiner explains, is a “hA20
humanized antibody[,] wherein said antibody is a substituted antibody of
claim 2 as per claim 15.” Id. The Examiner further finds that “hA20
inherently has the functional attributes recited in the claims because it is the
antibody recited in claim 15.” Id.
Appellants note that the rejected claims are drawn to a method, not a
product or composition (see Br. 3—4, 5), and rely on this distinction to argue
that:
A method as recited in claim 2 is not disclosed in Hansen ’433.
Therefore, the subject matter of claim 2 is novel over Hansen
’433. It does not matter whether a possible product of such
method, namely veltuzumab, is already known in the art. The
mere existence of a product which can be obtained by the
claimed method does not disclose or suggest such method claim
if the method as such is novel and based on an inventive step.
Id. at 6.
Appellants are correct that a known product can be the subject of a
patentable method claim. However, as the Examiner points out (see Ans. 7),
the inherency doctrine applies to method claims as well as product claims.
In affirming a district court’s judgment that a method claim was invalid, the
Federal Circuit explained inherency thusly:
a prior art reference may anticipate when the claim limitation or
limitations not expressly found in that reference are nonetheless
inherent in it. See In re Oelrich, 666 F.2d [578, 581 (CCPA
1981)]; Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d
628, 630, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). Under the
principles of inherency, if the prior art necessarily functions in
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accordance with, or includes, the claimed limitations, it
anticipates. See In re King, 801 F.2d 1324, 1326, 231 USPQ
136, 138 (Fed. Cir. 1986). Inherency is not necessarily
coterminous with the knowledge of those of ordinary skill in
the art. Artisans of ordinary skill may not recognize the
inherent characteristics or functioning of the prior art. See id.,
801 F.2d at 1326.
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999). Here, the Examiner finds that Hansen ’433 teaches the use of a
substituted antibody within the scope of claim 2 (i.e., veltuzumab) to treat a
disease within the scope of claim 2 (i.e., rheumatoid arthritis). The
“improving . . . [of] at least one characteristic ...” step of claim 2 would
have flowed necessarily from the claimed substitution; it is immaterial
whether one of ordinary skill in the art at the time of the invention would
have recognized the improvement. Appellants’ assertions of surprising
results (see Br. 6—7) are not germane to a § 102 rejection. See, e.g., In re
Malagari, 499 F.2d 1297, 1302 (CCPA 1974) (citing In re Wiggins, 488
F.2d 538 (CCPA 1973)).
Accordingly, the Examiner did not err in rejecting claim 2 as
anticipated by Hansen ’433. Claims 3—5, 16, and 28—30, which are not
argued separately, fall with claim 2. See 37 C.F.R. § 41.37(c)(l)(iv) (2014).
We affirm Rejection 1.
B. Rejections 2—4
Appellants repeat substantially the same arguments regarding
Rejections 2-4 as they advance regarding Rejection 1. Compare Br. 7—10
with Br. 4—7. These arguments are unpersuasive as applied to each of
Hansen ’259, Tahir, and Morschhauser for the reasons discussed with
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respect to Hansen ’433. See Final Action 4—6; see also Ans. 9-10.
Accordingly, we affirm Rejections 2-4.
C. Rejection 5
As applicable to exemplary claim 2, the Examiner finds:
Smith et al. teach a CDR3 substituted anti CD20 antibody [as]
recited in the claims (see [0124],[0357]) wherein the substituted
Asn in CDR3 is at position 101 of said antibody (aka the same
position in CDR3)). The antibody has the properties recited in
the claims (see [0106]). Smith et al. teach use of said antibody
to treat RA in combination with methotrexate (see [0269]).
Final Action 6.
Appellants compare SEQ ID NO:4 of Smith, which is discussed in the
passages cited by the Examiner, with the amino acid sequence for
veltuzumab. See Br. 11. According to Appellants, the number and nature of
the differences between SEQ ID NO:4 and veltuzumab mean that Smith
does not anticipate because (1) there are too many differences (Smith 1124
discloses sequences with “at least 85% sequence identity” with SEQ ID
NO:4) and (2) bridging the differences would require non-conservative
substitutions (contrary to the conservative amino acid substitutions discussed
in Smith 1124). See id. at 11—14.
The Examiner responds that the claims subject to Rejection 5 do not
specifically recite veltuzumab (i.e., claim 15 is not included in Rejection 5),
rendering Appellants’ veltuzumab-specific arguments beside the point, and
further notes that the claims do not “define the nature of the substituted
amino acid.” Ans. 11. We agree.
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As we are unpersuaded by Appellants’ arguments, we affirm the
Examiner’s rejection of claim 2 as anticipated by Smith. Claims 3—5, 7—14,
16, 28—30, and 32, which are not argued separately, fall with claim 2.
D. Rejection 6
1. Arguments Applicable to All Rejected Claims
In regard to claims 2—5, 7—16, and 28—32 generally, Appellants argue
solely by reference to their arguments presented for the § 102 rejections over
each of the Hansen references, Tahir, and Morschhauser, noting, inter alia,
that because Hansen ’259 (cited for this rejection) is a continuation
application based on Hansen ’433 (not cited for this rejection), “its
disclosure is identical.” Br. 15.
We have already dispensed with these arguments in the context of the
§102 rejections, as discussed above. Accordingly, we need not recite the
particulars of the § 103 rejection generally, except to state that we adopt the
Examiner’s findings and analysis as set forth on pages 7—9 of the Final
Action and as further explained in pages 11—13 of the Answer.
However, within Appellants’ discussion of the § 102 rejections, we
discern two arguments that are relevant primarily to the § 103 rejection
(though Appellants do not flag them as such or expressly reiterate them in
discussing Rejection 6). Neither is persuasive. Accordingly, for the reasons
of record and as explained further below, we affirm the Examiner’s § 103
rejection of claim 2. Claims 3—5, 7—16, 28—30, and 32, which are not argued
separately, fall with claim 2. We address claim 31, which Appellants argue
separately, following this more general analysis.
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a. Motivation to Combine
First, Appellants argue that Hansen ’433 (which, as noted above, has
the same disclosure as Hansen ’259) “provides no suggestion or reasonable
expectation” to the skilled artisan that the residue substitution at position 101
“would result in the functional changes recited in the claimed method.” Br.
5. Although inherency is more circumscribed in the context of obviousness
than anticipation, a disclosure is inherent for obviousness purposes if it is
“sufficient to show that the natural result flowing from the operation as
taught would result in the performance of the questioned function.” PAR
Pharm., Inc. v. TWIPharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014)
(quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). As discussed
above, here the “improving . . . [of] at least one characteristic . . .” step of
claim 2 would have flowed naturally from the use of veltuzumab to treat
rheumatoid arthritis described in Hansen ’433, whether the ordinarily skilled
artisan would have appreciated it or not.
b. Surprising Results
Second, Appellants address data regarding several hA20 variants in
their Specification, asserting that “it was surprisingly determined that
especially substitution at position 101 was of major importance for the
claimed method step of ‘improving by [substitution at position 101 of
CDR3] at least one characteristic ....’” Br. 6—7 (discussing Spec. ^fl[ 148,
255—274). To the extent Appellants are arguing that unexpected results
overcome the Examiner’s prima facie case of obviousness, this is not
persuasive because Appellants’ alleged surprising results relate to the
inherent characteristics or functioning of known prior art compositions.
Moreover, the burden of analyzing and explaining data to support
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nonobviousness rests with the Appellant. See In re Klosak, 455 F.2d 1077,
1080 (CCPA 1972). Appellants have failed to meet this burden. Appellants
include no convincing analysis or explanation of the data in their Brief that
establishes that the claimed invention provides unexpected results. Of the
paragraphs of the Specification flflf 148, 255—274) cited by Appellants, only
paragraph 148 discusses hA20 variants that differ from one another at
position 101. Appellants have not explained how paragraph 148 supports
the “surprising[]” importance of substitution at position 101, nor have they
directed us to any additional support.
2. Claim 31
Finally, Appellants present additional arguments regarding claim 31
specifically. Claim 31 is ultimately dependent on claim 2, and through its
multiple dependencies, “recites subcutaneous administration to treat
rheumatoid arthritis, wherein the human subject is refractory to rituximab,
and the therapeutic agent is methotrexate.” Br. 16. In rejecting claim 31,
the Examiner relies, inter alia, on Tahir and Morschhauser, as teaching the
use of veltuzumab in patients refractory to rituximab for the treatment of
SLE7 (in Tahir) and NHL8 (Morschhauser). See Final Action 8.
Appellants assert that the Examiner’s position in the obviousness
rejection, in relying on references that discuss treatment of SLE and NHL,
contradicts the Examiner’s position taken in regard to the restriction
requirement imposed earlier during prosecution of this application, which
required Appellants to elect “a specific disease.” See Br. 16; Restriction
Requirement (Dec. 2, 2011) 5. Appellants’ original claim 3 recited diseases
7 Systemic lupus erythematosus. Tahir 561.
8 Non-Hodgkin lymphoma. Spec. 147.
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including, inter alia, rheumatoid arthritis, SLE, and NHL. See Reply to
Requirement for Restriction and Election of Species (Jan. 3, 2012) 2—3.
Appellants elected rheumatoid arthritis. See id. at 6. Appellants now argue:
The basis given [in the restriction requirement] was that the
“these species are not obvious variants of each other based on
the current record.” Thus, it has been established on the record
that each of the diseases in applicant’s claims is a distinct
variant which would not have been obvious based on any of the
other diseases.
Br. 16.
This argument fails for two reasons. First, as the Examiner points out,
the restriction requirement was entered before the present prior art rejection.
Ans. 12. Accordingly, the cited references were not part of “the current
record” on which the restriction requirement was based, not the present
record; we discern no logical contradiction between the two. Second, the
Examiner’s rejection does not rely on SLE and NHL being obvious variants
of, or indistinct from, rheumatoid arthritis. Rather, the Examiner’s
obviousness analysis acknowledges that the diseases treated in Tahir and
Morschhauser (SLE and NHL, respectively) are “unrelated.” Final Action 8.
Indeed, the Examiner uses the fact of this unrelatedness as part of the
rationale for treating “any disease wherein use of anti CD 20 antibody
treatment of said disease was known in the art (aka RA) and wherein some
of the treated patients were refractory to treatment with rituximab.” Id.
As Appellants offer no other arguments or evidence for the
unpatentability of claim 31 specifically, we are unpersuaded the Examiner
erred in rejecting claim 31.
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CONCLUSION
The rejections of claims 2—5, 7—16, and 28—32 are affirmed. No time
period for taking any subsequent action in connection with this appeal may
be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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