Ex Parte Caligiuri et al

Patent Trial and Appeal Board

Mar 17, 2015

11629638 (P.T.A.B. Mar. 17, 2015)

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.
11/629,638 12/20/2007 Maureen G. Caligiuri GPCI-P01-206 6464
7590 03/17/2015
Leon R. Yankwich, Esq.
Yankwich & Associates, P.C.
201 Broadway
Cambridge, MA 02139
EXAMINER
RICCI, CRAIG D
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
03/17/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MAUREEN G. CALIGIURI, NIKOLAI A. KLEY, and
KRISHNA K. MURTHI
1

__________

Appeal 2012-007499
Application 11/629,638
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, CHRISTOPHER G. PAULRAJ, and
ROBERT A. POLLOCK, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Final Rejection
dated October 14, 2010. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
“The present invention describes the novel uses of compounds that are
known as potent inhibitors of the class of enzymes known as cyclin-
dependent kinases (CDKs).” Spec. 3:21–23. “It was surprisingly observed
that the molecules shown by the general formulae below, initially found to

1
Appellants identify the Real Party in Interest as Agennix USA, Inc. (App.
Br. 3.)
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2
be CDK inhibitors, had not only a broad range of CDK inhibitory activity,
but also an inhibitory activity to a variety of other kinases, and even to
disease-associated mutants of such kinases.” Id. at 27–30. “Thus these
kinase inhibitors can be effective in the treatment of diseases associated with
these other, non-CDK kinases.” Id. at 3:31–4:1.
“[T]he inhibitors of this invention are capable of inhibiting a large
number of non-CDK kinases which are involved in a variety of disease
conditions including cancer. Thus such compounds would be useful for
treating subjects having disorders associated with excessive cell
proliferation, such as hyperplasia or cancer.” Id. at 14:11–15. In one
embodiment, the invention relates to “a method of treating a warm-blooded
animal having leukemia, comprising administering to the animal at least one
subject kinase inhibitor compound to inhibit the activity of a member of the
Src kinase family, . . . or the activity of a member of the Btk or Tec kinase
family, in a quantity which is therapeutically effective against leukemia.”
Id. at 39:15–20.
The claims on appeal depend, directly or indirectly from independent
claims 4 and 115 set forth below:
4. A method for the treatment of a cancer or tumor that is
hematological or comprises or is derived from blood cells,
said method comprising administration of a compound or a
pharmaceutical composition comprising said compound,
wherein the compound has the formula:

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or a tautomeric, pharmaceutically-acceptable salt or
stereoisomeric form thereof thereof [sic], and wherein said
pharmaceutical composition optionally comprises a
pharmaceutically-acceptable carrier.

115. A method of treating a disease or disorder, comprising
the administration of a compound having the formula:

or a tautomeric, pharmaceutically acceptable salt, or
stereoisomeric form thereof, wherein said treatment is
mediated and/or effected by inhibiting a kinase that is not a
cyclin-dependent kinase.
The following grounds of rejection are before us for review:
I. The Examiner rejects claims 4, 51, and 52 under 35 U.S.C. § 102(e) as
anticipated by Bockovich.
2

II. The Examiner rejects claims 4, 36, 43, 44, 51, 52, 57, 59, 60, 115–134,
137, and 139–141 as unpatentable under 35 U.S.C. § 103(a) over the
combination of Nugiel
3
as evidenced by Schlaifer
4
and Verrills.
5

2
Bockovich et al., WO 2004/092139 A2, published October 28, 2004.
3
Nugiel et al., US 2001/0027195 A1, published October 4, 2001.
4
Daniel Schlaifer et al., Myeloperoxidase: An Enzyme Involved in Intrinsic
Vincristine Resistance in Human Myeloblastic Leukemia, 81 BLOOD 482–89
(1993).
5
Nicole M.Verrills et al., Proteomic Analysis Reveals a Novel Role for the
Actin Cytoskeleton in Vincristine Resistant Childhood Leukemia: An In Vivo
Study, 6 PROTEOMICS 1681–94 (2006) (Abstract only).
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III. The Examiner rejects claims 39–42 as unpatentable under 35 U.S.C.
§ 103(a) over the combination of Nugiel, as evidenced by Schlaifer and
Verrills, and applied to claims 4, 36, and 51, above, and further in view
of Stefankova,
6
Hirose,
7
and Dong.
8

ANALYSIS
35 U.S.C. § 102(e)
We have reviewed Appellants’ contentions that the Examiner erred in
rejecting claim 4, and its dependent claims 51 and 52, as anticipated by
Bockovich under 35 U.S.C. § 102(e). App. Br. 6–7. With respect to this
rejection, we disagree with Appellants’ conclusions and adopt as our own
the factual findings and analysis set forth at pages 5 and 15–16 of the
Examiner’s Answer. For emphasis, we highlight and address the following:
Bockovich teaches the use of cyclin-dependent kinase (CDK)
inhibitor compounds including B16 for the treatment of cancer or other
proliferative diseases (Bockovich, Abstract, 1:5–9, 20:22–27, Table A at
139) including “leukemia, acute lymphocytic leukemia [ALL], acute
lymphoblastic leukemia, B-cell lymphoma, T-cell lymphoma, Hodgkins

6
Z. Stefankova et al., Overcoming of P-Glycoprotein Mediated Vincristine
Resistance of L1210/VCR Mouse Leukemic Cells Could be Induced by
Pentoxifyline But Not by Theophylline and Caffeine, 43 NEOPLASMA 11–15
(1996) (Abstract only).
7
Masao Hirose et al., Expression Level of G1-Cyelins and Cell Proliferation
in Human Cultured Leukemia/Lymphoma Cell Lines, 12 INT’L J. ONCOLOGY
841–46 (1998).
8
Youyi Dong et al., Cyclin D1-CDK4 Complex, A Possible Critical Factor
for Cell Proliferation and Prognosis in Laryngeal Squamous Cell
Carcinomas, 95 INT. J. CANCER (PRED. ONCOL.) 209–15 (2001).
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lymphoma, non-Hodgkins lymphoma . . . and chronic myelogenous
leukemias [CMLs].”
Appellants contend that the Examiner errs in rejecting claims 4, 51
and 52 under 35 U.S.C. § 102(e) because Bockovich presents no data
“directing a person skilled in the art to use compound B16 in treatments for
cancers that are not CDK-mediated cancers,” and thus, the claimed methods
“are not supported” by the Bockovich disclosure. App. Br. 7. We do not
find Appellants’ argument persuasive.
Claim 4 is drawn to a method of treating cancer or a tumor derived
from blood cells by administering the compound B16. The dependent
claims at issue specify the cancer as, “leukemia, lymphoma, Hodgkin’s
disease, or non-Hodgkin’s lymphoma” (claim 51), “chronic myelogenous
leukemia (CML) or acute lymphoblastic leukemia (ALL)” (claim 52).
Applying the broadest reasonable interpretation consistent with Appellants’
Specification, we do not interpret claims 4, 51, and 52 as limited to the
treatment of only non-CDK-mediated cancers. See Broadcom Corp. v.
Qualcomm Inc., 543 F.3d 683, 689 (Fed. Cir. 2008) (“‘When the claim
addresses only some of the features disclosed in the specification, it is
improper to limit the claim to other, unclaimed features.’”) (quoting Ventana
Med. Sys., Inc. v. Biogenex Labs., Inc., 473 F.3d 1173, 1181 (Fed. Cir.
2006)). Accordingly, we agree with the Examiner that:
While not conceding to the argument that “[a]ny method of
treatment that is taught by the Bockovich reference contains
the inherent limitation that the disease to be treated must be
mediated by CDKs”, even if it were the case that the
disclosure of Bockovich et al was so limited, it is noted that
the features upon which Applicant relies (i.e., the treatment
of diseases which are not mediated by CDKs) are not recited
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by the rejected claims. Although the claims are interpreted in
light of the Specification, limitations from the Specification
are not read into the claims.
Ans. 16 (citing In re Van Geuns, 988 F.2d 1181 (Fed. Cir. 1993)); See also
In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments fail
from the outset because . . . they are not based on limitations appearing in
the claims.”).
35 U.S.C. § 103(a)
In rejecting 4, 36, 39–44, 51, 52, 57, 59, 60, 115–134, 137, and 139–
141 as unpatentable under 35 U.S.C. § 103(a), the Examiner relies on Nugiel
as suggesting Compound B16 in the treatment of cancer. Ans. 7–10, 14–22.
In particular, the Examiner points to Nugiel paragraph 0477 and Nugiel
claim 36 as disclosing a compound (“0477”) structurally related to
Compound B16 but having “(1) an extra –CH2– group between the phenyl
and piperazinyl group and (2) a methoxy group further substituting the ethyl
substituent of the piperazinyl group.” Ans. 7–8. The Examiner contends
that it have been obvious to select 0477 as a lead compound; modify it by
including a single –CH2– linking group between the phenyl and piperazine
ring; and further modify it by substituting the piprazinyl ethyl group with
methoxy. Id. at 8–10. According to the Examiner, one of ordinary skill in
the art would have been motivated to make the two modifications “in order
to make a compound having similar properties with a reasonable expectation
of success.” See id. at 9–10.
The Federal Circuit provides a two-prong analysis to determine
whether a new chemical compound is prima facie obvious over particular
prior art. The fact finder first determines whether a chemist of ordinary skill
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would have selected the asserted prior art compounds as lead compounds, or
starting points, for further development efforts. Otsuka Pharm. Co., Ltd. v.
Sandoz, Inc., 678 F.3d 1280, 1291 (Fed. Cir. 2012). The analysis begins
with the identification of “a compound in the prior art that would be most
promising to modify in order to improve upon its . . . activity and obtain a
compound with better activity,” Takeda Chem. Indus., Ltd. v. Alphapharm
Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007), or “a natural choice for
further development efforts.” Altana Pharma AG v. Teva Pharms. USA,
Inc., 566 F.3d 999, 1008 (Fed. Cir. 2009). The second step involves
determining “whether the prior art would have supplied one of ordinary skill
in the art with a reason or motivation to modify a lead compound to make
the claimed compound with a reasonable expectation of success.” Otsuka,
678 F.3d at 1292 (citing Takeda, 492 F.3d at 1357).
For the purpose of this appeal, we need only address the first prong of
the analysis. The Examiner contends that 0477 qualifies a lead compound
because it is “is specifically identified in Claim 36 among only 19 other
compounds,” and is thus, “an obvious starting point for optimization.” Ans.
17. The Examiner identifies no other reason for selecting 0477 from among
the thousands of compounds taught by the reference, nor any reason for
selecting 0477 from among the 20 listed in claim 36.
The genus of Nugiel claim 1 encompasses thousands, if not millions,
of possible compounds, and Nugiel claim 35 recites 286 specific compounds
within the scope of claim 1. As Appellants point out, the Nugiel
specification does not provide functional data for 0477, or otherwise suggest
that it provides any benefit or special property as compared to the many
other compounds within the scope of the reference’s disclosure. See Reply,
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7. Thus, while we recognize the possibility that there can be “one or more
lead compounds,” Otsuka, 678 F.3d at 1291, we need not opine on whether a
claim, standing alone, may sufficiently identify 0477 as one of 20 possible
lead compounds. See also Altana, 566 F.3d at 1008 (“to the extent Altana
suggests that the prior art must point to only a single lead compound for
further development efforts, that restrictive view of the lead compound test
would present a rigid test similar to the teaching-suggestion-motivation test
that the Supreme Court explicitly rejected in KSR [Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 419 (2007)]”). In the context of the reference as a whole, we
do not find the Examiner’s focus on Nugiel claim 36 sufficiently identifies
0477 as a lead compound.
We, therefore, agree with Appellants that the Examiner’s
identification of 0477 as a lead compound for the development of
Compound B16 is based on improper use of hindsight. See, e.g., App. Br. 9.
Because the Examiner does not point to Schlaifer, Verrills, Stefankova,
Hirose, and/or Dong as supplying the missing element, we reverse.
SUMMARY
I. We affirm the rejection of claims 4, 51, and 52 under 35 U.S.C.
§ 102(e) as anticipated by Bockovich.
II. We reverse the rejection of claims 4, 36, 43, 44, 51, 52, 57, 59, 60,
115–134, 137, and 139–141 as unpatentable under 35 U.S.C. § 103(a)
over the combination of Nugiel as evidenced by Schlaifer and
Verrills.
III. We reverse the rejection of claims 39–42 as unpatentable under
35 U.S.C. § 103(a) over the combination of Nugiel, as evidenced by
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Schlaifer and Verrills, and applied to claims 4, 36, and 51, above, and
further in view of Stefankova, Hirose, and Dong.

TIME PERIOD FOR RESPONSE
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–IN–PART
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