Ex Parte BURGER

Patent Trial and Appeal Board

Sep 17, 2018

12879347 (P.T.A.B. Sep. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/879,347 09/10/2010
20277 7590 09/19/2018
MCDERMOTT WILL & EMERY LLP
The McDermott Building
500 North Capitol Street, N.W.
WASHINGTON, DC 20001
FIRST NAMED INVENTOR
Angelika BURGER
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.
075389-0013 6801
EXAMINER
CHOI, FRANK I
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
09/19/2018 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):
ipdocketmwe@mwe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANGELIKA BURGER
Appeal2017-005423
Application 12/879,347 1
Technology Center 1600
Before ULRIKE W. JENKS, TA WEN CHANG, and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of enhancing the efficacy of an anti-cancer agent selected from docitaxel and
paclitaxel in a patient suffering from docitaxel-resistant or paclitaxel-
resistant prostate cancer. The Examiner rejected the claims on appeal under
35 U.S.C. § 103(a) as obvious.
We affirm.
1 According to Appellant, the real party in interest is Kominox, Inc. Br. 2.
Appeal2017-005423
Application 12/879,347
STATEMENT OF THE CASE
The Specification discloses:
The major problem in developing effective and ultimately
curative treatments for cancer lies in the fact that cancers are
heterogeneous and contain mature cells as well as cells that are
responsible for self-renewal, termed stem cells. Current
cytotoxic anticancer agents are mainly aimed toward killing the
mature cell population, but can not eradicate cancer stem cells.
As a result, cancer often relapses and tumors then comprise
more aggressive stem cell-like drug resistant cancer cells
(Chumsri, S. et al., Curr. Opin. Mol. Ther. 10: 323-333, 2008).
Therefore, there is a need for new therapeutic agents and/or
regimens that can inhibit telomerase or target telomere to
reduce or eliminate both mature and stem-like cancer cells
including drug resistant cancer stem cells and mature cancer
cells.
Spec. ,r 4.
The Specification further discloses: "The present invention provides
methods and pharmaceutical compositions for preventing, treating, reducing,
or eliminating cancer cells; more particularly the present invention provides
a prophylactically and/or therapeutically effective amount or regimen of
sodium meta arsenite for reducing or eliminating cancer stem cells and drug
resistant cancer cells." Id. ,r 2.
Claims 1, 9, 11, and 22 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A method of enhancing the efficacy of an anti-cancer
agent selected from docitaxel and paclitaxel in a patient
suffering from docitaxel-resistant or paclitaxel-resistant prostate
cancer, said method comprising administering to the patient a
unit dose of from 0.1 to 20 mg of sodium meta arsenite one or
more times a day and a therapeutically effective amount of the
anti-cancer agent.
2
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Application 12/879,347
App. Br. 10 (Claims App'x).
The Examiner rejected claims 1, 9, 11, and 22 under 35 U.S.C.
§ I03(a) as obvious over the combination of Ellison,2 Hawley's, 3 and EP
1721615.4
FINDINGS OF FACT
1. Sodium arsenite is also called sodium metaarsenite. Hawley's
1137; see also App. Br. 3 n.1.
2. The Examiner finds, and Appellant does not dispute, that taxol
is also called paclitaxel. Ans. 7.
3. EP 1 721615 discloses that "there are three chemotherapy drugs
approved by the U.S. Food and Drug Administration for use in prostate
cancer-Taxotere® ( docetaxel), Novantrone® (mitoxantrone hydrochloride)
and Emcyt® (estramustine sodium phosphate)." EP 1721615 ,r 34.
4. EP 1721615 discloses:
Accordingly, the present invention provides a
pharmaceutical composition intended for the treatment of
urogenital diseases and bone metastasis in a human, wherein
said pharmaceutical composition contains an effective amount
of arsenous acid alkaline or earth alkaline metal salt and/or a
pharmaceutically acceptable adjuvant.
According to the present invention, said alkaline
arsenous acid metal salt is sodium meta-arsenite (As02Na) or
potassium meta-arsenite (As02K).
Id. ,I,I 41--42.
5. EP 1721615 discloses:
Surprisingly, oral arsenous acid sodium salt showed a
2 Ellison et al., US Patent No. 6,875,451 B2, issued Apr. 5, 2005 ("Ellison").
3 HAWLEY'S CONDENSED CHEMICAL DICTIONARY 1137 (15th ed. 2007)
("Hawley's).
4 Lee et al., EP 1 721 615 Al, published Nov. 15, 2006 ("EP 1721615").
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Appeal2017-005423
Application 12/879,347
high therapeutic efficacy in cancer patients suffering from
urogenital cancer, mainly prostate and bone metastasis,
following treatment with 2.5, 10, 12.5, 15, 17.5 and 20 mg of
arsenous acid sodium salt capsules for 14 consecutive days.
Surprisingly the patients all tolerated the arsenous acid
sodium salt extremely well with no adverse events (AE's) or
serious adverse events (SAE's) occurring.
Id. ,I,I 52-53.
6. EP 17216165 discloses:
The compounds of the invention may be used alone or in
combination. Additionally the treated compounds may be
utilised with other types of treatments. For example, the subject
compounds may be used with other chemotherapies e.g.
tamoxifen, taxol, methothrexate, biologicals such as antibodies,
growth factors or lymphokines, radiation etc. Combination
therapies may result in synergistic results. The preferred
indication is cancer especially the cancers identified previously.
Id. ,I 88.
7. EP 1721615 discloses examples in which patients suffering
from prostate cancer "not amenable to any established methods of therapy"
were effectively treated with arsenous acid sodium salt at seven different
dosing levels with "no adverse events" and a "high level of efficacy." Id. ,r,r
99-129 (quoted phrases drawn from ,r,r 99, 105).
8. Ellison discloses:
the present invention relates to novel chemotherapeutic
methods-novel uses of arsenic compounds for treating primary
and metastatic tumors; primary and metastatic tumors of the
central nervous system; refractory primary and metastatic
tumors of the central nervous system; breast, lung, bladder and
prostate cancer; and refractory breast, lung, bladder and prostate
cancer to mention a few.
Ellison, col. 1, 11. 17-24.
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Application 12/879,347
9. Ellison discloses: "The arsenic compound of the invention may
be utilized in ... a variety of known forms. . . . The inorganic salt forms of
arsenic are preferred. For example ... sodium arsenite ... may be used."
Id. at col. 8, 11. 48---60.
10. Ellison discloses:
In accordance with the present invention, arsenic compounds
can be used alone or in combination with other known
therapeutic agents (including chemotherapeutics,
radioprotectants and radiotherapeutics) or techniques to either
improve the quality of life of the patient, or to treat the primary
neoplastic disease. For example, the arsenic compounds can be
used before, during or after the administration of one or more
known antitumor agents including but not limited to ...
taxol.
Id. at col. 6, 11. 36-47.
ANALYSIS
In concluding that claims 1, 9, 11, and 22 would have obvious, the
Examiner found that Ellison disclosed that "arsenic compounds, such as
sodium arsenite, can be used to treat refractory primary and metastatic
tumors of the prostate ... including remission thereof' and that the arsenic
compounds could be administered "before, during or after chemotherapeutic
agents, such as taxol and cisplatin." Final Act. 5 3--4. The Examiner
acknowledged, however, that Ellison did not expressly disclose treatment of
prostate cancer which is resistant to docetaxel or paclitaxel. Id. at 4.
The Examiner found that EP 1721615 disclosed that "oral sodium
meta-arsenite is well tolerated and has greater therapeutic and safety
advantages in comparison with arsenic trioxide." Id. EP 1721615 further
5 Office Action mailed April 20, 2016 ("Final Act.").
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Application 12/879,347
disclosed that sodium meta arsenite could be used to treat prostate cancer
which is resistant to traditional chemotherapy drugs and that sodium meta
arsenite may be used with other chemotherapies, such as taxol. Id.
Based on the combined disclosures ofEP 1721615, the Examiner
concluded that claimed method would have been obvious and that the skilled
artisan would reasonably have expected "that sodium meta arsenite would
enhance the activity of docetaxel and paclitaxel against prostate cancer
which is resistant to docetaxel or paclitaxel." Id. at 5.
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-7; Final Act. 3-8) and agree that
the claims are obvious over Ellison, Hawley's, and EP 1721615. We
address Appellant's arguments below.
Appellant argues that "[ t ]he combination of cited prior art fails to
provide a reasonable basis for an expectation of success in treating docetaxel
or paclitaxel resistant prostate cancers with a combination of sodium meta
arsenite and docetaxel or paclitaxel." App. Br. 3. We are not persuaded.
Ellison and EP 1721615 both teach the use of sodium meta arsenite to
treat prostate cancer. FFl, FF4, FF5, FF8, FF9. Ellison teaches that sodium
meta arsenite can be used to treat refractory prostate cancer- i.e. cancer that
does not respond to treatment. FF8. Similarly, EP 1721615 discloses
examples in which patients suffering from prostate cancer not amenable to
any established methods of therapy were effectively treated with arsenous
acid sodium salt. FF7. Appellant fails to direct us to persuasive evidence
demonstrating that docitaxel-resistant and paclitaxel-resistant prostate cancer
differ materially from "refractory prostate cancer." Accordingly, we find
that the skilled artisan would reasonably have expected that a compound that
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Application 12/879,347
taught to be effective in treating "refractory prostate cancer" and prostate
cancer that was "not amenable to any established methods of therapy" - i.e.
sodium meta-arsenite - would also be effective in treating docitaxel-resistant
or paclitaxel-resistant prostate cancer.
In addition, both Ellison and EP 1721615 teach that sodium meta-
arsenite may be used in combination therapy with other therapeutic agents.
Both Ellison and EP 1721615 specifically identify taxol - i.e. paclitaxel
(FF2)- among the therapeutic agents that can be used in combination their
inventive arsenic compounds. FF6, FF 10. 6 This provides reason to
administer sodium meta-arsenite in combination with paclitaxel.
Appellant argues that the cited publications "do not suggest that
sodium meta arsenite reverses taxane resistance of cancer cells, enabling use
of both drugs ( sodium meta arsenite and the taxane) to treat the resistant
forms of prostate cancer using lower effective concentration of each drug."
App. Br. 3. We are not persuaded because, as discussed above, the prior art
discloses that sodium meta arsenite would be effective to treat prostate
cancers which are resistant to treatment (FF7, FF8), and suggests
administering sodium meta arsenite in combination with other therapies,
including paclitaxel. FF2, FF6, FFlO. As the Examiner explained, the
advantage of reversing resistance to docetaxel and paclitaxel "would flow
naturally from following the suggestion in the art to treat prostate cancer
which is resistant to paclitaxel and docetaxel with the combination of
sodium meta arsenite and paclitaxel or docetaxel." Ans. 5.
6 EP 1 721615 suggests that combination therapy "may result in synergistic
results." FF6.
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Application 12/879,347
Appellant argues that the record shows that "taxane resistance poses a
significant challenge in the treatment of prostate cancer" and that even so,
"taxanes remain the gold standard for treatment of prostate cancer." App.
Br. 4 (citing Madan,7 Abstract). Accordingly, Appellant argues, "there is a
long felt need for therapies that overcome taxane resistance of prostate
cancer cells." Id. We are not persuaded.
We acknowledge that Madan identifies a "need to overcome taxane
resistance in prostate cancer." Madan, Abstract. This statement
notwithstanding, we are not persuaded that Madan supports the existence of
a long felt need because Madan also teaches, inter alia, that "[t]herapeutic
combinations have ... been employed to overcome taxane resistance in
prostate cancer." Madan 3 897; see also id. at Abstract ("[p ]reliminary
evidence suggests that several treatment strategies may improve the activity
of taxanes in prostate cancer and perhaps enhance clinical outcomes").
Additionally, Madan was published after Appellant's Application was filed.
Appellant does not provide evidence that the purported need identified in
Madan was recognized at the time of Appellant's invention.
To the extent there was a need to overcome taxane resistance at the
time of Appellant's invention, Ellison, and EP 1721615 address that need.
Ellison and EP 1721615 disclose that sodium meta-arsenite can be used to
treat refractory prostate cancer and prostate cancer that was not amenable to
any established methods of therapy. FF7, FF8. As discussed above,
Appellant has not directed us to persuasive evidence suggesting that
7 Ravi A. Madan et al., Overcoming Chemotherapy Resistance in Prostate
Cancer, 17(12) CLIN. CANCERRES. 3892, 3902 (2011) ("Madan"). Madan
was cited by Appellant as evidence supporting a long felt need.
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Application 12/879,347
docetaxel and paclitaxel resistant cancer would not be among the refractory
cancers taught to be treatable with sodium meta-arsenite. More specifically,
Appellant has not provided persuasive evidence or argument explaining why
Ellison and EP 1 71615 do not address the purported need to overcome
taxane resistance in prostate cancer. See Newell Companies, Inc. v. Kenney
Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) ("[o]nce another supplied the
key element, there was no long-felt need or, indeed, a problem to be
solved."). Accordingly, we are not persuaded that a long felt need
demonstrates the non-obviousness of the claimed method.
Appellant argues that unexpected results demonstrate the non-
obviousness of the claimed method. According to Appellant, the Kim8 and
Hussain9 Declarations show that:
not only is drug resistance reversed by sodium meta arsenite,
but the taxane-resistant prostate cancer cells are killed by the
combination of sodium meta arsenite and the taxane at a
surprisingly and significantly lower effective dose of each of
the drugs in the combination than is required of each drug when
used alone to treat wild type or resistant cells.
App. Br. 6. We are not persuaded because we agree with the Examiner that
the prior art provides a "general expectation of synergistic activity." Ans. 5;
see also FF6. Particularly in view of this general expectation, Appellant has
8 Declaration of Dr. Su jong Kim, signed October 23, 2014 ("Kim Deel.").
The record includes a second Kim declaration, signed October 6, 2014,
however, this Declaration relates to treatment of lung cancer cells with
sodium meta-arsenite. Appellant does not explain the relevance of this
declaration to the present claims, which are directed to treatment of prostate
cancer.
9 Declaration of Dr. Arif Hussain, signed December 19, 2011 ("Hussain
Deel.").
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Application 12/879,347
not provided persuasive evidence that the results described in the Kim and
Hussain Declarations would have been unexpected.
In addition, the claimed method requires administering a dose of "0.1
to 20 mg of sodium meta arsenite one or more times a day" to a patient
together with a "therapeutically effective amount" docetaxel or paclitaxel.
The Kim and Hussain Declarations describe administration of a 50%, 75%,
and 90% of an effective dose to cultured prostate cancer cells. AppeUant
does not explain how the dosages tested in the experiments described in the
Kim and Hussain Declarations c01Telate with the claimed dosage. Nor does
Appellant explain why the results from testing performed on a cell culture
establish unexpected results for administration "to the patient" as claimed.
Accordingly, the proffered evidence of unexpected results is not
commensurate with the scope of the claims.
DECISION
For these reasons and those set forth in the Examiner's Answer and
Final Office Action, we affirm the Examiner's rejection of claims 1, 9, 11,
and 22 under 35 U.S.C. § 103(a) as obvious over the combination of Ellison,
Hawley's, and EP 1721615.
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 ). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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