Ex Parte Rudy et al

Patent Trial and Appeal Board

Nov 15, 2012

11568506 (P.T.A.B. Nov. 15, 2012)

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.
11/568,506 10/30/2006 Susilo Rudy JCLA22273 5531
23900 7590 11/15/2012
J C PATENTS
4 VENTURE, SUITE 250
IRVINE, CA 92618
EXAMINER
SZNAIDMAN, MARCOS L
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
11/15/2012 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 RUDY SUSILO and EBERHARD AMTMANN
__________

Appeal 2011-006472
Application 11/568,506
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH,
Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
increasing the therapeutic efficacy of the cytostatic anticancer compound
temozolomide. The Examiner entered rejections for indefiniteness and
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 9-13 stand rejected and appealed (Ans. 2). Claim 9, the only
independent claim, illustrates the appealed subject matter and reads as
follows:
Appeal 2011-006472
Application 11/568,506

2
Claim 9. A method for increasing the efficacy of cytostatics,
comprising administrating an effective amount of
2-methylthiazolidine-2,4-dicarboxylic acid and/or physiologically
acceptable salts to a mammal in need thereof.

In response to a species election requirement, Appellants elected:
(a) temozolomide as the cytostatic compound having increased
efficacy, and
(b) small cell and non-small cell bronchial carcinoma, i.e. lung cancer,
as the species of treated disorder for prosecution on the merits (see Ans. 4;
see also Response to Restriction Requirement (entered April 21, 2008)).
Therefore, as to the merits of the art rejection, we limit our analysis
regarding the claimed process to the elected compound and disorder, and the
extent to which the appealed claims read on them. See Ex parte Ohsaka, 2
USPQ2d 1460, 1461 (BPAI 1987).
The following rejections are before us for review:
(1) Claims 9-13, under 35 U.S.C. 112, second paragraph, as indefinite
(Ans. 4); and
(2) Claims 9-13, under 35 U.S.C. § 103(a) as obvious over Susilo
1
and
Adonizio
2
(Ans. 4-8).
As Appellants direct no argument to the Examiner’s indefiniteness
rejection, we summarily affirm it. See MPEP § 1205.02 (“If a ground of

1
WO 01/60343 A2 (published August 23, 2001). In discussing the Susilo
reference, the Examiner cites to Susilo’s English language counterpart
publication, U.S. Patent No. 6,943,185 B2 (issued September 13, 2005). We
do the same.
2
Christian S. Adonizio et al., Temozolomide in Non-Small-Cell Lung
Cancer: Preliminary Results of a Phase II Trial in Previously Treated
Patients, 3 CLINICAL LUNG CANCER 254-258 (2002).
Appeal 2011-006472
Application 11/568,506

3
rejection stated by the examiner is not addressed in the appellant’s brief, that
ground of rejection will be summarily sustained by the Board.”).
OBVIOUSNESS
As evidence that the claimed process would have been obvious to an
ordinary artisan, the Examiner cited Susilo as teaching that the compound
recited in Appellants’ claims as increasing the efficacy of cytostatics,
2-methylthiazolidine-2,4-dicarboxylic acid (2-MTDC), was useful for
treating lung cancer, the elected species of treated disorder (Ans. 5). The
Examiner cited Adonizio as evidence that temozolomide, the elected species
of cytostatic, was also useful for treating lung cancer (id. at 6).
Based on these teachings, the Examiner reasoned that, because both of
the claimed agents were useful for treating the same disorder, an ordinary
artisan would have been prompted to co-administer them to treat that
disorder (see id. (citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980)).
The Examiner also reasoned that a “further motivation to combine 2-MTDC
and Temozolomide is the fact that according to Susilo, 2-MTDC reduces the
toxicity of cytostatics (i.e. Temozolomide)” (Ans. 6).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

Appellants’ arguments do not persuade us that a preponderance of the
evidence fails to support the Examiner’s conclusion that the claimed process
would have prima facie obvious to an ordinary artisan, nor are we persuaded
Appeal 2011-006472
Application 11/568,506

4
that the evidence of unexpected results advanced by Appellants is sufficient
to overcome the Examiner’s prima facie case.
In particular, we are not persuaded, as Appellants argue, that Susilo
teaches only that 2-MTDC was useful for reducing the side effects of other
cytostatic agents. While Susilo describes reducing side effects of cytostatics
as “[a]nother promising application” of 2-MTDC (see Susilo, col 2, l. 58
(emphasis added)), Susilo also discloses:
Animal tests proved that 2-methyl-thiazolidine-2,4-
dicarboxylic acid (2-MTDC) and/or its physiologically
tolerable salts can slow down or even stop the advance of
cancerous diseases.
These studies were conducted in several animal tumor
models. Test systems used were the mouse, the rat, and the
hamster. The objects of study included . . . pulmonary
adenocarcinomas . . . .

(Id. at col. 1, ll. 58-66.)
Thus, because Susilo teaches that 2-MTDC was useful not only for
ameliorating the side effects of cancer-treating cytostatic agents, but also
useful in and of itself for treating cancers such as lung cancer, and because
Adonizio teaches that temozolomide was also useful for treating lung cancer
(see Adonizio, abstract), we agree with the Examiner that an ordinary artisan
would have been prompted to co-administer 2-MTDC and temozolomide to
treat lung cancer as required by Appellants’ claims.
Appellants argue that the claims’ recitation, that the method is “for
increasing the efficacy of cytostatics” (App. Br. 9 (claim 9)), provides a
manipulative difference between the claims and the method of reducing side
effects suggested by Susilo (see id. at 5-6). We are not persuaded.
Appeal 2011-006472
Application 11/568,506

5
As noted above, Susilo suggests that 2-MTDC itself is useful as an
anticancer therapeutic (see Susilo, col. 1, ll. 58-66). Moreover, while
Appellants advance a number of ways a method of increasing the efficacy of
a cytostatic might differ from a method of ameliorating the side effects of a
cytostatic (see App. Br. 5-6), Appellants point to no specific evidentiary
support for those differences. More importantly, Appellants’ claims do not
limit the administration of the two drugs to any particular sequence or
technique which has been demonstrated as being different than that
suggested by the cited references.
As to Appellants’ evidence of unexpected results, we acknowledge the
Specification’s disclosure that, while 2-MTDC did not influence the growth
of the bladder cancer cell line “EJ,” 200 µg/ml 2-MTDC nonetheless
reduced the IC50 value of temozolomide against the EJ cells from 1053.36
µg/ml to 96.58 µg/ml (Spec. 15). We also acknowledge, as Appellants
argue, that 1000 µg/ml of 2-MTDC decreased the IC50 value of
temozolomide against EJ cells 67-fold (id. at 18).
We further acknowledge the statement in the Specification that
“[t]hese test data prove the unexpected increase of the efficacy of
combinations of a cytostatic with 2-methylthiazolidine-2,4-dicarboxylic acid
compared to the administration of a single cytostatic and the non existent or
low influence on the efficacy of a cytostatic or a cytotoxic or antiangiogenic
substance by N-acetylcysteine” (id. at 15).
As the Examiner points out, however, “the present species of cancer
under examination is lung cancer” (Ans. 13). Thus, the Examiner finds,
“Appellants have not set forth any reasoning as to how these results [in a
bladder cancer cell line] can be extrapolated to other cancer cell lines
Appeal 2011-006472
Application 11/568,506

6
including lung cancer (species under examination) since it is well known
that each type of cancer has its own etiology and pathophysiology” (id.).
We acknowledge that, although “[e]vidence of secondary
considerations must be reasonably commensurate with the scope of the
claims[,] . . . . [t]his does not mean that an applicant is required to test every
embodiment within the scope of his or her claims.” In re Kao, 639 F.3d
1057, 1068 (Fed. Cir. 2011).
Here, nonetheless, Appellants point to no evidence that an ordinary
artisan would have extrapolated to lung cancer, the species of disorder under
examination, the increased activity against bladder cancer cells of
temozolomide in the presence of 2-MTDC. Moreover, the Examiner’s
undisputed finding, that the activity of a cytostatic compound against one
cancer cell line cannot be extrapolated to another, is supported by the fact
that 2-MTDC has essentially no activity against the EJ bladder cancer cell
line, but has significant activity against the H4 neuroglioma cell line (see
Spec. 15 (“In the human gliomas cells H4, 2-methylthiazolidine-2,4-
dicarboxylic acid had a significant cytotoxic effect. An IC50 value of 9.66
µg/ ml was found.”)).
Thus, we find that a preponderance of the evidence supports the
Examiner’s position that the evidence of unexpected results advanced by
Appellants is not commensurate in scope with the claimed subject matter
under examination, and is therefore insufficient to rebut the Examiner’s
prima facie case of obviousness. Accordingly, we affirm the Examiner’s
rejection of claims 9-13 as obvious over Susilo and Adonizio.

Appeal 2011-006472
Application 11/568,506

7
SUMMARY
We affirm the Examiner’s rejection of claims 9-13 as indefinite.
We also affirm the Examiner’s obviousness rejection of claims 9-13
over Susilo and Adonizio.
TIME PERIOD
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

cdc