Ex Parte Bedrosian

Patent Trial and Appeal Board

Feb 16, 2016

11598850 (P.T.A.B. Feb. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111598,850 11/14/2006
104776 7590 02/18/2016
Ariad/Finnegan
901 New York Ave NW
Washington, DC 20001
FIRST NAMED INVENTOR
Camille L. Bedrosian
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.
11932.0002-00000 1558
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
02/18/2016 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):
regional-desk@finnegan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CAMILLE L. BEDROSIAN1
Appeal2013-006457
Application 11/598,850
Technology Center 1600
Before JEFFREYN. FREDMAN, ULRIKE W. JENKS, and
RICHARD J. SMITH, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
uECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method of administering the rapamycin analog AP23573 to a patient. The
Examiner rejects the claims as lacking written descriptive support and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellant, the Real Party in Interest is ARIAD
Pharmaceuticals, Inc. (App. Br. 1.)
Appeal2013-006457
Application 11/598,850
STATEMENT OF THE CASE
Claims 1 and 8-15 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1 is representative of the claims on
appeal, and reads as follows:
1. A method for administering AP23573 to a patient in need
thereof which comprises orally administering 40 mg of
AP23573 to the patient each day for four or five consecutive
days per week for at least two weeks.
(App. Br. 47, Claims Appendix.)
The Examiner rejects2 the claims as follows:
I. claims 11, 12, and 13 under 35 U.S.C. § 112, first paragraph as
containing new matter (Ans. 9);
II. claims 1 and 8-14 under 35 U.S.C. § 103(a) as unpatentable
over Metcalf;3 and
III. claims 1and8-15 under 35 U.S.C. § 103(a) as unpatentable
over Metcalf in view ofDancey.4
2 A non-statutory obviousness-type double patenting rejection over
copending U.S. Application No. 11/663,940 was made in the Final Action
mailed May 3, 2012 (Final Act. 16-17) and maintained in the Answer
(Ans. 21). U.S. Application No. 11/663,940 received a notice of
abandonment mailed Feb. 13, 2013. Accordingly, this rejection is moot.
3 Chester A. Metcalf III et al., US 2004/0073024 Al, published Apr. 15,
2004 (hereinafter "Metcalf').
4 Janet E. Dancey, Inhibitors of the mammalian target of rapamycin,
14 Expert Opin. Investig. Drugs 313-328 (2005).
2
Appeal2013-006457
Application 11/598,850
I. New Matter
The Examiner takes the position that the "'solid' dosage" form
limitation as recited in claims 11-13 was not sufficiently described in the
Specification as filed (see Final Act. 3). With respect to claim 13, the
Examiner additionally takes the position that the Specification does not
disclose the use of "'four 10 mg' dosage forms of any type" (see Final Act.
3).
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the recited limitations constitute new matter?
Findings of Fact
FPL The Specification discloses "[a] typical daily dose is from 2mg to 80 mg
of drug, e.g., 5---60 mg, or 10---50 mg, or 10---40 mg, or 10---30 mg." (Spec.
iT 11.)
FF2. Example 1 of the Specification describes a procedure "to prepare a tablet
containing 10 mg of AP23573." (Spec. iT 56.) "The milled, granulated
material was pressed into tablets using a tablet press set up with 6 mm
round concave tooling. The press was adjusted as required for a target
tablet weight of 125.0 mg, hardness of 5.5 kp [(kilopond)], friability no
more than 1 %, and disintegration time less than 10 minutes." (Spec. iT
59.)
FF3. Example 3 of the Specification details that "[a]dditional clinical studies
of AP23573 were conducted using a 0Dx5 dosing schedule for the
delivery of 30, 40 or 50 mg of AP23573/day." (Spec. iT 68.)
3
Appeal2013-006457
Application 11/598,850
Principle ofLaw
"The adequate written description requirement ... serves 'to ensure
that the inventor had possession, as of the filing date of the application relied
on, of the specific subject matter later claimed by him; how the specification
accomplishes this is not material.'" In re Alton, 7 6 F .3d 1168, 1172 (Fed.
Cir. 1996) (citation omitted). The amount of description needed to meet the
requirement can vary with the scientific and technologic knowledge already
in existence. Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). "It is
not necessary that the application describe the claim limitations exactly, but
only so clearly that one having ordinary skill in the pertinent art would
recognize from the disclosure that appellants invented processes including
those limitations." In re Herschler, 591F.2d693, 701(CCPA1979).
Analysis
Claim 13
Appellant directs our attention to Examples 1-3 of the Specification
as providing support for the limitation of 10 mg tablet and the administration
of multiples of 10 mg. (See generally Reply Br. 4; App. Br. 23.) Example 1
of the Specification "describes the preparation of 'a tablet containing 10 mg
of AP23573. "' (Reply Br. 4; App. Br. 23.) "The most reasonable
interpretation of Examples 1-3 of the specification is that the 10 mg tablets
prepared in Example 1 were used in the dose escalation studies of Examples
2 and 3." (Reply Br. 5; see also App. Br. 23.)
On this record, we find that Appellant has the better position. We find
that the Specification discloses administering the AP23573 composition at
varying dosage ranges (FFl). The Specification exemplifies the production
4
Appeal2013-006457
Application 11/598,850
of tablets containing a 10 mg dosage form AP23573 (FF2). We note that the
administration of the dosage form to patients as exemplified in the
Specification is in multiples of 10 (FF3). We agree with the Appellant's
position that a reasonable interpretation is that the administration of a 30, 40
or 50 mg dose to the patient is in the form of administering 3, 4, or 5 tablets
containing 10 mg of AP23573 each.
Accordingly, we reverse the rejection of claim 13 under 35 U.S.C.
§ 112, first paragraph as containing new matter.
Claims 11-13
We note that Appellant does not present separate argument with the
respect to the "solid dosage form" as recited in claims 11-13. (See Ans. 9.)
However, in the interest of fairness, we have considered the Examiner
position that the term "solid" "is a generic term that was not found upon
review of the specification." (Final Act 3.) On the record before us we find
that Examiner's position untenable. Here, the Specification discloses the
production of tablets having a hardness of 5.5 kp (FF2). The Examiner has
not explained why the description of a tablet with a hardness of 5.5 kp would
not be considered by the ordinary artisan to be a sufficient disclosure for the
term solid. See Herschler, 591 F.2d at 701.
Accordingly, we reverse the rejection of claims 11-13 under
35 U.S.C. § 112, first paragraph as containing new matter.
II. Obviousness over Metcalf
The Examiner finds that Metcalf discloses the claimed rapamycin
analog AP23573 and teaches that the rapamycin analog compounds
disclosed are promising agents for treating cancer. (Final Act. 6.) In
5
Appeal2013-006457
Application 11/598,850
addition, the Examiner finds that Metcalf also discloses treatment regimens
that render the claimed method obvious (see Final Act. 7-12).
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that Metcalf renders the claimed method of
administering AP23573 to patients obvious?
Findings of Fact
FF4. Metcalf discloses the production of dimethyl-phosphinic acid C-43
rapamycin ester. (Metcalf i-f 31 O; see also i1i1312-312; see Final Act. 6-
7, 12.)
FF5. Metcalf discloses a dosage range and administration regime for the
rapamycin analogs (rapalogs).
The effective systemic dose of the compound will typically be
in the range of about 0.01 to about 100 mg/kgs, preferably
about 0.1 to about 10 mg/kg of mammalian body weight,
administered in single or multiple doses. Generally, the
compound may be administered to patients in need of such
treatment in a daily dose range of about 1 to about 2000 mg per
patient. . . . [I]t may be administered daily for a period of days
(e.g. 2-10 days) followed by a period of days (e.g. 1-30 days)
without administration of the compound, with that cycle
repeated a given number of times, e.g. 4-10 cycles. As an
example, an anti-cancer compound of the invention may be
administered daily for 5 days, then discontinued for 9 days,
then administered daily for another 5 day period, then
discontinued for 9 days, and so on, repeating the cycle a total of
4-10 times.
(Metcalfi-f 281; see Final Act. 7.)
FF6. Metcalf discloses that pharmaceutical compositions containing the
rapamycin analog compounds encompasses tablets. (See Metcalf i-f 262.)
6
Appeal2013-006457
Application 11/598,850
FF7. Metcalf discloses that these rapamycin analogs
were tested for activity against a variety of cancer cell lines
were found to inhibit cancer cell growth and are therefore
useful as antineoplastic agents. In particular, the compounds of
this invention may be used alone or in combination with other
drugs and/ or radiation therapy in treating or inhibiting the
growth of various cancers, including leukemias and solid
tumors, including sarcomas and carcinomas, such as
astrocytomas, prostate cancer, breast cancer, small cell lung
cancer, and ovarian cancer.
(Metcalf i-f 215 (emphasis added).)
Principle 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."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
"[W]here the general conditions of a claim are disclosed in the prior
• • • • ,..J" t. . 1 t.1 t. . art, it iS not mventive to uiscover tue optimum or wori