Ex Parte Au et al

Board of Patent Appeals and Interferences

Oct 25, 2011

10807620 (B.P.A.I. Oct. 25, 2011)

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.
10/807,620 03/24/2004 Jessie L.-S. Au TNI -2-011 4039
266 7590 10/26/2011
MUELLER AND SMITH, LPA
MUELLER-SMITH BUILDING
7700 RIVERS EDGE DRIVE
COLUMBUS, OH 43235
EXAMINER
ANDERSON, JAMES D
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
10/26/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JESSIE L.-S. AU and M. GUILLAUME WIENTJES
__________

Appeal 2011-007036
Application 10/807,620
Technology Center 1600
__________

Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a kit
comprising suramin. The Examiner rejected the claims as lacking
description and as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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2
Statement of the Case
Background
“The present invention relates to a method to determine the dose
requirements of suramin used as a chemosensitizer to enhance the efficacy
of other chemotherapeutic agents.” (Spec. 1, ll. 18-20).
The Claims
Claims 27, 28, 32, 33, and 35 are on appeal. Claim 35 is the only
independent claim and reads as follows:
35. A kit for providing individual treatment of suramin to
a patient, comprising:
(a) not substantially in excess of about 800 mg of
suramin formulated in a pharmaceutical carrier; and
(b) a dosing nomogram to calculate the dose of
suramin for a patient based on the body surface area and the
timing of the treatment for said patient, whereby the dose is
calculated as the multiplication product of (squared value of
said patient's body surface area or BSA) and (numerical
value of a factor or FACTOR), in accordance to the
following table; said calculation comprising:
(b1) calculating the first treatment dose as the
multiplication product of (squared value of said patient's
BSA) and (125); and
(b2) calculating the second and subsequent doses as
the multiplication product of (squared value of said patient's
BSA) and (numerical value of FACTOR), wherein
FACTOR is determined by the elapsed days since last
suramin treatment
said nomogram table comprising:
Nomogram For Calculating Suramin Dose

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and whereby the dose for elapsed times not included in
the nomogram table, being less than 7 days or more than
55 days, is calculated in accordance to the following
equation:

Subsequent cycle dose (mg) = First dose * (1- e
-k·t
) =
125*BSA
2
*(1- e
-k·t
) Eq. 16

wherein
"BSA" is body surface area in units of m
2
,
"BSA
2”
is the squared value of BSA and is entered
as a unitless value,
"k" is the rate constant of decline of suramin
concentrations in plasma in units of 1/hour, and is 0.0026
1/hour,
"t" is time after suramin administration in units of hours.
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The Issues

A. The Examiner rejected claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement (Ans. 4-5).
B. The Examiner rejected claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Agyin
1
(Ans. 5-6).
C. The Examiner rejected claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Tu
2
and Agyin (Ans. 6-8).
D. The Examiner rejected claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Klohs
3
and Agyin (Ans. 8-10).
E. The Examiner rejected claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Lopez,
4
Klohs, and Agyin (Ans. 10-14).
A. 35 U.S.C. § 112, first paragraph – written description
The Examiner finds that the “claims are now drawn to a kit
comprising „not substantially in excess of about 800 mg of suramin‟
formulated in a pharmaceutical carrier” (Ans. 4). The Examiner finds that
“[t]here is no support, either explicit or implicit, for the claimed amount of
suramin. Nowhere do Appellants teach the claimed limitation of an amount
of suramin „not substantially in excess of about 800 mg‟ present in a kit”

1
Agyin et al., US 6,900,235 B1, issued May 31, 2005.
2
Tu et al., Phase I Study of Suramin Combined with Doxorubicin
in the Treatment of Androgen-independent Prostate Cancer, 4
CLINICAL CANCER RESEARCH 1193-1201 (1998).
3
Klohs et al., US 5,597,830, issued Jan. 28, 1997.
4
Lopez et al., The Synergistic and Antagonistic Effects of
Cytotoxic and Biological Agents on the In Vitro Antitumour Effects
of Suramin, 30A EUROPEAN J. CANCER 1545-1549 (1994).
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(Ans. 4). This rejection was identically presented in the Final Rejection (see
Final Rej. 7, 4/19/2010).
Appellants do not challenge the rejection of claims 27, 28, 32, 33, and
35 under 35 U.S.C. § 112, first paragraph, written description requirement in
the Appeal Brief. We therefore summarily affirm this rejection.
B.-E. 35 U.S.C. § 103(a) – obviousness
Because all of these rejections rely upon the Agyin patent and turn on
the same issue, we consider them together.
The Examiner finds that “Agyin et al. disclose benzimidazole
compounds for the treatment of cancers” (Ans. 5). The Examiner finds that
a “suitable potentiator is suramin as recited in claim 35” (Ans. 5). The
Examiner finds that “Agyin et al. disclose pharmaceutical kits for the
treatment of cancer comprising one or more containers containing a
pharmaceutical composition comprising a compound of the invention,
pharmaceutically acceptable carriers, and instructions” (Ans. 5).
Appellants contend that it “is material error to ignore printed
instructions in applying Section 103(a), even if the printed matter does not
constitute patentable subject matter” (App. Br. 15). Appellants contend that
the “the kit provides a new and unobvious functional relationship between
suramin and the printed instructions. That is, the printed instructions inform
the user that a patient must have a low dose of circulating suramin (< 200
µM) over the duration of 48 hours” (App. Br. 16). Appellants contend that
“the printed instructions provide an algorithm and the associated nomogram
table for the physician or pharmacist to use to calculate the proper dose of
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non-cytotoxic suramin for each patient based on criteria not taught by
Agyin, Tu, Klohs, or any other reference” (App. Br. 16).
Appellants contend that “Agyin discloses pharmaceutical kits and, due
to the broad description of kits in Agyin, such kits could even contain
suramin” (App. Br. 18). Appellants contend that “[h]owever, the kit of the
instant disclosure is not obvious over Agyin, as the printed matter, including
the dosing nomogram, is functionally related to the substrate of the kit
(suramin), and has a new and unobvious relationship to the substrate” (App.
Br. 18).
The issue with respect to this rejection is: Does the prior art render the
claims obvious?
Findings of Fact
1. Agyin teaches that a “„potentiator,‟ as used herein, is a material
that improves or increases the efficacy of the benzimidazole derivatives . . .
or that acts on the immune system as an immunomodulator. Potentiators can
be used in combination with a compound of the present invention” (Agyin,
col. 17, ll. 2-6).
2. Agyin teaches that potentiators include “suramin and analogues
thereof” (Agyin, col. 17, ll. 56-57).
3. Agyin teaches that:
Generally a dosage of as little as about 1-2 milligram (mg)
per kilogram (kg) of body weight is suitable, but preferably
as little as 10 mg/kg and up to about 10,000 mg/kg may be
used. Preferably, a dosage from 15 mg/kg to about S000
[sic, 5,000] mg/kg is used. Most preferably, the dose is
between 150 mg/kg to about 1000 mg/kg. Doses useful in
the treatment of cancer or viral infections are 250 mg/kg,
500 mg/kg, 800 mg/kg, 1000 mg/kg, 1500 mg/kg, 2500
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mg/kg, 3500 mg/kg, 4000 mg/kg, 5000 mg/kg, or 6000
mg/kg. Any range of doses can be used

(Agyin, col. 18, ll. 14-23).
4. Agyin teaches “pharmaceutical kits useful, for example, for the
treatment of cancer or viral infection. The kits comprise one or more
containers containing a pharmaceutical composition comprising a
therapeutically effective amount of a compound of the present invention or a
salt or a prodrug thereof” (Agyin, col. 24, ll. 7-12).
5. Agyin teaches that “[i]nstruction, such as e.g. printed
instructions either as inserts or as labels or the like, the instruction indicating
quantities of the components to be administered, guidelines for
administration, and/or guidelines for mixing the components, can also be
included with the kit” (Agyin, col. 24, ll. 17-22).
Principles 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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“Where the printed matter is not functionally related to the substrate,
the printed matter will not distinguish the invention from the prior art in
terms of patentability. Although the printed matter must be considered, in
that situation it may not be entitled to patentable weight.” In re Gulack, 703
F.2d 1381, 1385 (Fed. Cir. 1983).
Analysis
While Appellants dispute the Examiner‟s findings that the Agyin
suggests a kit which comprises suramin and instructions (App. Br. 18), we
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agree with the Examiner that Agyin teaches potentiators of cancer treatment
such as suramin (FF 1-3), which may be placed in a pharmaceutical kit (FF
4) that may include printed instructions (FF 5).
The central issue in dispute is whether, in the kit of claim 35, the
printed nomogram has a functional relationship with the pharmaceutical,
suramin.
In Ngai, the court confronted a similar fact pattern. Ngai claimed a kit
with reagents for performing a method and instructions on how the method
was to be performed. See In re Ngai, 367 F.3d 1336, 1337 (Fed. Cir. 2004).
The Ngai court concluded that “the printed matter in no way depends on the
kit, and the kit does not depend on the printed matter. All that the printed
matter does is teach a new use for an existing product.” Id. at 1339.
The same logic applies in the instant case since the nomogram in
claim 35 represents printed matter which does not functionally relate to the
suramin. These indicia of dosing represent printed matter which teach a
particular instruction set describing how to determine patient doses. As in
Ngai, if we were to adopt Appellant‟s position, anyone could continue
patenting a product indefinitely provided that they add new information to
the packaging of the product. See Ngai, 367 F.3d at 1339. That is, every
new method of dosing a drug could be reduced to written instructions which
could be included in a kit with the drug. However, while the new method
might properly be patented as a method claim, the product would differ from
the previous product only in the content of the instructions, the result
rejected by Ngai, 367 F.3d at 1339.
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This case is entirely unlike Gulack, where the printed matter was
integral to the operation of the device itself, resulting in a functional
relationship. In the instant case, dosing with the pharmaceutical compound
does not require the printed matter and there is no “functional relationship”
between the pharmaceutical suramin and the nomogram printed matter. See
In re Gulack, 703 F.2d 1381, 1386 (Fed.Cir.1983) (“The critical question is
whether there exists any new and unobvious functional relationship between
the printed matter and the substrate.”)
Conclusion of Law
The prior art renders the claims obvious.

SUMMARY
In summary, we summarily affirm the rejection of claims 27, 28, 32,
33, and 35 under 35 U.S.C. § 112, first paragraph as failing to comply with
the written description requirement.
We affirm the rejection of claims 27, 28, 32, 33, and 35 under 35
U.S.C. § 103(a) as obvious over Agyin.
We affirm the rejection claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Tu and Agyin.
We affirm the rejection claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Klohs and Agyin.
We affirm the rejection claims 27, 28, 32, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Lopez, Klohs, and Agyin.

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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

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