Ex Parte Miller

Board of Patent Appeals and Interferences

Nov 24, 2010

10318659 (B.P.A.I. Nov. 24, 2010)

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.
10/318,659 12/12/2002 Richard A. Miller 25922-716.201 8345
21971 7590 11/24/2010
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
11/24/2010 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 RICHARD A. MILLER
____________

Appeal 2009-011751
Application 10/318,659
Technology Center 1600
____________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON REHEARING1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304 begins to run from the “MAIL
DATE” shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-011751
Application 10/318,659

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Appellant requests a rehearing (“Req. Reh’g”) under 37 C.F.R. §
41.52(a)(1) of the Decision mailed July 8, 2010 (“Decision” or “Dec.”) in
which we set forth a new ground of rejection of claims 1-25 as obvious
under 35 U.S.C. § 103(a).

STATEMENT OF THE CASE
Pursuant to 37 C.F.R. § 41.50(b), we entered a new ground of
rejection of claims 1-25 under 35 U.S.C. § 103(a) as obvious in view of
Viala (Dec. 3). Claim 1 was selected as representative and reads as follows:
1. A method for delaying neurologic progression in a human
afflicted with lung cancer comprising administering to the
human about 5.0 mg/kg to about 10 mg/kg of a compound of
Formula I [as reproduced on page 22 of the Appeal Brief].
Appellant contends certain facts, as discussed in more detail below,
were misapprehended in making the rejection on new grounds (Req. Reh’g
3).

Patients with brain metastases due to lung cancer
Appellant contends that we misapprehended Viala with respect to the
number of patients in the study with brain metastases due to lung cancer as
the primary cancer (Req. Reh’g 3).
Findings of Fact 3 and 42 are as follows:
3. Patients admitted to Viala’s study had brain metastases
([Viala] at 756, first column, lines 5-12). “Eleven patients . . .
were enrolled in this study. Ten patients had already undergone
treatment for a tumor: three for breast cancer, five for lung

2 The Findings of Fact (“FF”) referenced in this Decision on Rehearing
appear on pages 5-6 of the Decision.
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cancer, one for thyroid cancer and one for skin cancer
(melanoma).” (Id. at 756, third column.)
4. “One patient had brain metastases, which revealed a lung
cancer.” [Viala, p. 756, col. 3, second full paragraph.]
Appellant acknowledges that FF3 and FF4 are factually correct, but
contends that “Viala does not include any discussion regarding the primary
cancer for the brain metastases of the patients in the study.” (Req. Reh’g 3).
Appellant states, as far as FF4, there is “[a]rguably, a high probability
. . . that the brain metastases were due to lung cancer as a primary cancer in
the one patient where the brain metastases revealed a lung cancer.” (Id.)
However, Appellant contends this conclusion is not the same for the five
patients described in FF3 (id. at 4).
Claim 1 is to a “method for delaying neurologic progression in a
human afflicted with lung cancer” comprising administering the Formula I
compound. The claim does not require that the human have a brain
metastasis due to a lung cancer as the primary cancer. Rather, the claim
requires the human to be “afflicted with lung cancer.” At least the patient in
Finding of Fact 4 had a lung cancer. The patient also had brain metastases
(FF4). “The Specification reported that the Formula I compound improved
neurological function selectively in patients with lung cancer where the lung
cancer had metastasized to the brain (Spec. 2:12-17)” (Dec. 7). Because
Viala performed the same step of administering a Formula I compound to
the same patient class as recited in claim 1, it is reasonable to believe that
the neurologic progression was delayed, as well, shifting the burden to
Appellant to show that it was not (id. at 7-9). Appellant did not provide
evidence to the contrary. Appellant did not establish that even if the brain
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metastases did not arise from the lung cancer a different result would have
been expected.

Doses administered
Appellant contends that the Board misapprehended the doses
administered to patients in Viala’s study. Appellant acknowledged that FF5
and FF11 “are not factually incorrect,” but contend “a more correct
statement for FF5 and FF11 would have been:
5. Doses of gadolinium texaphyrin were from 0.5 µmol/kg to
4.10 µmol/kg, with two out of eleven patients receiving the
highest dose (id. at 756-757).
***
11. The dose of 4.10 µmol/kg of the Formula I compound
administered in two out of eleven instances by Viala is
equivalent to 4.70844 mg/kg calculated as follows:
1148.40 gms/mole x 4.10 µmol/kg = 4.70844 mg/kg.”
(Req. Reh’g 5). The underlined phrases were added by Appellant to make
the factual findings “more correct.” (Id.)
Appellant contends “the Board does not have sufficient evidentiary
support for an assertion that any lung cancer patient in Viala’s study in fact
received a 4.70844 mg/kg dose of a compound of Formula I.” (Id. at 6.)
We agree with Appellant as to “corrected” factual findings 5 and 11,
and modify our Decision to incorporate these changes. However, such
changes do not alter the determination that the subject matter of claim 1
would have been obvious to persons of ordinary skill in the art.
In reaching our obviousness determination in the Decision, it was not
necessary that the patient “in fact received a 4.70844 mg/kg dose of a
compound of Formula I.” (Req. Reh’g 6.) The basis of the rejection was
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not anticipation under 35 U.S.C. § 102, but obviousness under 35 U.S.C. §
103. Consequently, the standard was not whether Viala described the
claimed subject matter in the manner required by section 102, but whether
the claimed method would have been reasonably suggested to a person of
ordinary skill in the art by Viala’s disclosure.
Our obviousness determination was based on the closeness in values
between the claimed dose and the highest dose of Viala, and the lack of
evidence that the dosages were critical to achieve the claimed delay in
neurological progression (Dec. 7-9). While the value of 4.70844 mg/kg may
not have been administered to a patient with lung cancer, it is close to the
highest value disclosed in Viala. Persons of ordinary skill in the art would
have had reason to administer the Formula I compound in a dose of “about 5
mg/kg” to a lung cancer patient with brain metastases in view of Viala’s
teaching of the compound’s benefits for this class of patients (FF7 & FF8;
Dec. 8).

Inherency & delay in neurological progression
Appellant contends that the Decision did not establish that a lung
cancer patient received a dose in the claimed range (Req. Reh’g 8).
Appellant stated: “Even using multiple assumptions that are not literally
supported by Viala, the probabilities do not rise to 100% certainty” to
“establish inherency” (id.).
We have already addressed this issue above. Our obviousness
determination was not based on the fact that a lung cancer patient had
received a dose within the claimed range, but rather was centered on the
obviousness of administering such a dose.
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As to whether Viala inherently accomplished a delay in neurological
progression, this issue was fully addressed in the Decision (Dec. 7-10).
Appellant has not pointed to any error in the facts set forth in the Decision or
provided evidence that persons of ordinary skill in the art would have
doubted that Viala’s method involving the same compound, same patient,
and same manipulative steps would have resulted in a delay in neurological
progression as required by claim 1.

SUMMARY
We grant this Request for Rehearing to the extent of accepting
Appellant’s suggested changes to Findings of Fact 5 and 11 of the Decision
mailed July 8, 2010. However, we decline to modify the Decision that
claims 1-25 are obvious under 35 U.S.C. § 103(a) in view of Viala.

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).

GRANTED-IN-PART

KMF

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WILSON, SONSINI, GOODRICH & ROSATI
650 Page Mill Road
Palo Alto, CA 94304-1050