Ex Parte Brooks-Korn

Patent Trial and Appeal Board

Sep 17, 2012

10367386 (P.T.A.B. Sep. 17, 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.
10/367,386 02/14/2003 Howard Brooks-Korn 01172.0002.NPUS01 2961
7590 09/17/2012
David A. Lowin
Chemin de la Viane 37
Le Mont-sur Lausanne, CH1052
SWITZERLAND
EXAMINER
CHONG, YONG SOO
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
09/17/2012 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 HOWARD BROOKS-KORN
__________

Appeal 2011-005869
Application 10/367,386
Technology Center 1600
__________

Before LORA M. GREEN, MELANIE L. McCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 38-41.
1

We have jurisdiction under 35 U.S.C. § 6(b).

1
Claims 11, 12, 15, 16, 28, and 29 are also pending, but stand withdrawn
from consideration (App. Br. 6).
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STATEMENT OF THE CASE
Claims 1 and 39 are the independent claims on appeal, and read as
follows:
1. A method for treating paresis/paralysis resulting from a neurologic or
neurogenic disorder comprising administering to a subject in need thereof an
effective amount of an opioid compound.

39. A method for treating paresis/paralysis resulting from a neurogenic
disorder comprising administering to a subject in need thereof an effective
amount of an opioid compound.

The claims have also been subject to an election of species, and have
only been examined to the extent they read on the use of oxycodone for
treating laryngeal paresis/paralysis (App. Br. 8).

The following grounds of rejection are before us for review:
I. Claims 1, 3, 13, 14, 23, 26, 27, 30-32, 34, and 39-41 stand
provisionally rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over
claims 1-5, 7-14, and 19 of USSN 11/395,200 (Ans. 3).
II. Claim 38 stands rejected under 35 U.S.C. § 112, first paragraph, as
containing new matter (Ans. 4).
III. Claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39-41 stand rejected
under 35 U.S.C. § 103(a) as being rendered obvious by Borsodi,
2

Johnson,
3
and Longer
4
(Ans. 5).

2
Borsodi et al., US 5,317,022, issued May 31, 1994.
3
Johnson et al., US 5,393,545, issued Feb. 28, 1995.
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IV. Claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39-41 stand rejected
under 35 U.S.C. § 103(a) as being rendered obvious by Lalley,
5

Johnson, and Longer (Ans. 7).
We affirm-in-part.

ANALYSIS
Rejection I
As Appellant does not argue the merits of the obviousness-type
double patenting rejection, we summarily affirm it.

Rejection II
The Examiner rejects claim 38 under 35 U.S.C. § 112, first paragraph,
as containing new matter (Ans. 4). According to the Examiner, “claim 38
recites the negative limitation „neurologic disorder is other than morphine
toxicity,‟” finding that “[t]here is no clear support in the specification for
this negative limitation” (id.).
Appellant argues that the rejection is inconsistent with the case law, as
it is “essentially premised upon the position that one skilled in the art would
read Applicant‟s disclosure as teaching that morphine toxicity-induced
respiratory depression should be treated by administering more morphine”
(App. Br. 13).
We agree with Appellant, and thus reverse the rejection.

4
Mark A. Longer, PhD and Joseph R. Robinson, PhD, in REMINGTON‟S
PHARMACEUTICAL SCIENCES 18
th
Ed., pgs. 1676-1682 (1990).
5
Lalley, US 6,706,704 B2, issued Mar. 16, 2004.
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Rejection III
The Examiner rejects claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39-
41 as being rendered obvious by Borsodi, Johnson, and Longer (Ans. 5).
The Examiner finds that Borsodi teaches a preparation for treating
respiratory depression (Ans. 5). Specifically, the Examiner finds that
Borsodi teaches “that oxycodone and dihydrocodeinone derivatives of
general formula I can inhibit the respiratory depression in rats caused by
morphine, which in turn is attributed to respiratory paralysis (col. 3, lines 17-
47)” (id.). Thus, according to the Examiner, Borsodi discloses “the
compound oxycodone as recited in col. 3, line 18 of the Borsodi patent” (id.
at 9).
The Examiner relies on Johnson for teaching “that nervous disorders
lead to larynx paralysis, which can lead to respiratory paralysis,” and Longer
for teaching “advantages of administering a drug using sustained release
drug therapy” (id. at 6).
Appellant argues:
Borsodi discloses that certain derivatives of oxycodone and
dihydrocodeinone can be used as analgesics without the
appearance of lethal respiratory depression. Borsodi discloses
analgesics; not a biologically active preparation for human or
veterinary use for treating respiratory depression. Borsodi
teaches that oxycodone potentiates the toxicity of morphine; not
that oxycodone can inhibit the respiratory depression in rats
caused by morphine.

(App. Br. 12.)
Specifically, Appellant asserts that oxycodone is not a compound
taught as having utility in the method of Borsodi, but it is compounds of
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Formula I of Borsodi that have utility, which are different from oxycodone
(id. at 15-17). According to Appellant, the Examiner has misinterpreted the
teachings of Borsodi at col. 3, ll. 17-47 of the patent (id. at 17-18).
Appellant asserts that in fact, Borsodi teaches that oxycodone potentiates
morphine toxicity-induced respiratory depression (id. at 21 (citing Borsodi,
col. 3, l. 66-col. 4, l. 3 and col. 9, ll. 13-15).
We agree with Appellant that the combination of Borsodi, Johnson,
and Longer does not render the claimed method as it reads on the use of
oxycodone for treating laryngeal paresis/paralysis obvious.
Borsodi teaches that “[i]t is known that the morphine-like analgetics
(opiates) act as respiratory-depressants” (Borsodi, col. 1, ll. 18-19).
According to Borsodi:
We have found surprisingly that oxycodone and
dihydrocodeinone derivatives of general formula (I) are
irreversible inhibitors or a dose-dependent manner of specific
binding of (
3
H)naloxone at isotope concentrations of 1 nM and
they have a lower affinity to the (
3
H)naloxone binding sites as
compared with the corresponding morphine derivatives.

(Id. at col. 3, ll. 18-24.)
The Examiner reads that to mean that Borsodi teaches that oxycodone,
as well as dihydrocodeinone derivatives of general formula (I) are
irreversible inhibitors or a dose-dependent manner of specific binding of
(
3
H)naloxone. We agree with Appellant, that in the context of the reference
as a whole, a better reading is oxycodone derivatives of general formula (I)
as well as dihydrocodeinone derivatives of general formula (I).
For example, Borsodi teaches that the invention is drawn to “a
biologically active composition for selective blocking of the opiate binding
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sites of the bra[i]n which are responsible for respiratory depression, which
contains codeinone derivatives of the general formula (I) or its salts in a
biologically active quantity” (id. at col. 1, ll. 4-9).
Borsodi then refers to dihydrocodeinone and oxycodone as “„mother
compounds.‟” Specifically, Borsodi teaches:
It has to be mentioned that amongst the referred “mother
compounds” dihydrocodeinone and oxycodone cause
respiratory depression in 50-2500 μg/kg and 10-2500 μ/kg s.c.
doses. Both compounds unambiguously potentiate the
respiratory depression effect of morphine.

(Id. at col. 3, l. 66-col. 4, l. 3.)
Thus, the ordinary artisan would understand that oxycodone is not
useful for inhibiting respiratory depression caused by morphine, but in fact
potentiates the respiratory depression effect of morphine. Therefore,
contrary to the findings of the Examiner, Borsodi does not teach the use of
oxycodone for inhibiting respiratory depression. As neither Johnson nor
Longer make up that deficiency of Borsodi, we reverse Rejection III.

Rejection IV
The Examiner rejects claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39-
41 as being rendered obvious by Lalley, Johnson, and Longer (Ans. 7).
The Examiner finds that Lalley teaches that a “pharmaceutical
composition comprising oxycodone can inhibit respiratory depression (col.
2, lines 17-30) in mammals including humans, cats, and dogs (col. 7, lines
42-67)” (id.).
The Examiner relies on Johnson and Longer as set forth above.
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Appellant argues:
Lalley discloses two-component pharmaceutical compositions
comprising an opiate or opioid and a D1-dopamine receptor
agonist that is effective to inhibit the respiratory depression of
the opiate or opioid; not that a “pharmaceutical composition
comprising oxycodone can inhibit respiratory depression.”

(App. Br. 12.) Appellant argues that Lalley in fact teaches that oxycodone
causes respiratory depression (id. at 30 (citing Lalley, col. 2, ll. 17-30)).
We again agree with Appellant that the combination of Lalley,
Johnson, and Longer does not render the claimed method as it reads on the
use of oxycodone for treating laryngeal paresis/paralysis obvious.
Lalley is drawn to a “method of inducing opioid analgesia and
anesthesia in mammals, including humans, without suppressing respiration”
(Lalley, col. 1, ll. 1-12).
Specifically, Lalley teaches
[A] pharmaceutical composition for inducing analgesia or
anasthesia in a mammalian subject, while simultaneously
eliminating or inhibiting respiratory depression in the subject.
The pharmaceutical composition comprises, in combination, an
opiate or opioid analgesic or anesthetic, a D1-dopamine receptor
agonist, and a pharmaceutically-suitable carrier therefor. More
specifically, in the preferred composition, the opiate or opioid
is selected from the group consisting of … oxycodone, …; and
the D1-dopamine receptor agonist is selected from the group
consisting of ….

(Id. at col. 2, ll. 17-44 (emphasis added).)
Thus, in the method of using the composition, Lalley teaches that the
opiates or opioids induce respiratory depression, which is inhibited through
the use of a D1-dopamine receptor agonist (id. at col. 2, ll. 45-55).
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Thus, the ordinary artisan would understand that oxycodone is not
useful for inhibiting respiratory depression, but in fact induces respiratory
depression when used to induce analgesia or anesthesia in a mammal.
Therefore, contrary to the findings of the Examiner, Lalley does not teach
the use of oxycodone for inhibiting respiratory depression. As neither
Johnson nor Longer make up that deficiency of Lalley, we reverse Rejection
IV.

SUMMARY
We affirm the provisional rejection of claims 1, 3, 13, 14, 23, 26, 27,
30-32, 34, and 39-41 under the judicially created doctrine of obviousness-
type double patenting as being unpatentable over claims 1-5, 7-14, and 19 of
USSN 11/395,200.
We reverse the rejection of claim 38 under 35 U.S.C. § 112, first
paragraph, as containing new matter; the rejection of claims 1-3, 13, 14, 17-
23, 26, 27, 30-34, and 39-41 under 35 U.S.C. § 103(a) as being rendered
obvious by Borsodi, Johnson, and Longer; and the rejection of claims 1-3,
13, 14, 17-23, 26, 27, 30-34, and 39-41 under 35 U.S.C. § 103(a) as being
rendered obvious by Lalley, Johnson, and Longer.

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).

AFFIRMED-IN-PART
Appeal 2011-005869
Application 10/367,386

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