Ex Parte Gelotte et al

Patent Trial and Appeal Board

Dec 15, 2016

12796889 (P.T.A.B. Dec. 15, 2016)

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.
12/796,889 06/09/2010 Cathy K. Gelotte MCP0325USDIV1 3773
27777 7590 12/19/2016
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
COLEMAN, BRENDA LIBBY
ART UNIT PAPER NUMBER
1624
NOTIFICATION DATE DELIVERY MODE
12/19/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CATHY K. GELOTTE,
DOUGLAS R. HOUGH, and GERARD P. MCNALLY
Appeal 2015-004403
Application 12/796,889
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving a method of
administering a non-steroidal anti-inflammatory drug. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as McNeil-PPC, Inc., a
wholly owned subsidiary of Johnson & Johnson (see Br. 2; we number the
pages, unnumbered in the brief, in consecutive order).
Appeal 2015-004403
Application 12/796,889
Statement of the Case
Background
Applicants have now discovered that NSAID’s or
acetaminophen provided to a mammal, preferably a human, in a
specific, two step dosing regimen provide improved therapeutic
effect, especially pain relief, compared with known dosing
regimens. In particular, an NSAID or acetaminophen is
provided to the mammal, either in one dosage form or two
dosage forms taken separately, in an initial dose followed by a
second dose of about 3 to 5 hours later. No further NSAID or
acetaminophen need be provided, yet surprisingly the
therapeutic effect of the NSAID acetaminophen lasts at least
about 6 hours after administration of the second dose.
(Spec. 2:11-18).
The Claims
Claims 1, 3, 5—8, 11—17, 24—27, 30—32, and 35—37 are on appeal.
Independent claim 1 is representative and reads as follows:
1. A method of administering a non-steroidal anti­
inflammatory drug, which consists of providing to a mammal a
dosage form comprising an initial dose of an immediate release
portion containing said non-steroidal anti-inflammatory drug
and a second dose of a delayed burst release portion containing
said non-steroidal anti-inflammatory drug that is released about
4 hours after administration of said initial dose, said non­
steroidal anti-inflammatory drug having a duration of
therapeutic effect which lasts at least about 6 hours after
administration of said second dose, wherein said initial dose is
at least about twice said second dose.
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Appeal 2015-004403
Application 12/796,889
The Issue
The Examiner rejected claims 1, 3, 5—8, 11—17, 24—27, 30-32, and
35—37 under 35 U.S.C. § 103(a) as obvious over Odidi,2 Palmisano,3
Ameer,4 and Roberts5 (Ans. 2—3).
The Examiner finds that Palmisano teaches “treatment of pain
associated with dysmenorrhea with a loading dose of 800 mg of ibuprofen
followed by maintenance dosages of 400 mg of ibuprofen” and Odidi
teaches “pulsatile delivery of pharmaceutically active agents” (Ans. 2). The
Examiner finds it obvious “to formulate ibuprofen in a pulsatile dosage form
of Odidi and Odidi with an initial dosage of 400 mg and at least one
subsequent dosage of 200 mg based on the disclosure of Palmisano and
Lamb” (Ans. 2—3). The Examiner relies upon Ameer to teach
acetaminophen and Roberts to teach “that ibuprofen should be administered
every 4 to 6 hours” (Ans. 3).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the prior art renders the
claims obvious?
2 Odidi et al., US 6,607,751 Bl, issued Aug. 19, 2003 (“Odidi”).
3 Palmisano et al., Double-Blind Crossover Comparison of Ketoprofen,
Ibuprofen, and Placebo in the Treatment of Patients with Primary
Dysmenorrhea, 5 Advances in Therapy 128—137 (1988) (“Palmisano”).
4 Ameer et al., Acetaminophen, 87 Annals Internal Medicine 202—209
(1977) (“Ameer”).
5 Roberts et al., Analgesic-Antipyretic and Antiinflammatory Agents and
Drugs Employed in the Treatment of Gout, in Goodman & Gilman’s The
Pharmacological Basis of Therapeutics 687, 704, 711 (2001)
(“Roberts”).
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Application 12/796,889
Findings of Fact
1. Palmisano teaches:
patients received ketoprofen, ibuprofen, and placebo during
three consecutive menstrual cycles. Each patient was randomly
assigned to one of six possible treatment sequences by means of
a Latin-square design. The first (loading) dose during each
menstrual cycle was 150 mg of ketoprofen (two 75-mg
capsules), 800 mg of ibuprofen (two 400-mg tablets) or
placebo. To maintain double-blind conditions, all patients
received a total of two capsules and two tablets, some of which
were matched placebos, depending on the active treatment. The
patients were instructed to take the trial medication only when
the pain intensity became moderate or severe. Subsequently,
the patients were permitted to take up to four 75-mg doses of
ketoprofen or four 400-mg doses of ibuprofen daily for up to 3
days. Patients were urged to wait at least 3 hours before taking
the second dose or at least 2 hours before taking a “rescue”
analgesic provided by the investigator.
(Palmisano 130).
2. Palmisano teaches, in Table 1, the mean remedication times for
ketoprofen were 6.4 hours and 6.1 hours for ibuprofen (see Palmisano 132,
Table 1).
3. Palmisano teaches
It is unlikely that the high loading doses used in this study
contributed much to the therapeutic success. The earlier studies
of ketoprofen in dysmenorrhea were performed with 50-mg
doses, repeated three or four times within 24 hours;
comparisons of three dose levels (25, 50, and 100 mg) in single­
dose studies of ketoprofen in postpartum pain showed little if
any difference in the analgesic response, with all three doses
significantly superior to placebo and aspirin (650 mg).
(Palmisano 136, citations omitted).
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Application 12/796,889
4. Odidi teaches “[pjulsatile delivery is achieved by making a unit
dose such as a capsule containing a plurality of tablets or population of
granules which release the active agent at different rates or at different time
intervals” (Odidi 5:1—4).
5. Odidi teaches “[sjuitable pharmaceuticals for use in the device
include . . . ibuprofen” (Odidi 3:13—18).
6. Ameer teaches “[ajcetaminophen (paracetamol, N-acetyl-para-
aminophenol) is commonly used as a mild analgesic and antipyretic”
(Ameer 202, col. 1).
7. Roberts teaches treatment with ibuprofen and “[f]or mild-to-
moderate pain, especially that of primary dysmenorrhea, the usual dosage is
400 mg every 4 to 6 hours as needed” (Roberts 711, col. 2).
Principles of Law
A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was
taken by the applicant. The degree of teaching away will of
course depend on the particular facts; in general, a reference
will teach away if it suggests that the line of development
flowing from the reference’s disclosure is unlikely to be
productive of the result sought by the applicant.
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Analysis
While we can agree with the Examiner that Palmisano teaches a
loading dose of pain medication that may, in some patients, be followed
several hours later by a lower amount “rescue” dose when pain reaches
moderate or severe levels (FF 1), Palmisano specifically teaches “[i]t is
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Appeal 2015-004403
Application 12/796,889
unlikely that the high loading doses used in this study contributed much to
the therapeutic success” (FF 3). This is not a situation where the prior art
could not have synthesized an ibuprofen tablet with pulsatile delivery as
taught by Odidi, but rather a situation where Palmisano discourages the use
of a higher loading dose (FF 3), and the Examiner has advanced no
persuasive positive reason to overlook Palmisano’s discouragement and do
so. We therefore agree with Appellants that “this statement leads one skilled
in the art to view Palmisano et al. as teaching away from the administration
of a higher initial dose” (Br. 7).
We recognize the Examiner’s contention that “additional doses of
ibuprofen or acetaminophen may be warranted” (Ans. 5). However,
Palmisano and Roberts do not provide a reason to use a higher loading dose
followed by a second, lower dose four hours later as required by claim 1.
Moreover, because Palmisano specifically indicates that only patients with
pain should remedicate (FF 1) and Roberts also teaches that medication
should be taken only “as needed” (FF 7), the ordinary artisan would be led
away, based on the evidence of record here, from combining two doses into
a single dose because that would automatically remedicate patients whether
the second dose was needed or not.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the prior art renders the claims obvious.
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Application 12/796,889
SUMMARY
In summary, we reverse the rejection of claims 1, 3, 5—8, 11—17, 24—
27, 30-32, and 35—37 under 35 U.S.C. § 103(a) as obvious over Odidi,
Palmisano, Ameer, and Roberts.
REVERSED
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