Ex Parte Edelstam

Patent Trial and Appeal Board

Jun 19, 2017

13698730 (P.T.A.B. Jun. 19, 2017)

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.
13/698,730 01/25/2013 Greta Edelstam 4007636-191850 8051
23570 7590 06/21/2017
PORTER WRIGHT MORRIS & ARTHUR, LLP
INTELLECTUAL PROPERTY GROUP
41 SOUTH HIGH STREET
29TH FLOOR
COLUMBUS, OH 43215
EXAMINER
SZNAIDMAN, MARCOS L
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
06/21/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GRETA EDELSTAM
Appeal 2016-006358
Application 13/698,7301
Technology Center 1600
Before ERIC B. GRIMES, TAWEN CHANG and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating endometriosis. The Examiner rejected the claims on appeal under
35 U.S.C. § 103(a) as obvious.
We reverse.
1 According to Appellant, the real party in interest is Isifer AB. App. Br. 1.
Appeal 2016-006358
Application 13/698,730
STATEMENT OF THE CASE
Claims 26, 28—31, and 3AA0 are on appeal. Claim 26 is illustrative
and reads as follows:
26. A method of treating endometriosis in a person suffering
from inflammation due to endometriosis and having an
endometriosis implant, by reducing a cytokine MCP-1 related
activity level of the endometriosis implant in said person by
70% or more while not affecting a corresponding TNF-a related
activity level by more than 20%, comprising intraperitoneally
administering a pharmaceutical composition comprising
lidocaine hydrochloride and a pharmaceutically acceptable
aqueous balanced salt solution to said person, wherein the
pharmaceutical composition is administered by injection or
infusion into the peritoneal cavity and wherein the
pharmaceutical composition comprises from 0.8 mg/ml to 2.5
mg/ml of lidocaine hydrochloride and is administered into the
peritoneal cavity in an amount of from 5 ml to 20 ml.
App. Br. 22.
The Examiner rejected claims 26, 28—31, and 3AA0 under 35
U.S.C. § 103(a) as obvious over Edelstam.2
2 Edelstam, EP 1 158 978 Bl, published Dec. 5, 2001 (“Edelstam”).
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Appeal 2016-006358
Application 13/698,730
ANALYSIS
In finding claims 26, 28—31, and 34-40 obvious over Edelstam, the
Examiner found that Edelstam disclosed a method of treating endometriosis
by intraperitoneally administering a pharmaceutical composition comprising
an effective amount of lidocaine and a pharmaceutically acceptable salted
aqueous carrier, Ans. 2—3. The Examiner acknowledged that Edelstam did
not teach administration of lidocaine in the amounts recited in the claims,
but found that the claimed amounts would have been obvious because the
amount of lidocaine that Edelstam taught to administer was “close to the
amounts and volumes of the instant claims.” Id. at 3.
Appellant argues that claims 26, 30, 31 and 34 require “at the least,
twice the maximum dosage disclosed by Edelstam and up to 25 times the
maximum dosage of Edelstam.” App, Br, 6. Appellant further argues that
claims 28, 29, and 35-40 require higher dosages than claims 26, 30, 31 and
3 and thus differ even more from the dosage disclosed by Edelstam. Id. at
11—21. Appellant contends that there is “no teaching or suggestion by
Edelstam to employ such high amounts of lidocaine hydrochloride, or to
increase the amount of lidocaine above the maximum amount of 2 mg (2000
pg) mentioned by Edelstam, particularly to treat endometriosis” and that
Edelstam’s dosage is not close enough to the claimed dosage to support a
finding of obviousness. Id. at 6 and 10.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
“[T]he examiner bears the initial burden ... of presenting a prima facie case
of unpatentability.” Appellant has persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
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Appeal 2016-006358
Application 13/698,730
Claims 26, 30, 31 and 34 require that a “pharmaceutical composition
comprising] from 0.8 mg/ml to 2.5 mg/ml of lidocaine hydrochloride ... is
administered into the peritoneal cavity in an amount of from 5 ml to 20 ml.”
As Appellant points out, the concentration and amount recited in these
claims results in a total dosage of 4.0 mg to 50.0 mg of lidocaine
hydrochloride. App. Br. 6. The other claims on appeal require a higher
minimum total dosage of lidocaine hydrochloride.
Edelstam discloses:
The concentration is one that has an effect on infertility of a
woman or one that increases the fertility of a woman. The dose
and concentration may be decided by the physician. The
concentration of the effective substance is at least 5 jig/ml. One
may use 100-2000 pg in 1—20 ml, preferably about 118 pig. The
dose that is administrated is at least 100 pg and preferably
about 1000 pg.
Edelstam 113. As Appellant points out, the concentration and amount
disclosed in Edelstam results in a total dosage of 0.1 to 2.0 mg of lidocaine.
App. Br. 6.
The Examiner relies on Titanium Metals Corp. of America v. Banner,
778 F.2d 775 (Fed. Cir. 1985), and related cases to establish aprima facie
case of obviousness based on the closeness of the recited dosage. See, Ans.
3—4, 20-27. The lidocaine dosage taught by Edelstam, however, is at least 2
and potentially 25 times less than the dosage recited by the claims. We
agree with Appellant that this difference is too great to support a prima facie
case of obviousness under Titanium Metals.
The Examiner finds “reason to increase the amount of lidocaine
hydrochloride” based on the fact that “[d]ose optimization is routine practice
in the pharmaceutical art” and that Edelstam states “the dose and
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Appeal 2016-006358
Application 13/698,730
concentration may be decided by the physician.” Ans. 18. This is not
persuasive because, in context, Edelstam’s statement that the physician may
determine the dose is followed by a statement identifying a range of doses,
thus suggesting that the physician should determine a dose within the
identified range. See Edelstam 113 (quoted above). As the Examiner does
not identify any other teachings in Edelstam or otherwise provide reason to
increase the lidocaine dosage significantly from the maximum dosage taught
by Edelstam, we reverse the Examiner’s decision to reject claims 26, 28—31,
and 34-40.
SUMMARY
For the reasons set forth herein, we reverse the Examiner’s decision to
reject claims 26, 28—31, and 34-40 under 35 U.S.C. § 103(a) as obvious
over Edelstam.
REVERSED
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