Ex Parte Krumme et al

Patent Trial and Appeal Board

Feb 9, 2017

11391646 (P.T.A.B. Feb. 9, 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.
11/391,646 03/28/2006 Markus Krumme 512100-2055 4198
20999 7590 02/13/2017
FROMMER LAWRENCE & HAUG
745 FIFTH AVENUE- 10TH EL.
NEW YORK, NY 10151
EXAMINER
DECK, JASON A
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
02/13/2017 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):
prosecutiondocketing@flhlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARKUS KRUMME, ALBERT RADLMAIER,
SASCHA GENERAL, MICHAEL DITTGEN, and
KEITH JENSEN1
Appeal 2015-007452
Application 11/391,646
Technology Center 1600
Before ERIC B. GRIMES, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a system
for administering a steroid hormone, which have been rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as LTS Lohmann Therapie-
Systeme AG. (Appeal Br. 1.)
Appeal 2015-007452
Application 11/391,646
STATEMENT OF THE CASE
“[F]or various applications, an administration leading [to] a rapid rise
in the concentration of [a] steroid hormone in the blood would be desirable.”
(Spec. 1:13—16.) “Rapid release of active ingredients can be achieved by a
transmucosal administration. Dosage forms which disintegrate in an
aqueous environment, e.g. in the mouth, are known for this purpose.” {Id. at
1:24—27.)
Claims 1, 3—11, 13, 15, 16, 18, and 31—38 are on appeal. Claim 1 is
the only independent claim and reads as follows:
Claim 1. An administration system in film form for transmucosal
administration of a steroid hormone, comprising:
0.01-50% by weight of a steroid hormone which is selected from the
group consisting of an estrogen, a progesterone, an androgen, and a
mixture thereof;
50-99.99% by weight of a carrier material, selected from the group
consisting of cellulose, cellulose derivatives, poly-N-vinylpyrrolidones,
vinylpyrrolidone-vinyl acetate copolymers, starch, starch derivatives,
gelatin, gelatin derivatives and combinations thereof;
wherein the steroid hormone is dissolved in the carrier material; and
wherein the administration system:
has a weight per unit area of between 50 and 250 g/m2;
has a thickness of between 40 and 130 pm;
dissolves in the mouth completely in a period of less than 30
minutes; and
releases the steroid hormone contained therein on buccal
administration with a bioavailability of at least 50%.
2
Appeal 2015-007452
Application 11/391,646
The claims stand rejected as follows:
Claims 1, 3—11, 13, 16, and 31, 32, 37, and 38 under 35 U.S.C.
§ 103(a) based on Keith2 and Fuchs3 (Ans. 3);
Claims 18, 35, and 36 under 35 U.S.C. § 103(a) based on Keith,
Fuchs, and Chen4 (Ans. 7); and
Claims 15, 33, and 34 under 35 U.S.C. § 103(a) based on Keith,
Fuchs, and Dalton5 (Ans. 8—9).
DISCUSSION
The Examiner has rejected all of the claims on appeal as obvious
based on Keith and Fuchs, by themselves or combined with Chen or Dalton.
The same issue is dispositive for all of the rejections.
The Examiner finds that Keith teaches buccal dosage forms
comprising steroid hormones and polyethylene glycol, to which “high
molecular weight polymers such as polyvinylpyrrolidone are added to the
formulation to provide the matrix with water-activated adhesive properties
for good adhesion to the oral mucosa,” but does not teach that the carrier
material is 50—99.99% of the dosage form. (Ans. 3—4.)
The Examiner finds that Fuchs teaches a film dosage form comprising
a steroid hormone. {Id. at 4.) The Examiner finds that Fuchs teaches that
suitable “film-forming polymers including poly-N-vinyl-pyrrolidone,
copolymers of vinyl-pyrrolidone and vinyl acetate, methyl-cellulose, ethyl-
2 Keith et al., US 4,764,378, issued Aug. 16, 1988.
3 Fuchs et al., US 4,136,162, issued Jan. 12, 1979.
4 Chen et al., US 2003/0068378 Al, published Apr. 10, 2003.
5 Dalton et al. US 2004/0014975 Al, published Jan. 22, 2004.
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Appeal 2015-007452
Application 11/391,646
cellulose, etc.; preferably non-ionic, water-soluble, hydroxyalkyl ethers of
cellulose and especially hydroxypropyl-cellulose, hydroxyethyl-cellulose
and methylhydroxypropyl-cellulose.” (Id. at 4—5.) The Examiner also finds
that “Example 7 of Fuchs et al. teaches a dosage form comprising 0.86% of
ethinylestradiol and 65% of the carrier (cellulose and hydroxypropyl
cellulose).” (Id. at 5.)
The Examiner concludes that it would have been obvious
to have formulated the administration system comprising steroid
hormone with 50-99% of a carrier material because of the
teachings of Fuchs et al. The reference teaches formulations
comprising a steroid hormone and a natural carrier such as
cellulose and cellulose derivatives in the amount claimed in film
dosage forms for enteric administration. Hence one having
ordinary skill in the art at the time of the invention would have
formulated the administration system comprising a steroid
hormone with 50-99% natural carrier.
(Id. at 5—6.) With regard to the properties recited in the last “wherein”
clause of claim 1, the Examiner finds that Keith discloses the dissolution
time and bioavailability (id. at 4), and the thickness and weight per unit area
would have been reached through routine optimization (id. at 6—7).
Appellants argue that Keith describes its dosage form as being
composed of low molecular weight polyethylene glycol (PEG), medium or
high molecular weight PEG, and a high molecular weight polymer that can
be polyvinylpyrrolidone (PVP), but limits the amount of PVP to 1—40%, not
at least 50% as in claim 1. (Appeal Br. 11—12.) Appellants argue that “to go
from Keith’s maximum of 40% to Claim 1 ’s minimum of 50% would
require a 25% increase in the maximum amount disclosed by Keith.” (Id. at
12.)
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Appeal 2015-007452
Application 11/391,646
We agree with Appellants that Keith is directed to a specific
combination of low, medium, and high molecular weight polymers, of which
PVP is disclosed only as one possible high molecular weight polymer.
(Keith 2:19—31, 3:61 to 4:12.) Keith expressly limits the amount of high
molecular weight polymer in its dosage form to “about 1% to about 40% by
weight,” not 50% or more as required by claim 1. {Id. at 3:67.)
The Examiner reasons that the use of “about” indicates flexibility in
the range and that a skilled artisan would be led to optimize it in order to
adjust the properties of the matrix. (Ans. 12—13.) Routine optimization,
however, only applies to values that are within the general conditions
disclosed in the prior art. See In re Aller, 220 F.2d 454, 456 (CCPA 1955)
(“[Wjhere the general conditions of a claim are disclosed in the prior art, it is
not inventive to discover the optimum or workable ranges by routine
experimentation.”). The Examiner has not adequately shown that a skilled
worker would have recognized the amount of PVP required by claim 1 to be
within the “general conditions” of the 1—40% range disclosed by Keith.
The Examiner also states that “Fuchs et al. teaches that films
comprising active agents, such as steroids, be [sic] beneficially made via the
use of suitable film-forming polymers such as cellulose derivatives and
PVP.” (Ans. 11.) The Examiner states that “Fuchs et al. exemplifies
amounts of the film-forming polymers that are greater than 50%, such as in
Example 5 (the Examiner calculates that the final composition which
comprises 7.292 mg of hydroxypropyl cellulose (HPC) in a 7.5 mg
composition is 97% HPC by weight).” {Id. at 12.)
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Appeal 2015-007452
Application 11/391,646
To the extent that the Examiner is relying on Fuchs as teaching a
dosage form that meets or suggests all of the limitations of claim 1, however,
he has not cited evidence to show that Fuchs’ dosage form meets the
dissolution or bioavailability requirements of claim 1. Rather, the Examiner
relies on Keith’s dosage form to meet those requirements. (Ans. 4.) Thus,
the rejection is premised on modifying Keith’s dosage form to have the
amount of carrier required by claim 1, but, as discussed above, Keith
expressly limits the amount of high molecular weight polymer (e.g., PVP) in
its dosage form to no more than 40%.
In sum, the Examiner has not shown that the system of claim 1 would
have been obvious based on Keith and Fuchs. The Examiner cites Chen and
Dalton to meet limitations of dependent claims (Ans. 8—9), but does not
point to any disclosure in either reference that makes up for the deficiency
discussed above. We therefore reverse all of the rejections on appeal.
REVERSED
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