Ex Parte Steiner et al

Patent Trial and Appeal Board

Oct 26, 2016

12891240 (P.T.A.B. Oct. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/891,240 09/27/2010
23579 7590 10/26/2016
Pabst Patent Group LLP
1545 PEACHTREE STREET NE
SUITE 320
ATLANTA, GA 30309
FIRST NAMED INVENTOR
Solomon S. Steiner
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
SOLO 119 CIP 9988
EXAMINER
HELLMAN, KRISTINA M
ART UNIT PAPER NUMBER
1675
MAILDATE DELIVERY MODE
10/26/2016 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 SOLOMONS. STEINER, ROBERT HAUSER, MING LI,
ROBERT FELDSTEIN, and RODERIKE POHL1
Appeal2014-005492
Application 12/891,240
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and RACHEL H.
TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
stabilized glucagon formulation, which have been rejected for obviousness
and, provisionally, for obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse the obviousness rejections
but affirm the double patenting rejections.
1 Appellants identify the Real Party in Interest as Biodel, Inc. (Appeal Br.
2.)
Appeal2014-005492
Application 12/891,240
STATEMENT OF THE CASE
"[G]lucagon increases the concentration of glucose in the blood."
(Spec. 1:19-20.) Glucagon is soluble in aqueous solution at low or high
pHs, but "has low solubility in the pH range of 4 to 8 .... It forms a gel in
acidic aqueous conditions (pH 3-4) and precipitates within an hour of
preparation in a neutral aqueous solution." (Id. at 1:28-31.)
The Specification reports that the commercial preparation of glucagon
is a two-part vial, to be reconstituted immediately before use. (Id. at 2: 1-2.)
An "artificial pancreas" for treatment of diabetes needs to be capable of
keeping a patient within ideal glucose levels, providing insulin or glucagon
as needed. (Id. at 2:31-3: 11.) Thus, an artificial pancreas "requires a
glucagon that is stable in solution for at least seven days at 30-37°C." (Id. at
3: 13-14.)
Claims 1---6 and 8-23 are on appeal. Claim 1 is the only independent
claim and reads as follows:
1. A stabilized glucagon formulation comprising
Glucagon,
a surfactant, and
a monosaccharide,
wherein the surfactant and monosaccharide are in an effective amount
to enhance the stability of glucagon, as compared to the stability of glucagon
in combination with the surfactant, and
wherein the osmolarity is approximately 200 to 400 mOsm and the pH
is between 2 and 8.
2
Appeal2014-005492
Application 12/891,240
The claims stand rejected as follows:
Claims 1---6, 8-11, and 14--23 under 35 U.S.C. § 103(a) based on
Kaarsholm2 and Pedersen3 (Ans. 3);
Claims 12 and 13 under 35 U.S.C. § 103(a) based on Kaarsholm,
Pedersen, and Weldele4 (Ans. 6);
Claims 1---6, 8-11, and 14--23, provisionally, for obviousness-type
double patenting based on claims 1-17 of application 12/715,203 (Ans. 16);
and
Claims 12 and 13, provisionally, for obviousness-type double
patenting based on claims 1-17 of the '203 application in view of Weldele
(Ans. 16).
I
The Examiner has rejected all of the claims on appeal as obvious
based on Kaarsholm and Pedersen, either by themselves or further combined
with Weldele. The same issue is dispositive for both rejections.
The Examiner finds that Kaarsholm discloses stabilized compositions
of a peptide that can be glucagon comprising a detergent and an isotonic
agent, but where the isotonic agent is mannitol rather than a monosaccharide
as required by the claims. (Ans. 3--4.) The Examiner finds that Pedersen
discloses a variety of tonicity agents, including mannitol and glucose, and
their use in glucagon-containing pharmaceutical formulations. (Id. at 4.)
2 US 6,384,016 Bl, issued May 7, 2002.
3 US 2007/0010424 Al, published January 11, 2007.
4 US 2006/0293382 Al, published December 28, 2006.
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Appeal2014-005492
Application 12/891,240
The Examiner also finds that Pedersen discloses solutions having
osmolarities within the range recited in claim 1. (Id.)
The Examiner finds that development of stabilized glucagon solutions
was a recognized problem in the art, and Pedersen teaches that use of
mannitol in peptide formulations improves their stability, but the mannitol
crystallizes and clogs injection devices. (Id.) The Examiner concludes that
it would have been obvious "to substitute the isotonicity agents taught by
Pedersen et al. for the mannitol in the compositions taught by Kaarsholm
and to screen for stable formulations. The optimization and screening would
likely result in the selection of glucose." (Id. at 5.)
Appellants argue, among other things, that Pedersen teaches away
from including glucose in a glucagon-containing formulation because
"Pederson expressly states that because glucose is a reducing saccharide, it
is able to initiate unwanted degradation in the formulation, and thus is ruled
out as a suitable tonicity modifier. See Pederson [sic], para. [0192]
(emphasis added)." (Appeal Br. 16-17.) Appellants argue that "[o]ne o[fJ
ordinary skill in the art in selecting an agent to enhance the stability of
glucagon, would consider Pederson's [sic] disclosure highly relevant, and
would be led to select a different agent to replace mannitol." (Id. at 18.)
The Examiner discounts the foregoing because "the previous
statement within the same paragraph [states] that glucose is a 'suitable
replacement' candidate for mannitol" and concludes that "glucose is one of a
finite number of tonicity modifying agents that would be obvious to test."
(Ans. 14.) However, we agree with Appellants that, when Pedersen is
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Appeal2014-005492
Application 12/891,240
considered as a whole, it would not have led a skilled worker to modify
Kaarsholm's composition to include glucose.
The critical paragraph in Pedersen reads as follows (emphasis added):
In the simulated filling experiment xylitol, glycerol, glucose,
maltose, PEG 400, propylene glycol, sorbitol, sucrose and
glycine were found to be suitable replacements candidates for
mannitol. However, as glucose is a reducing saccharide, and
therefore is able to initiate unwanted degradation in the
formulation, this tonicity modifier is ruled out. Furthermore,
maltose is ruled out due to clogging of needles. This leads to the
following candidates: glycerol, xylitol, sorbitol, sucrose, glycine,
propylene glycol and PEG 400, which are found to have suitable
properties as replacement[] candidates for mannitol in peptide
formulations with regards to drop test, clogging of needles and
simulated filling.
(Pedersen i-f 192.)
Thus, Pedersen discloses that, with respect to its effect on a peptide
formulation in a simulated filling experiment using a placebo formulation of
preservative, buffer, isotonic agent, and pH adjuster (Pedersen i-fi-1 180, 181,
190), glucose is a suitable replacement for mannitol because it does not form
deposits and clog injection devices. (Cf id. i-f 3.) However, Pedersen
immediately cautions that, because glucose can cause unwanted degradation
in peptide formulations, it is "ruled out" as an acceptable tonicity modifier
for use in place of mannitol. In the critical paragraph, Pedersen lists the
specific tonicity modifiers that have "suitable properties as replacement[]
candidates for mannitol in peptide formulations" and the list does not
include glucose. Considered as a whole, then, Pedersen would be
understood to state that glucose does not have suitable properties as a
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Appeal2014-005492
Application 12/891,240
replacement for mannitol as a tonicity modifier, because it can cause
unwanted degradation in peptide formulations.
In summary, we agree with Appellants that Kaarsholm and Pedersen,
when considered as a whole, would not have led a person of ordinary skill in
the art to replace the mannitol in Kaarsholm's formulation with glucose.
The rejection of claims 1---6, 8-11, and 14--23 under 35 U.S.C. § 103(a)
based on Kaarsholm and Pedersen is reversed.
The rejection of claims 12 and 13 depends on the same combination
of Kaarsholm and Pedersen; Weldele is cited only as a basis for adding
ethanol to the composition. (Ans. 6-7.) Thus, the rejection of claims 12 and
13 suffers from the same deficiency discussed above, and is reversed for the
same reason.
II
In addition to the rejections under§ 103(a), the claims have also been
provisionally rejected for obviousness-type double patenting based on
application 12/715,203. (Ans. 16.) Claim 1 of the '203 application reads as
follows:
1. A stabilized glucagon formulation comprising
between 0.8 and 1.5 mg/mL of glucagon,
between 0.5 and 5 mg/mL of lyso myristoyl phosphocholine
(LMPC),
between 20 and 100 mg of a monosaccharide or
disaccharide/ml,
and
between 0.2 and 3 mg/mL of a preservative,
having enhanced stability of the glucagon in an aqueous
solution at physiological temperature as compared to glucagon not
formulated with LMPC or the monosaccharide or disaccharide.
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Application 12/891,240
Claim 1 of the instant application and claim 1 of the '203 application
thus are both directed to a stabilized glucagon formulation comprising
glucagon, a surfactant (LMPC specifically in the '203 application), and a
monosaccharide (or disaccharide in the '203 application). We agree with the
Examiner that these claims are directed to products that are not patentably
distinct.
With regard to claims 12 and 13 on appeal, which additionally require
ethanol in the claimed formulation, the Examiner finds that Weldele
discloses that ethanol stabilizes warfarin in solution, and concludes that it
would have been obvious to include ethanol in a glucagon-containing
formulation for the same effect. (Ans. 7.) We agree, and we agree with the
Examiner's conclusion that claims 12 and 13 are obvious variants of claim 1
of the '203 application, in view of Weldele.
Appellants state that "since the scope of the cited claims could change
during prosecution, Appellants do not address these rejections in this Appeal
Brief. However, Appellants will address the rejections when the current
claims are otherwise found allowable." (Appeal Br. 6.)
As provided in the MPEP, however,
[i]f"provisional" ODP rejections in two applications are the only
rejections remaining in those applications, the examiner should
withdraw the ODP rejection in the earlier filed application
thereby permitting that application to issue without need of a
terminal disclaimer. A terminal disclaimer must be required in
the later-filed application before the ODP rejection can be
withdrawn and the application permitted to issue.
MPEP § 804(I)(B)(l)
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Application 12/891,240
Here, the present application is the later-filed of the two applications
and therefore, "[a] terminal disclaimer must be required ... before the ODP
rejection can be withdrawn and the application permitted to issue." Id.
SUMMARY
We reverse both the rejections under 35 U.S.C. § 103(a).
We affirm both of the provisional rejections for obviousness-type
double patenting.
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
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