Ex Parte Boss et al

Patent Trial and Appeal Board

Aug 17, 2016

13357821 (P.T.A.B. Aug. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/357,821 01125/2012 Anders Hasager Boss
45200 7590 08/19/2016
K&L Gates LLP-Orange County
1 Park Plaza
Twelfth Floor
IRVINE, CA 92614
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.
1951300.00089 DIV 3450
EXAMINER
CHANDRA,GYAN
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
08/19/2016 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDERS HASAGER BOSS, RICHARD PETRUCCI,
CAMPBELL HOW ARD, and ALFRED MANN
Appeal 2014-007218
Application 13/357,821 1
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and RY ANH. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to methods of controlling glycemia. Claims 19--24 and 26-
37 are on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
1 The Real Party in Interest is Mannkind Corporation. App. Br. 3.
Appeal2014-007218
Application 13/357,821
STATEMENT OF THE CASE
The Specification describes treating diabetes mellitus using an
ultrarapid acting insulin formulation. Spec. i-f 21. The disclosed methods
include determining dosages, using standard dosages that are not adjusted
meal-to-meal, and using split dosages where the standard insulin dosage is
administered at the beginning of the meal and a second dosage is
administered at a subsequent point in time. Id., see also i-f 46.
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 19, 21, and 26 are independent claims. Claim 26 is
representative reads as follows:
26. A method of controlling glycemia related to one or more
daily meals in an individual with diabetes by administering a
total insulin dosage comprising an initial predetermined dose,
comprising the steps of:
administering an initial predetermined dose of an ultrarapid
acting insulin formulation at mealtime for the daily meal,
wherein the initial predetermined dose is a standard dose for the
daily meal; and,
administering a supplemental dose of the ultrarapid acting
insulin formulation 30 to 120 minutes after beginning the meal.
App. Br. 18 (Claims App'x).
The following rejections are on appeal:
Claims 19--24, 26, 27 and 30 rejected under 35 U.S.C. § 103(a) as
unpatentable over Boss2 and Singley. 3 Final Action 2.
2 U.S. Patent Application Pub. No. US 2007 /0027063 Al (published Feb. 1,
2007) (hereinafter "Boss").
3 U.S. Patent Application Pub. No. US 2005/0187749 Al (published Aug.
25, 2005) (hereinafter "Singley").
2
Appeal2014-007218
Application 13/357,821
Claims 28, 29, and 31-37 rejected under 35 U.S.C. § 103(a) as
unpatentable over Boss, Singley, and Camilleri. 4 Final Action 6.
DISCUSSION
We address both obviousness rejections together because Appellants
present the same arguments for the reversal of each. The Examiner
determined the claims were obvious over the combined prior art references,
in part, because the Boss reference (i-fi-f l 03--4) disclosed treating a patient
with insulin (ultrarapid acting, standardized dose) at mealtime and then
measuring blood glucose sixty minutes after eating; concluding thereby, that
it would have been obvious to give such a patient a supplemental dose of
insulin after the meal. Final Action 4.
Among other contentions, Appellants argue that Boss "does not teach
or suggest taking any action in response to those [post-meal] BG
measurements, and it certainly does not teach or suggest the administration
of a supplemental dose in response to a measurement within any specific
time range." Reply Br. 10. Appellants' argument is persuasive. The focus
of the Boss disclosure is on administering insulin to mimic the body's
natural "meal-related early phase insulin response, using a dose sufficient to
reduce serum levels of proinsulin and/or control glucose excursions." Boss
i124. Boss states that "insulin is administered to a patient in need of insulin
therapy at mealtime, that is, within about 10 minutes, preferably 5 minutes
4 Michael Camilleri, Diabetic Gastroperesis, 356 NEW ENGLAND J. MED.
820-29 (2007) (hereinafter "Camilleri").
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Appeal2014-007218
Application 13/357,821
before, or 30, 25, 15, or 10 minutes after starting a meal." Id. Thus, Boss
discloses administering a single dose of insulin around the time of a meal.
Boss's Example 3, cited by the Examiner, is directed to determining
the effective single meal-time dose of insulin for this treatment, which it
concludes would be the 24 IU and 48 IU doses tested. Boss i-fi-1103-4. There
is no teaching or suggestion in Boss to supplement these initial insulin doses
at a time post-meal. Thus, Boss discloses measuring blood glucose after a
meal in order to determine what insulin dose should be given with the meal,
not in conjunction with a supplemental dose of insulin. None of the other
references is determined by the Examiner to remedy this shortcoming of
Boss in view of the claimed subject matter.
For the above reasons, we find that the evidence of record supports
Appellants' contention that the claims are not obvious over the cited prior art
combination.
SUMMARY
The rejection of claims 19-24, 26, 27 and 30 under 35 U.S.C. § 103(a)
over Boss and Singley is reversed.
The rejection of claims 28, 29, and 31-37 under 35 U.S.C. § 103(a)
over Boss, Singley, and Camilleri is reversed.
REVERSED
4