Ex Parte Smith

Patent Trial and Appeal Board

Nov 14, 2016

13380083 (P.T.A.B. Nov. 14, 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.
13/380,083 12/22/2011 Ian Smith MPB 3007-US 6488
124076 7590 11/16/2016
Mylan Pharmaceuticals Inc.
5005 Greenbag Road
Morgantown, WV 26501
EXAMINER
LYDDANE, KATHRYNN M
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
11/16/2016 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IAN SMITH
Appeal 2014-009992
Application 13/380,083
Technology Center 3700
Before JILL D. HILL, LISA M. GUIJT, and ERIC C. JESCHKE
Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Ian Smith (“Appellant”) appeals under 35 U.S.C. § 134(a) from the
Examiner’s decision to reject claims 1 and 4—21.1 We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
1 Claims 2 and 3 are cancelled. Appeal Br. 18 (Claims App.).
Appeal 2014-009992
Application 13/380,083
CLAIMED SUBJECT MATTER
Sole independent claim 1, reproduced below, represents the claimed
subject matter, with the key disputed limitation italicized.
1. A dose unit for a dry powder inhaler comprising:
a dose carrier (15; 515, 524) including a plurality of
pockets (17; 517) each adapted to contain a dose of medication
powder suitable for inhalation, said pockets being sequentially
arranged such that the content of the pockets (17; 517) can be
sequentially exposed to a flow of air (Fa) for successive
inhalations and
a plurality of medication powder doses (X; XI, X2)
arranged in said pockets (17; 517) of the dose carrier (15),
wherein the doses are regularly distributed in the pockets
according to a sequence of identical groups, each group
including at least one blank pocket (B) containing an excipient
powder without pharmaceutically active ingredient and one
pocket containing a dose of medication powder (X; XI, X2).
REJECTIONS2
I. Claims 1 and 6—21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Anderson (US 2005/0154491 Al; pub. July 14, 2005),
Nilsson (US 2006/0120969 Al; pub. June 8, 2006), and Genosar (US
2010/0139655 Al; pub. June 10, 2010).
II. Claims 4 and 5 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Anderson, Genosar, Nilsson, and Houzego (WO
2005/002564 Al; pub. Jan. 13, 2005).
2 The Examiner rejected claim 5 under 35 U.S.C. § 112, second paragraph.
Final Act. 2. In the Advisory Action, the Examiner withdraws this rejection.
Adv. Act. 1.
2
Appeal 2014-009992
Application 13/380,083
ANALYSIS
Rejection I
Regarding claim 1, the Examiner finds that Anderson discloses the
limitations thereof, but does not disclose that each group of its “sequence of
identical groups” includes at least one blank pocket containing an excipient
powder without a pharmaceutically active ingredient. Final Act 3^4. The
Examiner finds, however, that Genosar discloses an inhaler with a magazine
of drug containing volumes that may comprise a different drug or drug
combination. Id. at 4. According to the Examiner, one of the drugs of
Genosar could be an excipient, because the term “drug” is defined as “a
substance used as a medication or in the preparation of a medication,” which
includes excipients. Id.
The technical dictionary definitions of “drug” and “excipient”
provided by Appellant are more consistent with the usage of these terms in
Genosar. See Appeal Br. 4 (citing Gerhard Nahler, Dictionary of
Pharmaceutical Medicine, 2d Edition, p. 56 (2009)). In addition, Genosar
expressly defines the term “drug” as a pharmaceutically active ingredient,
which is necessarily present in its pockets with or without added excipient.
Appeal Br. 11. Appellant explains that an excipient can be a vehicle for a
drug, but that the term excipient is understood by those skilled in the art to
be excluded from the term “drug.” Id. at 12. Regarding the meaning of the
term “drug,” Appellant has the better argument. The general dictionary
relied upon by the Examiner (Ans. 5) is not consistent with the technical
dictionary or the use of the term “drug” in Genosar, which distinguishes
drugs, vaccines, and therapeutic agents from excipients.
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Appeal 2014-009992
Application 13/380,083
Given the above reasonable definition of the term “drug,” Appellant
contends that Genosar does not disclose that its magazine contains an
excipient powder without pharmaceutically active ingredient because each
of the magazines includes a drug, vaccine, or therapeutic agent. Appeal Br.
11 (citing Genosar 117). We agree with Appellant.
The Examiner then finds that “[f]urther evidence of the use of
excipient and blank medication volumes is taught by Nilsson,” which
discloses an inhaler with insulin dose containers representing empty, low,
medium, and high doses, “so that the size of the insulin dose is selected by a
user before each administration.” Final Act. 4 (citing Nilsson 136). The
Examiner concludes that it would have been obvious that Nilsson’s “empty
dose container” is “empty of active insulin, but could contain excipient
powder” that acts as a carrier for the GLP-1. Id. at 5 (emphasis added).
Appellant argues that Nilsson discloses administering GLP-1 with
insulin or with an empty dose container, and that there is no disclosure of the
empty dose containers containing an excipient powder. Appeal Br. 12, 13
(citing Nilsson || 36, 61, 63).
In response, the Examiner agrees that Nilsson provides “no explicit
teaching of ‘individually sealed enclosures containing only excipient.’”
Ans. 7. The Examiner contends again, however, that when only one of
Nilsson’s drugs is administered, the empty pocket could include an inert
substance, such as an excipient. Id. at 7—8.
Appellant has the better argument. Nilsson fails to explicitly disclose
that the empty dose container may contain excipients, as acknowledged by
the Examiner. See Ans. 7. Indeed, the dose container is referred to as
“empty,” which indicates that it contains nothing. See Nilsson 136. The
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Appeal 2014-009992
Application 13/380,083
Examiner speculates that the empty pocket could contain excipient, but
obviousness cannot be established using factual findings that are based on
speculation.
For these reasons, we do not sustain the rejection of claim 1. Claims
6—21 depend directly or indirectly from claim 1, and we therefore do not
sustain the rejection thereof.
Rejection II
Rejection II additionally pertains to claims that depend from
independent claim 1. The Examiner does not rely on Houzego in any
manner that would cure the deficiencies of Anderson, Genosar, and Nilsson,
and we, therefore, do not sustain Rejection II for the reasons set forth above
regarding Rejection I.
DECISION
We REVERSE the Examiner’s rejection of claims 1 and 6—21 under
35 U.S.C. § 103(a) as unpatentable over Anderson, Nilsson, and Genosar.
We REVERSE the Examiner’s rejection of claims 4 and 5 under
35 U.S.C. § 103(a) as unpatentable over Anderson, Genosar, Nilsson, and
Houzego.
REVERSED
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