Ex Parte Trill et al

Patent Trial and Appeal Board

Nov 13, 2018

13498617 (P.T.A.B. Nov. 13, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/498,617 03/28/2012
23347 7590 11/15/2018
GLAXOSMITHKLINE
Global Patents UP4110
1250 South Collegeville Road
Collegeville, PA 19426
FIRST NAMED INVENTOR
Helen Mary Trill
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.
PB63742US 1248
EXAMINER
LOUIS,LATOYAM
ART UNIT PAPER NUMBER
3785
NOTIFICATION DATE DELIVERY MODE
11/15/2018 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):
laura.m.mccullen@gsk.com
US_cipkop@gsk.com
eofficeaction@appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HELEN MARY TRILL and WILLIAM FREDRICK
Appeal2018-001633
Application 13/498,617
Technology Center 3700
Before PHILIP J. HOFFMANN, KENNETH G. SCHOPPER, and
BRADLEY B. BAY AT, Administrative Patent Judges.
HOFFMANN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeal from the
Examiner's rejection of claims 25-28, 34--39, 41--47, 50, 53, and 56-61.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
According to Appellants, the invention "relates to a pressuri[z]ed
metered dose inhaler (pMDI) and, in particular, componentry therefor."
1 According to Appellants, the real party in interest is "Glaxo Group
Limited d/b/a GlaxoSmithKline." Appeal Br. 4.
Appeal2018-001633
Application 13/498,617
Spec. 1. Claims 25-27 are the independent claims on appeal. Below, we
reproduce claim 25 as illustrative of the appealed claims.
25. A pressurized metered dose inhaler (pMDI)
metering valve comprising at least one component which
comprises a desiccant-entrained material which is a mixture
comprising a base polymer, a desiccant and a channeling agent
that facilitates transmission of water into the material, wherein
the channeling agent comprises polyethylene glycol with an
average molecular weight which is at least 16000 daltons.
REJECTIONS AND PRIOR ART
The Examiner rejects the claims as follows:
I. claims 25-28, 34--37, 39, 41, 43, 45, 46, 50, 53, 56-59, and 61
under 35 U.S.C. § I03(a) as unpatentable over Cripps et al.
(US 2003/0180228 Al, pub. Sept. 25, 2003) ("Cripps), Hekal
(US 6,214,255 Bl, iss. Apr. 10, 2001), and Rowe et al.
(US 6,939,557 B2, iss. Sept. 6, 2005) ("Rowe");
II. claims 38 and 42 under 35 U.S.C. § I03(a) as unpatentable over
Cripps, Hekal, Rowe, and Kay (US 8,353,706 B2, iss. Jan. 15,
2013); and
III. claims 44, 47, and 60 under 35 U.S.C. § I03(a) as unpatentable
over Cripps, Hekal, Rowe, and Millar (US 7,566,445 B 1, iss.
July 28, 2009).
ANALYSIS
Rejection I
Based on our review of the record, including the Examiner's Final
Office Action and Answer, and Appellants' Appeal Brief and Reply Brief,
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Application 13/498,617
Appellants do not persuade us that the Examiner errs in rejecting claims 25-
28, 34--37, 39, 41, 43, 45, 46, 50, 53, 56-59, and 61 as obvious based on
Cripps, Hekal, and Rowe. Thus, we sustain the rejection.
Appellants argue that the rejection is in error because
there is no clear articulated reason to support an obviousness
rejection. All that the Office has done in citing Cripps is to
allegedly draw attention to a pMDI system that may utilize a
component made from a desiccant entrained material which is a
mixture of a desiccant and a channeling agent of PEG. No reason
or rationale has been set forth as to why one would even want to
modify Cripps. . . . Closely examining Hekal clearly indicates
that it is directed to desiccant entrained polymers including
means by which desiccant located within interior portions of the
polymer structure are exposed to moisture that is exterior to the
polymer body. . . . Nothing would suggest using [Hekal's]
materials in [Cripps's] pMDI as claimed.
Appeal Br. 8.
In the obviousness rejection (Final Action 3), the Examiner cites
Cripps's paragraph 69, which discloses "[t]he moisture absorbing means will
generally comprise a desiccant material" (Cripps ,r 69). In addition, the
Examiner cites (Final Action 6) paragraph 87 of Cripps, which discloses
"[i]n conjunction with the desiccant[,] an additional compound may be
added to act as a conduit/channeling agent to increase/optimi[z]e the
efficiency of the moisture absorption. Such materials may include
compounds such as polyethylene glycols" (Cripps ,r 87). Although the
Examiner finds that Hekal, rather than Cripps, discloses the claimed
desiccant-entrained material (Final Action 3), the Examiner determines that
"[i]t would have been obvious ... to manufacture the desiccant entrained
material of Cripps to include the desiccant, channeling agent, and base
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Application 13/498,617
polymer as a mixture as taught by Hekal to provide enhanced moisture
absorption and moisture reduced environments" (id.; see Answer 3, 9).
We are not persuaded of error because the Examiner's reason for
replacing Hekal' s material with Cripps' s material is supported adequately by
Hekal. For example, Hekal discloses that the material provides advantages
"such as rigidity and durability," and "normally acts as a moisture barrier in
a solidified state ... so that the channeling agent forms passages in the
mixture through which moisture is communicable to [a] desiccating agent
that is entrained within the mixture." Hekal, Abstract. Hekal further
discloses that "[t ]he desiccant[-]entrained polymer of the present invention is
particularly useful in the manufacture of containers and packaging for items
requiring moisture reduced environments." Hekal col. 1, 11. 19-22. By way
of additional example, Hekal discloses that "it is a well[-]known practice to
include a desiccating unit together with ... medication in the container."
See Hekal col. 1, 11. 39--46; see also Hekal col. 5, 11. 25-31 ("The present
invention[] has been developed in response to a recognized need for
structures constructed from polymers that normally act as moisture barriers
in their solid, rigid state, but when produced according to the present
invention have a desiccant entrained therein which is capable of absorbing
moisture exterior to the polymer."). Thus, based on the foregoing, we
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disagree with Appellants that "[n]othing would suggest using [Hekal's]
materials in [Cripps's] pMDI as claimed."2 Appeal Br. 8.
Appellants argue that the Examiner errs because "Rowe teaches away
from the" Examiner's proposed combination of Rowe with Hekal and
Cripps. Appeal Br. 11; see also id. at 9-11. More specifically, according to
Appellants,
the [Examiner] has not taken into account all of Rowe's
teachings when combining it with the other references. Rowe is
directed to biodegradable compositions for sustained-release
drug delivery[,] and methods for administering a biologically
active substance ("BAS") via these compositions . . . . Such
BASs are acknowledged by Rowe to be difficult to formulate in
biodegradable polymers to allow a desired release into the
patient's system. In furtherance of this end, Rowe teaches a
biocompatible therapeutic article for delivery of a BAS, in which
the article comprises a macromer, a molecule[,] or [a] mixture of
molecules which preferentially excludes proteins and the BAS.
The macromer[] comprises a region forming a central core, and
least two decradable regions attached to the core and at least two
polymerizable end groups .... The region forming a central core
is taught to be a water soluble region that may include
poly( ethylene glycol) . . . . Accordingly, one skilled in the art
would understand that the PEG is to dissolve over time.
However, this is the complete antithesis of the requirements of
the claimed invention, where leaching of PEG into the inhalable
drug formulation is to be strictly avoided, due to the impact it
would have on dose consistency, termed "PPM" in [Appellants']
[S ]pecification.
2 We note that the Summary of the Invention section of Appellants'
Specification indicates that their desiccant-entrained material may be the
"material ... disclosed in" U.S. Patent no. 5,911,937 ("the '937 patent"),
issued June 15, 1999, to Hekal et al., which is "incorporated [t]herein by
reference." Spec. 6. Each of the '937 patent and Hekal is a continuation-in-
part of U.S. Application no. 08/424,996, filed April 19, 1995.
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Appeal Br. 9-10 ( citations omitted). We disagree with Appellants, however.
"A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant." In re Kahn, 441 F.3d 977, 990
(Fed. Cir. 2006) ( citations and internal quotation marks omitted). See also
In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (noting that merely
disclosing more than one alternative does not teach away from any of these
alternatives if the disclosure does not criticize, discredit, or otherwise
discourage the alternatives). In this case, Appellants' argument does not
persuade us that one of ordinary skill, when reading the references, would be
discouraged from combining the references as the Examiner proposes. For
example, Appellants do not present any evidence tending to establish that
"leaching of PEG into the inhalable drug formulation" would occur to the
extent that "it would [impact] dose consistency," as Appellants argue.
Appeal Br. 10.
Appellants argue that the Examiner errs because it is only based on
impermissible hindsight that the Examiner combines Rowe with Hekal and
Cripps. See id. at 10-11. We disagree with Appellants. Instead, despite
differences among the references, we agree with the Examiner that "[ o ]ne of
ordinary skill ... upon seeing the PEG of Cripps would recognize that the
molecular weight of greater than 16,000 Daltons as taught by Rowe would
provide the advantage of adequate channeling effect. Thus[,] Rowe is
relevant." Answer 10. Appellants' remarks are insufficient to persuade us
otherwise.
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Therefore, based on the foregoing, we sustain the Examiner's
obviousness rejection of claims 25-28, 34--37, 39, 41, 43, 45, 46, 50, 53, 56-
59, and 61.
Rejections II and III
Appellants do not argue against the Examiner's obviousness rejections
of dependent claims 38, 42, 44, 47, and 60. Thus, inasmuch as we sustain
the rejection of the independent claims from which claims 38, 42, 44, 47,
and 60 depend, we also sustain the dependent claims' rejections.
DECISION
We AFFIRM the Examiner's obviousness rejections of claims 25-28,
34--39, 41--47, 50, 53, and 56-61.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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