Ex Parte Wachtel et al

Patent Trial and Appeal Board

Aug 16, 2017

13145670 (P.T.A.B. Aug. 16, 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.
13/145,670 10/24/2011 Herbert Wachtel 02-0329-US-l 7134
28502 7590
C/O VP, IP, LEGAL
BOEHRINGERINGELHEIM USA CORPORATION
900 RIDGEBURY ROAD
P. O. BOX 368
RIDGEFIELD, CT 06877-0368
EXAMINER
STANIS, TIMOTHY A
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
08/18/2017 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):
US PTO.e-Office. rdg@ boehringer-ingelheim .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HERBERT WACHTEL, ANDREE JUNG,
JENS BESSELER, and MANUEL KRAKOWKA
Appeal 2015-006355
Application 13/145,67c1
Technology Center 3700
Before MICHAEL L. HOELTER, NATHAN A. ENGELS, and
BRENT M. DOUGAL, Administrative Patent Judges.
ENGELS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from a final rejection of
claims 1—13. No other claims are pending. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.
1 Appellants identify Boehringer Ingelheim International GmbH as the real
party in interest.
Appeal 2015-006355
Application 13/145,670
ILLUSTRATIVE CLAIM
Claim 1, reproduced below, is the only independent claim at issue and
is illustrative of the claimed subject matter:
1. An inhaler for delivery of an inhalation formulation from a
band-shaped blister strip having a plurality of receptacles
containing the inhalation formulation in doses, the inhaler
comprising:
a conveyor for stepwise advancement of the blister strip,
and
a piercing member operating to puncture respective lids of
the receptacles, the piercing member comprising only first and
second piercing elements for forming only respective first and
second openings in the lids, the first opening communicating
with an air inlet and the second opening communicating with an
air outlet, the piercing member being formed from sheet metal
and the first and second piercing elements being formed by
bending respective portions thereof into inclined positions such
that the piercing elements extend in a V-shape away from each
other,
wherein the piercing member includes a planar base
overlying the air inlet and the air outlet, each of the first and
second piercing elements includes a proximal end starting at the
planar base, and each of the first and second piercing elements
extends entirely in a respective, single plane away from the
planar base to a distal end of the respective first and second
piercing elements,
wherein the inhaler is designed such that an air stream of
ambient air is delivered to the first opening via the air inlet in
response to an inhale action by a user, and the air stream carries
the respective dose from the receptacle through the second
opening and to the user.
THE REJECTION
Claims 1—13 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable in view of Eason et al. (US 2007/0137645 Al; June 21, 2007),
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Application 13/145,670
Harmer et al. (WO 2006/108877 A2; Apr. 15, 2005) (“Harmer ’877”),
Harmer et al. (US 2007/007472 Al; Apr. 5, 2007) (“Harmer ’472”), and
Smith et al. (US 6,089,228; July 18, 2000).
ANALYSIS
In relevant part, the Examiner’s rejection of independent claim 1 cites
Eason for disclosures of an inhaler for delivery of an inhalation formulation
from a band-shaped blister strip, including a piercing member operating to
puncture lids of receptacles of the blister strip. Final Act. 3 (citing Eason
Figs. 1, 7, 9, 13, 18). The Examiner finds Eason’s piercing member
comprises only first and second piercing elements, with each of the first and
second piercing elements extending in a respective plane away from a planar
base to a distal end of the respective first and second piercing elements.
Final Act. 3^4 (citing Eason Figs. 9, 18). The Examiner also states that
Eason “does not disclose that the piercing elements extend in a V-shape
away from each other,” but the Examiner finds Harmer ’877 discloses two
blister piercing elements that extend in a V-shape away from each other.
Final Act. 4 (citing Harmer ’877 Figs. 9, 18, 19, 20).
In response to the Examiner’s rejection of claim 1 based on the
combination of Eason, Harmer ’877, and Harmer ’721, Appellants
“amended the claims to recite that the piercing elements extend from the
base entirely in a single plane.” Appeal Br. 6. Appellants state that “[i]n
response to the amendment, in the Final Office Action of October 8, 2014,
the Examiner added a new secondary reference, Smith (US 6,089,228), to
the obviousness rejection.” Appeal Br. 6. According to the Examiner,
Smith teaches first and second piercing elements that form a V-shape and
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Application 13/145,670
extend entirely within respective single planes away from a planar base.
Final Act. 6 (citing Smith Figs. 16, 19).
On Appeal, Appellants argue that the Examiner’s combination of
references is improper. Specifically, Appellants argue Harmer ’877
“requires that the blades have a first portion 71 that extends generally
straight up, and a second portion 72 that extends at the transverse angle in
order to address the effect of a flap 73 in the seal resulting from the piercing
action.” Appeal Br. 8. According to Appellants, Harmer ’877 describes its
blade configuration as critical and “criticizes merely puncturing the seal and
preventing blockage of the holes — indeed, the reference sets out an essential
function of thoroughly evacuating the powders and ensuring that the flow
path between the inlet and outlet is open and that no ‘dead areas ’ exist
where powder can become trapped.” Appeal Br. 8—9 (citing Harmer ’877 p.
22,11. 23—28). Further, Appellants contend “[t]he design features that the
blades have a first portion 71 that extends generally straight up, and a second
portion 72 that extends at the transverse angle therefore become essential
and the motivation to employ them become inescapable to the skilled
artisan.” Appeal Br. 9. Moreover, Appellants argue “[t]he Examiner’s
proposed modification to make the piercing elements extend entirely in a
respective, single plane would destroy the very structure [of Harmer ’877]
that a skilled artisan would be motivated to employ.” Appeal Br. 9.
In addition, Appellants argue the piercing elements of Smith would
create two flaps and two resultant inlets, as well as an additional central
outlet. Appeal Br. 9. According to Appellants, “[t]his is a very different
result than the desired aerodynamics of Eason” and would further
complicate the motivations of a skilled artisan. Appeal Br. 9.
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Application 13/145,670
We disagree with Appellants’ arguments. The Supreme Court has
explained that “when a patent ‘simply arranges old elements with each
performing the same function it had been known to perform’ and yields no
more than one would expect from such an arrangement, the combination is
obvious.” KSRInt’l Co. v. Teleflex Inc., 550 US 398, 417 (2007) (quoting
Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). Further, “[t]he test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference; . . . the test is
what the combined teachings of the references would have suggested to
those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA
1981).
Appellants’ arguments addressing the individual differences between
the piecing elements of Harmer ’877 and Smith attack the references
individually and assume bodily incorporation of those elements without
rebutting the substance of the Examiner’s rejection. See id. The Examiner
cites Harmer ’877 and Smith as disclosures of piecing elements having
different design features, and the Examiner’s rejection contemplates
modifying the piecing elements of Eason to have a V-shape and to each
extend entirely within its respective plane. See Ans. 11—12.
Contrary to Appellants’ arguments, the fact that Harmer ’877 and
Smith exhibit certain differences and features does not detract from the fact
that the Examiner has established that Appellants’ claimed invention
represents a combination of known elements performing known functions
with predictable results. See KSR, 55 US at 417. In fact, contrary to
Appellants’ arguments, Harmer ’877 expressly states that “conventional
piercing heads” are adequate for certain excipient particles sizes, and
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Appellants’ claims are not limited to the specific range of particles sizes for
which Harmer ’877 proposes an improvement over other piercing-head
configurations. Moreover, even if the specific shape of Harmer ’877’s
piercing elements were critical to the overall function of Harmer’s system,
Appellants’ arguments do not present evidence that modifying the piercing
elements of Eason as contemplated by the Examiner’s rejection would have
yielded unpredictable results or otherwise required more than a routine
exercise of a skilled artisan. See KSR, 55USat417.
Having considered the Examiner’s rejection in light of each of
Appellants’ arguments and the evidence of record, we disagree with
Appellants and agree with the Examiner. We adopt as our own the
Examiner’s findings, conclusions, and reasons consistent with this Decision,
and we sustain the Examiner’s rejection of independent claim 1, as well as
dependent claims 2—13 which Appellants do not separately address.
DECISION
For the above reasons, we affirm the Examiner’s rejection of claims
1-13.
No time period for taking any subsequent action in connection with
this appeal maybe extended. 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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