Alfred E. Tiefenbacher GmbH & Co. KG et al.

Patent Trials and Appeals Board

May 15, 2020

15363317 - (D) (P.T.A.B. May. 15, 2020)

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.
15/363,317 11/29/2016 Claudia Meyer HAMWIT 3.0F-002 3425
530 7590 05/15/2020
LERNER, DAVID, LITTENBERG,
KRUMHOLZ & MENTLIK
20 Commerce Drive
Cranford, NJ 07016
EXAMINER
PALLAY, MICHAEL B
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
05/15/2020 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):
eOfficeAction@lernerdavid.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CLAUDIA MEYER, ROBERT PRICE, and
JAGDEEP SHUR1
____________

Appeal 2019-005581
Application 15/363,317
Technology Center 1600
____________

Before DEBORAH KATZ, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Alfred E. Tiefenbacher GMBH &
CO. KG and Nanopharm LTD. as the real parties-in-interest. App. Br. 1.
Appeal 2019-005581
Application 15/363,317

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1–12 as unpatentable under 35 U.S.C.
§ 103 as being obvious over Walz et al. (US 2002/0106332 A1, August 8,
2002).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to a simple, robust and effective
process for preparing a dry powder inhalation formulation containing at least
one drug. Abstr.

REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A process for preparing a dry powder inhalation
formulation containing tiotropium bromide and a lactose carrier,
comprising the steps:

a) splitting the lactose carrier into a first, a second and
a third portion,

b) mixing the first and the second portion of the lactose
carrier and the tiotropium bromide by

i) placing the first portion of the lactose carrier
in a mixer to obtain a first layer,

ii) placing the entire tiotropium bromide on top
of the first lactose layer to obtain a second
layer,

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iii) placing the second portion of the lactose
carrier on top of the second layer to obtain a
third layer,

iv) blending the three-layered composition
obtained in step (iii) to obtain a preblend,

v) optionally sifting the preblend,

c) mixing the preblend obtained in step (b) and the
third portion of the lactose carrier to obtain the dry
powder inhalation formulation, and

d) optionally sifting the dry powder inhalation
formulation.

App. Br. 10.

ISSUES AND ANALYSIS
We agree with, and expressly adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are obvious over the cited prior art.
We address below the arguments raised by Appellant.

Issue 1
Appellant argues that the Examiner erred because Walz neither
teaches nor suggests the limitation of claim 1 reciting: “mixing the preblend
obtained in step (b) and the third portion of the lactose carrier to obtain the
dry powder inhalation formulation.” App. Br. 5.

Analysis
The Examiner finds that Walz teaches a process for producing
powdered preparations for inhalation, in which lactose monohydrate is the
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most particularly preferred excipient and tiotropium bromide is a particularly
preferred active substance. Final Act. 4 (citing Walz Abstr., ¶¶ 24, 28). The
Examiner finds that Walz teaches that the process for preparing the inhalable
powder comprises N+m substantially equal layers of an excipient having a
larger particle size distribution and N substantially equal layers of an active
substance having a smaller particle size distribution, added in alternate
layers into a suitable mixing vessel. Id. (citing Walz ¶ 8, claim 1). The
Examiner finds that Walz teaches that N is an integer greater than 0 and that
m is 0 or 1. Id. The Examiner also finds that Walz teaches that, after all the
excipient and active components have been added, the 2N+m layers of the
two components are mixed together using a suitable mixer. Id.
The Examiner acknowledges that Walz does not teach mixing a third
portion of active substance after obtaining the mixture discussed above, or
mixing a third fraction of coarse excipient after obtaining the excipient
mixture discussed above, as claimed. Final Act. 4. However, the Examiner
reasons, changes in a sequence of adding ingredients, and selecting an order
of mixing ingredients, is prima facie obvious. Id. (citing MPEP
§ 2144.04(1V)(C)). Therefore, the Examiner concludes, it would have been
obvious to a person of ordinary skill in the art to mix therein any portion of
the excipient after first obtaining the mixture discussed above, thereby
requiring initially setting aside that portion of the excipient. Id.
Appellant argues that the claimed third portion of excipient is added
after the claimed three-layered composition is mixed to form a preblend.
App. Br. 5. Therefore, Appellant contends, the third portion of excipient is
not one of the layers of the layered composition because it is not present
until the layered composition has already been converted into a preblend.
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Id. According to Appellant, Walz cannot disclose the third portion of
excipient because Walz neither teaches nor suggests adding any component
to its inhalation composition that is not a layer of the layered composition.
Id.
Appellant asserts that Walz teaches adding 91 alternating layers of
tiotropium bromide monohydrate and excipient into a mixing container and
then subsequently mixing all 91 layers together, and that Walz does not
teach adding any additional excipient or other additives thereafter. App. Br.
5 (citing Walz ¶¶ 64–65).
Furthermore, argues Appellant, even were the third portion of
excipient considered to be a layer of the layered composition, it is still not
within the scope of the teachings of Walz. Final Act. 5. Appellant points
out that the Examiner acknowledges that Walz’s composition is based upon
the relationship between the number of layers of active agent and the
number of layers of excipient, with N equal to the number of layers of
active, and N+m equaling the layers of excipient. Id. (citing Walz ¶¶ 8–10).
Therefore, Appellant contends, Walz teaches that 2N+m equals the total
layers of active plus layers of excipient, where N is an integer greater than 0,
and m equals 0 or 1. Id. Appellant asserts that Walz therefore requires that
the number of excipient layers be either equal to, or one greater than, the
number of active material layers. Id. Therefore, Appellant asserts, even if
the third portion of excipient can be considered a layer, the claimed method
produces two more layers of excipient than of active, placing the claimed
subject matter outside the scope of Walz’s teachings. Id.
We are not persuaded by Appellant’s arguments. We acknowledge
Appellant’s point that Walz does not expressly teach step (c), as recited in
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Appellant’s claim 1. Nevertheless, Walz teaches adding alternating layers of
carrier and active agent prior to mixing – the steps of claim limitations (a)
and (b). We are not persuaded that adding additional carrier after the initial
mixing of ingredients would not have been obvious to a person of ordinary
skill as an additional step to the order of steps recited by Walz.
Our reviewing court has repeatedly held that the order of the steps
recited in a claim is not limiting upon the claim unless the order of steps is
critical to obtaining the desired result. In Gibson, the Federal Circuit held
that:
We think the proper sequence of adding the three ingredients to
obtain the most satisfactory mixture of three constituents is
within the expected skill and judgment of a mechanic and such
choice of sequence does not involve invention in making a mix
of the constituents named in [the prior art reference].

In re Gibson, 39 F.2d 975, 976 (C.C.P.A. 1930). And in Burhans, the court
held that:
Appellant contends that the references taken singly or together
do not teach his characteristic four steps which are new in the art
and which are necessary to obtain the desired result. There is no
merit in the point here in the absence of any proof in the record
that the order of performing the steps produces any new and
unexpected results.

In re Burhans, 154 F.2d 690, 692 (C.C.P.A. 1946). Appellant adduces no
evidence of record to show that the claimed addition of a final layer of
carrier, and mixing it with the preblend produces an effect not already
demonstrated by Walz, let alone a new and unexpected result.
We conclude that the addition of a repetitious step of adding a layer of
withheld carrier to the preblend, and mixing, as recited in limitation (c) of
claim 1 does not rise to the requisite level of inventiveness necessary to
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overcome the Examiner’s prima facie conclusion that the claims are obvious
over Walz.

Issue 2
Appellant argues that the Examiner erred because Walz fails to teach
or suggest two mixing steps. App. Br. 6.

Analysis
Appellant argues that claim 1 recites a first mixing step (step (b)) to
form a preblend, and then recites a second mixing step (step (c)) of adding a
third portion of excipient, and mixing again to form an inhalation
composition. App. Br. 6. Appellant contends that the active agent and first
and second excipient portions are therefore subjected to two mixing
processes, the third portion of excipient is only mixed once. Id.
Appellant contends that Walz fails to teach the claimed two mixing
steps but, rather, teaches adding 2N+m layers of active and excipient into a
mixing container and then mixing only after all 2N+m layers have been
added. App. Br. 6 (citing Walz ¶¶ 8, 64–65). Appellant acknowledges that
Walz teaches that the mixed composition may optionally be subsequently
sieved and mixed again. Id. (citing Walz ¶¶ 64–65). However, Appellant
argues, because Walz does not teach adding any additional excipient or other
material after the first mixing occurs (unlike in the claimed process), all of
the ingredients of Walz are mixed the same number of times. Id. Therefore,
Appellant argues, Walz does not teach forming a preblend, which lacks
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components of the finished product, as claimed, but merely discloses
forming a complete inhalation composition. Id.
Appellant argues that the Examiner’s reliance on MPEP
§ 2144.04(1V)(C) is misplaced, because the claimed steps are not simply a
reordering or “reversal” of the steps of Walz, as they were in Ex parte Rubin
128 USPQ 440 (Bd. App. 1959). App. Br. 6. Rather, Appellant argues, the
claimed process includes an entirely new step that is missing from those
taught by Walz, viz., introducing additional excipient in a second mixing
step such that some ingredients are subjected to more mixing processes than
others. Put another way, Walz does not disclose forming an unfinished
preblend, lacking components of the finished product, as is claimed. Id. at
6–7.
Appellant argues further that the order of process steps in a claim may
be controlling and may limit a claim when the order of claimed steps is
necessary to practice the claimed invention. App. Br. 7 (citing Mformation
Techs., Inc. v. Research in Motion, Ltd., 764 F.3d 1392, 1398–99 (Fed. Cir.
2014); TALtech Ltd. v. Esquel Apparel, Inc., 279 F. App’x 974, 978 (Fed.
Cir. 2008)). Appellant contends that the claimed introduction of additional
excipient in a second mixing step is necessary to practice the claimed
invention because content uniformity “largely depends on the mixing
process used” and is a “crucial factor in highly active drug formulations,”
such as those containing tiotropium bromide, because these “formulations
typically contain a very small portion of active ingredient.” Id. (citing Spec.
¶¶ 5, 6).
We are not persuaded by Appellant’s arguments. As we have
explained supra, we do not find that the addition of a repetitive step of
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adding a layer of carrier and mixing is sufficiently inventive to overcome the
Examiner’s prima facie conclusion that the claims are obvious. Appellant
argues that the order of process steps in a claim may be controlling and may
limit a claim when the order of claimed steps is necessary to practice the
claimed invention. App. Br. 7 (citing, e.g., Mformation Techs., 764 F.3d at
1398–99). But Appellant adduces no evidence of record to demonstrate that
the additional layering of carrier and mixing steps are necessary to practice
the claimed invention when compared to the method taught by Walz.
Appellant’s Specification discloses that: “It was an objective of the
present invention to provide a process for preparing a dry powder inhalation
formulation showing excellent flow characteristics and content uniformity.”
Spec ¶ 16. The Specification further discloses that: “It has been found that
excellent content uniformity was achieved if the weight ratio first
portion/second portion/third portion of the lactose carrier is 7/2/1, 5/1/4,
5/2/3, 4/1/5, or 2/1/7.” Id. at ¶ 26. However, Walz teaches that: “The
inhalable powders which may be obtained by the preparation process
according to the invention are characterized by an exceptional degree of
homogeneity in terms of uniformity of content.” Walz ¶ 29. We cannot
discern, nor does Appellant adduce, any significant difference in the results
obtained by Walz and those obtained via the method claimed by Appellant.
As such, we do not find that the order of steps recited in the claims are
necessarily limiting upon the claim.

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Issue 3
Appellant argues that the Examiner erred in concluding that the claims
are prima facie obvious over Walz because the range of layers taught by
Walz overlaps the claimed number of layers. App. Br. 7.

Analysis
Appellant argues that, even if the claimed composition is within the
range disclosed by Walz, no person of ordinary skill in the art would have
been motivated to choose such a small number of layers in order to achieve a
high content uniformity. App. Br. 7.
Appellant argues that the prior art, considered as a whole, teaches
using high numbers of alternating layers in order to achieve optimum
content uniformity. App. Br. 8. Appellant asserts that the Specification
discloses that the methods of the prior art achieved favorable content
uniformity by mixing high numbers of alternating layers of active and carrier
compounds. Id. (citing Spec. ¶¶ 12–15). In general, argues Appellant, the
prior art teaches that to obtain high content uniformity, it is necessary to
include, for example, 30 or more, or up to 152 layers. Id.
Appellant contends that Walz similarly teaches that the number of
layers is directly proportional to content uniformity; teaching that, as the
former increases, so does the latter. App. Br. 8. Appellant points out that
the Examiner acknowledges this teaching, finding that a skilled artisan “may
appreciate from the disclosure of Walz et al. that the greater the N, the more
homogeneous the powder mixture.” Id. (quoting Final Act. 7). Appellant
argues that Walz specifically teaches that it is preferable to include more
than 20 layers, more preferably more than 25 layers, and most preferably
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more than 30 layers. Id. (citing Walz ¶ 15). According to Appellant, Walz
suggests using even higher numbers of layers to maximize content
uniformity, stating that “the process can … be carried out with N>60 to
achieve the desired effect of the maximum possible homogeneity of the
powder mixture.” Id. (citing Walz ¶ 15).
Appellant argues that Walz thus teaches a potentially infinite range of
possible numbers of layers, extending from a lower limit of 2 layers (e.g., N
= l, m = O, N+m = l, and 2N+m = 2) to an infinitely high number of layers
(e.g., N > 60). App. Br. 8. Appellant contends that Walz provides several
exemplary embodiments, in each of which is used, in conjunction
triotropium bromide as the active agent, “46 or 45 layers” of the excipient
and active, respectively, with a tolerance of plus or minus nine layers. Id.
(citing Walz ¶ 64). Appellant calculates that Walz therefore teaches using
91 total layers in a tiotropium bromide inhalation powder, in contrast to the
three layers recited in claim 1. Id. at 8–9.
We are not persuaded. We agree with Appellant that Walz teaches
that a larger number of alternating layers of agent and carrier are preferable,
particularly in preparing large batches:
In the process according to the invention, N is naturally
dependent inter alia on the total quantity of powder mixture to be
produced. When producing smaller batches, the desired effect of
high homogeneity in the sense of uniformity of content can be
achieved with a smaller N. In principle, it is preferable according
to the invention if N is at least 10 or more, more preferably 20 or
more, better still 30 or more. The greater N is and, as a result, the
greater the total number of layers of the powder fractions formed,
the more homogeneous the powder mixture becomes in the sense
of uniformity of content.

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Walz ¶ 9. Nevertheless, the scope of Walz’s teachings includes the small
numbers of layers recited in Appellant’s claims and does not expressly
exclude the limited number of layers recited in Appellant’s claim 1.
Because “‘all disclosures of the prior art, including unpreferred
embodiments, must be considered[,]’” we are not persuaded that a person of
ordinary skill in the art would have been discouraged or diverted by the
teachings of Walz from practicing Appellant’s claimed invention. See Merck
& Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(quoting In re Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)).
Because we find that claim 1’s addition of a repetitive step of adding
another layer of carrier and mixing it into the preblend would have been
obvious to a person of ordinary skill in the art, we affirm the Examiner’s
rejection of the claims.

CONCLUSION
The rejection of claims 1–12 as unpatentable under 35 U.S.C. § 103 is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).

AFFIRMED

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–12 103 Walz 1–12