Ex Parte Haeberlin et al

Patent Trial and Appeal Board

Nov 15, 2018

14960472 (P.T.A.B. Nov. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/960,472 12/07/2015 Barbara Haeberlin
1095 7590 11/19/2018
NOVARTIS PHARMACEUTICAL CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
ONE HEAL TH PLAZA 433/2
EAST HANOVER, NJ 07936-1080
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.
P AT050286-US-CNT03 7429
EXAMINER
DRAPER, LESLIE A ROYDS
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
11/19/2018 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):
phip.patents@novartis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BARBARA HAEBERLIN, FRANK STOW AS SER, WOLFGANG
WIRTH, ANTON BAUMBERGER, STEPHEN ABEL,
SEBASTIAN KAERGER, and THOMAS KIECKBUSCH
Appeal2017-010593
Application 14/960,4 72 1
Technology Center 1600
Before DONALD E. ADAMS, MICHAEL J. FITZPATRICK, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge ADAMS
Opinion Dissenting filed by Administrative Patent Judge FITZPATRICK
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1---6 (Final
Act. 2 2). Examiner entered a rejection under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify "Novartis AG" as the real party in interest (App. Br. 2).
2 Examiner's April 21, 2016 Final Office Action.
Appeal2017-010593
Application 14/960,472
STATEMENT OF THE CASE
Appellants' disclosure "relates to organic compounds and their use as
pharmaceuticals, or more specifically a process for preparing dry powders of
glycopyrronium salts" (Spec. 1 ). Claim 1 is representative and reproduced
below:
1. A process for preparing a dry powder formulation of a
glycopyrronium salt for inhalation that comprises the steps of
(a) mixing a glycopyrronium salt and 3 to 5% by mass of
magnesium stearate, based on the total amount of
glycopyrronium salt and magnesium stearate, to give a
homogeneous blend; (b) micronising the blend; and ( c)
admixing carrier particles to the micronized blend to form a dry
powder formulation, wherein the carrier particles are mixed
with the blend of micronized glycopyrronium salt and
magnesium stearate in a ratio of 200: 1 to 20: 1 by mass.
(App. Br. 3 8 (emphases added).)
Claims 1---6 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Morton 4 and Bannister. 5
ISSUE
Has Examiner established that the combination of Morton and
Bannister makes obvious a method of preparing a dry powder formulation of
glycopyrronium salt that comprises, inter alia, the steps of mixing
glycopyrronium salt and magnesium stearate (MgSt) to form a homogenous
blend and micronizing this blend?
3 Appellants' April 6, 2017 Appeal Brief.
4 Morton et al., WO 2005/025536 A2, published Mar. 24, 2015.
5 Bannister et al., WO 01/76575 A2, published Oct. 18, 2001.
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Application 14/960,472
ANALYSIS
As Appellants explain, "[ a ]t the heart of this [ A Jppeal is the
disagreement between Appellant[ s] and the Examiner with respect to the
interpretation of the language of claim 1 and the teachings of the Morton
reference" (Reply Br. 6 2). Therefore, we begin our obviousness analysis
with an interpretation of Appellants' claim 1. 7
Initially, we recognize Examiner's finding that "the term
'homogenous blend' is understood in the context of the present invention to
be a thorough mixture of the two components (the active drug-
glycopyrrolate, and the additive material-MgSt), to produce a cohesive
mixture" (Ans. 9).
We further recognize that "[ u ]nless the steps of a method actually
recite an order, the steps are not ordinarily construed to require one."
Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342 (Fed.
Cir. 2001); see Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322
(Fed. Cir. 1999) (stating that "not every process claim is limited to the
performance of its steps in the order written"). Nevertheless, an order "can
ensue when the method steps implicitly require that they be performed in the
order written." Interactive Gift, 256 F.3d at 1342. Such an implicit order of
claimed method steps was found in Mantech, wherein our reviewing court
held "that the sequential nature of the claim steps is apparent from the plain
meaning of the claim language." Mantech Envtl. Corp. v. Hudson Envtl.
6 Appellants' August 4, 2017 Reply Brief.
7 Appellants' claims 2-6 depend directly or indirectly from Appellants'
claim 1 (see App. Br. 8).
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Application 14/960,472
Servs., Inc., 152 F.3d 1368, 1376 (Fed. Cir. 1998). In this regard, the
Mantech court explained:
Step (a) provides the wells. No monitoring or injecting of the
groundwater can occur until wells are provided; hence, step (a)
must be performed first. Step (b) introduces acetic acid, via the
wells provided in step (a), into the groundwater of the
contaminated region. Hence, in order to accomplish step (b ),
the wells of step (a) must already have been provided. Step ( c)
introduces an aqueous solution of ferrous ion into said
groundwater region for mixing with "said acidified
groundwater". . . . In order for the aqueous solution to mix with
the acidified groundwater, the acid must have already mixed
with the groundwater to form acidified groundwater. Hence
step (b) necessarily comes before step ( c ). Step ( d) introduces a
treating flow of hydrogen peroxide solution into the
groundwater. The hydrogen peroxide solution undergoes a
Fenton-like reaction "in the presence of said acidic conditions
and said ferrous ion." Because the acidic conditions and the
ferrous ion must be present before the hydrogen peroxide can
undergo the Fen ton-like reaction, step ( d) must come after both
steps (b) and ( c ).
Id. at 1375-76 (emphasis omitted) (footnote omitted).
On this record, Appellants' claim 1 requires, inter alia, the steps of (a)
preparing a homogenous blend by mixing glycopyrronium salt and
magnesium stearate and (b) micronizing the homogenous blend. By analogy
to Mantech, Appellants' homogenous blend cannot be micronized before it
is prepared. Thus, Appellants' claimed method step (a) must come before
Appellants' method step (b) (see App. Br. 8). Therefore, we are not
persuaded by Examiner's assertion that Appellants' "claims do not explicitly
require that the mixing step to form a homogenous blend occurs 'prior to"'
the step of micronizing the homogenous blend (Ans. 8), because the order is
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Application 14/960,472
implied. As Appellants make clear "[t]he plain reading of the claims
necessitates sequential performance of the steps" (Reply Br. 2).
Morton, as relied upon by Examiner, discloses a two-step process,
wherein a drug is jet-milled "on its own" and then this jet-milled drug is co-
jet milled with an additive material, e.g., magnesium sterate, to coat "the
small active particles with ... additive material" (Morton 27:4--9; id. at
19: 15-16 ("[ a ]dvantageously, the additive material comprises a metal
stearate"); see Final Act. 3--4 ). Although Morton discloses that the product
produced by co-jet milling a jet-milled drug with an additive material may
be further mixed with a carrier, 8 Examiner failed to identify, and we do not
find, a disclosure in Morton of mixing a drug with an additive material, such
as magnesium sterate, to form a homogenous blend prior to milling such a
homogenous blend, as required by Appellants' claimed invention. To be
sure, Examiner fails to identify any portion of Morton that discloses mixing
two reagents to form a homogenous blend. Examiner further failed to
identify a disclosure in Bannister that makes up for this deficiency in Morton
(see Ans. 4; cf Reply Br. 3 ("Morton ... fails to disclose the first step of the
claimed process which requires the mixing of the glycopyrronium salt and
magnesium stearate to form a homogenous blend prior to micronizing the
mixture"); App. Br. 6 (Bannister fails to make up for the deficiencies in
Morton).
Although Examiner asserts that Morton "explicitly teaches a step of
blending the previously jet-milled active drug (in this case, glycopyrrolate)
8 See Morton 20: 17-19 ("composite active particles produced by co-jet
milling ... are mixed with carrier particles made of an inert excipient
material"); see also Final Act. 4.
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with the additive material ... [, e.g., magnesium sterate,] and thenjet
milling the blend to coat the drug particles with the additive material,"
Examiner fails to identify, and we do not find, such a mixing or blending
step in Morton (Final Act. 4; see also id. at 3-5; Ans. 3 (citing Morton 27:4--
9 and 18-22); cf Reply Br. 3 (although the comprising language of
Appellants' claims "allows for the possibility of prior steps such as pre[-]
milling the active particle, ... Morton ... fails to disclose the first step of
the claimed process which requires the [preparation ofJ ... a homogenous
blend prior to micronizing the mixture")). See In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006) ("[R]ejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness."). Thus, we agree with Appellants' contention
that the combination of Morton and Bannister "fail[ s] to teach or suggest
mixing glycopyrronium salt and magnesium stearate to give a homogenous
blend prior to micronization" (Reply Br. 2).
Examiner also appears to assert that co-jet milling glycopyrrolate with
magnesium sterate will, at some point in the milling process, inherently
result in the creation of a homogenous blend of the two reagents, thereby
meeting the first step of Appellants' claimed method and any subsequent
milling of the combined reagents will satisfy the second step of Appellants'
claimed method (see Ans. 8 (Morton "expressly teaches that the process of
jet milling achieves 'blending of the active and additive particles' so as to
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generate the coated particles (see, e.g., [Morton,] p.25, 1.25-26)"); 9 see also
id. at 8-9 ("[ t ]he fact that the homogenous blending occurs subsequent to the
mixing step but during the jet-milling process is immaterial because the
instant claims do not expressly require that the active drug and additive
material are 'pre-mixed' to form a homogenous blend prior to initiating the
micronization process")). Examiner, however, failed to establish an
evidentiary basis on this record to support a conclusion that any blending of
reagents during a milling process inherently produces a homogenous blend
or, assuming that a homogenously blended product is formed during the
milling process, the milling process will inherently be continued beyond the
formation of a homogenously blended product. In this regard, we note that
Morton discloses only that co-jet milling a drug, e.g., glycopyrrolate, with an
additive material, e.g., magnesium sterate results in coating "the small active
[drug] particles with ... additive material" (Morton 27:4--9). Examiner thus
failed to establish an evidentiary basis on this record to support a conclusion
that a person of ordinary skill in this art would have considered the coating
of one reagent with another represents a homogenous blend, even if
Examiner's definition ofhomogenous is adopted (see Ans. 9) or that, if such
a coated product represents a homogenously blended product, that this
coated product is further milled which, for the reasons discussed above,
would be required by Appellants' claimed method. Inherency "may not be
established by probabilities or possibilities. The mere fact that a certain
9 Morton discloses "[i]n one embodiment, the jet milling is carried out at a
grinding pressure ofbetween 0.1 and 3 bar, to achieve blending of the active
and additive particles" (Morton 25:25-26).
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thing may result from a given set of circumstances is not sufficient." In re
Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted).
For the reasons set forth above, we find that Appellants' claimed
method requires the preparation of a homogenous blend of reagents prior to
the claimed micronization step, not the speculative creation of a
homogenous blend at some point during a micronization step. Therefore, we
once again find ourselves in agreement with Appellants' contention that the
combination of Morton and Bannister "fail[ s] to teach or suggest mixing
glycopyrronium salt and magnesium stearate to give a homogenous blend
prior to micronization" as is required by Appellants' claimed method (see
Reply Br. 2).
CONCLUSION
Examiner failed to establish that the combination of Morton and
Bannister makes obvious a method of preparing a dry powder formulation of
glycopyrronium salt that comprises, inter alia, the steps of mixing
glycopyrronium salt and magnesium stearate (MgSt) to form a homogenous
blend and micronizing this blend. Therefore, the rejection of record is
reversed.
REVERSED
8
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BARBARA HAEBERLIN, FRANK STOW AS SER, WOLFGANG
WIRTH, ANTON BAUMBERGER, STEPHEN ABEL,
SEBASTIAN KAERGER, and THOMAS KIECKBUSCH
Appeal2017-010593
Application 14/960,472
Technology Center 1600
Before DONALD E. ADAMS, MICHAEL J. FITZPATRICK, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge, dissenting.
I dissent from the decision of the Board. I would affirm the
Examiner's rejection of claims 1---6.
Claim 1 recites:
1. A process for preparing a dry powder formulation
of a glycopyrronium salt for inhalation that comprises the steps
of (a) mixing a glycopyrronium salt and 3 to 5% by mass of
magnesium stearate, based on the total amount of
glycopyrronium salt and magnesium stearate, to give a
homogeneous blend; (b) micronising the blend; and ( c)
admixing carrier particles to the micronized blend to form a dry
powder formulation, wherein the carrier particles are mixed
with the blend of micronized glycopyrronium salt and
magnesium stearate in a ratio of 200: 1 to 20: 1 by mass.
Appeal2017-010593
Application 14/960,472
Appeal Br. 8. Thus, claim 1 is a process claim. It recites three steps-(a),
(b ), and ( c }-but does not recite an order for them.
When presented with such a claim, the steps should not ordinarily be
construed to require an order. Interactive Gift Exp., Inc. v. Compuserve Inc.,
256 F.3d 1323, 1342--43 (Fed. Cir. 2001) ("Unless the steps of a method
actually recite an order, the steps are not ordinarily construed to require
one."). In Interactive Gift, the Federal Circuit construed such a process
claim to not require its steps to be performed in a particular order because
"nothing in the claim or the specification directly or implicitly require[ d]
such a narrow construction." Id.
Here, the majority state that "Appellants' homogenous blend cannot
be micronized before it is prepared. Thus, Appellants' claimed method
step (a) must come before step (b )." Supra 4. However, claim 1 should not
be construed to preclude simultaneous or overlapping performance of
steps (a) and (b). In other words, claim 1 does not have a negative limitation
precluding micronizing of a non-homogenous blend. So long as a
homogenous blend ultimately is micronized ( even for a short period of
time), step (b) is satisfied. Thus, I agree with the Examiner's construction
that claim 1 does not "require that the active drug and additive material are
'pre-mixed' to form a homogeneous blend prior to initiating the
micronization process." Ans. 8-9.
But ultimately, for the majority (as opposed to Appellants), the issue
is not whether Morton discloses step (a) prior to step (b) but whether Morton
discloses step (a) at all. Supra 5 ("To be sure, Examiner fails to identify any
portion of Morton that discloses mixing two reagents to form a homogenous
blend.").
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With regard to step (a), the Examiner cited Morton's teaching of co-
jet milling glycopyrronium bromide and MgSt. Final Act. 4. In response to
pre-appeal arguments by Appellants, the Examiner explained as follows:
Applicant is incorrect that these teachings in Morton et
al. do not adequately provide for a mixing step of
glycopyrronium bromide and MgSt to provide a homogenous
blend. Morton et al. explicitly teaches a step of blending the
previously jet-milled active drug (in this case, glycopyrrolate)
with the additive material (Morton et al. explicitly discloses that
Mg St is the preferable additive material to be used) and then jet
milling the blend to coat the drug particles with the additive
material, which clearly meets Applicant's claimed steps of
mixing the glycopyrronium salt with the recited amount of
MgSt to provide a homogenous blend and then micronizing the
blend.
Id.; see also In re Schaumann, 572 F.2d 312, 317 (CCPA 1978) (anticipation
does not require ipsissimis verbis teaching).
In their Appeal Brief, Appellants never challenge whether Morton
discloses step (a). They challenge instead whether Morton discloses step (a)
"prior to" micronizing. Appeal Br. 5 ("The References fail to teach or
suggest mixing glycopyrronium salt and magnesium stearate to give a
homogenous blend prior to micronization."), 6 ("Appellant respectfully
submits that Morton still fails to disclose the first step of the claimed process
which requires the mixing of the glycopyrronium salt and magnesium
stearate to form a homogenous blend prior to any micronization step.").
Nonetheless, in the Answer, the Examiner sufficiently rebuts any such
argument. See Ans. 9 ("If it is Appellant's position that Morton et al. is
allegedly deficient for not explicitly teaching that the blending of the active
drug glycopyrrolate) with the additive material (Mg St) is 'homogeneous' per
se, then this argument is unavailing."). In that regard, the Examiner
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Application 14/960,472
expressly construes the term "homogenous" and shows that Morton
discloses step (a), stating as follows:
The term "homogeneous" as used in Appellant's claim 1
is a relative term to define the degree of uniformity of the
mixture, and is not particularly defined in the accompanying
specification to require a specific degree of distribution of the
components within the mixture, or a specific manner of mixing
that results in a particular degree of uniformity. Applying the
broadest reasonable interpretation standard stipulated by MPEP
§ 2111, the term "homogenous blend" is understood in the
context of the present invention to be a thorough mixture of the
two components (the active drug - glycopyrrolate, and the
additive material - MgSt), to produce a cohesive mixture, which
is exactly what is produced in Morton et al. for micronization
via his blending and jet-milling process. Note, further, that
Morton et al. explicitly teaches the purpose of his mixing step
to combine the two components ( active drug and additive
material) for further jet-milling, which necessarily requires a
thorough blending of the two components to provide a cohesive
mixture in which the active drug particles are coated with
additive material and micronized (see, e.g., p.27, 1.4--9).
Id.; see also id. at 8 (Morton "teaches mixing the jet-milled active drug -
glycopyrrolate - with the additive material - MgSt - to form a mixture that is
then subjected to co-jet milling, a process that necessarily thoroughly blends
and micronizes the blended mixture.").
In their Reply Brief, Appellants again do not challenge the
Examiner's construction of "homogeneous" or the Examiner's finding that
Morton teaches step (a). Instead, Appellants challenge whether Morton
teaches step (a) "prior to" step (b ). See Reply Br. 2 ("The References fail to
teach or suggest mixing glycopyrronium salt and magnesium stearate to give
a homogenous blend prior to micronization."), 3 ("Appellant respectfully
submits that Morton still fails to disclose the first step of the claimed process
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which requires the mixing of the glycopyrronium salt and magnesium
stearate to form a homogenous blend prior to micronizing the mixture.").
The Examiner found that Morton's co-jet milling would provide a
"homogenous blend" of the co-jet milled components. In my view,
Appellants have not shown any error in this finding.
Thus, I would sustain the rejection.
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