CHIESI FARMACEUTICI S.p.A.

Patent Trials and Appeals Board

Feb 20, 2020

14791553 - (D) (P.T.A.B. Feb. 20, 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.
14/791,553 07/06/2015 Sauro BONELLI 456362US68CONT 4588
22850 7590 02/20/2020
OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
02/20/2020 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):
OBLONPAT@OBLON.COM
iahmadi@oblon.com
patentdocket@oblon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SUARO BONELLI, FRANCESCA USBERTI, and
ENRICO ZAMBELLI
__________

Appeal 2019-002216
Application 14/791,5531
Technology Center 1600
__________

Before DONALD E. ADAMS, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition comprising glycopyrronium bromide dissolved
in HFA-134a and ethanol, which have been rejected as obvious and/or
provisionally for obviousness-type double patenting. Oral argument was
heard on February 3, 2020. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 We use the word “Appellant” to refer to “Applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Chiesi
Farmaceutici S.p.A. (Appeal Br. 2.)
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STATEMENT OF THE CASE
“Glycopyrronium bromide (also known as glycopyrrolate) is a
muscarinic M3 anticholinergic agent.” (Spec. 1.) This compound has “been
reported to be effective in the treatment of asthmatic symptoms.” (Id.) It
has also been disclosed for use in treating chronic obstructive pulmonary
disease as a dry powder formulation “suitable for delivery by means of a dry
powder inhaler (DPI).” (Id. at 2.)
“One of the drawbacks of DPIs is that insufficient patient inhalation
flow rates may lead to reduced dose delivery and incomplete deaggregation
of the powder, leading to unsatisfactory device performance.” (Id.)
Pressurized metered dose inhalers (pMDIs), unlike DPIs, “use propellant to
expel droplets containing the pharmaceutical product to the respiratory tract
in an aerosol.” (Id.) Appellant’s invention is “to provide novel
pharmaceutical aerosol solution formulations comprising glycopyrronium
bromide, intended for use in [pMDIs].” (Id.)

Claims 1, 2, 5–9, 18, 19, and 38–41 are on appeal.2 Claim 1 is
representative and reads as follows:
1. A pharmaceutical composition for use with a pressurized
metered dose inhaler, comprising glycopyrronium bromide
dissolved in HFA-134a and ethanol, wherein:
the composition comprises an amount of hydrochloric
acid equivalent to 0.005 to 1.0 μg/μl of 1M hydrochloric acid;

2 Claims 10–12, 14–17, and 20–37 remain pending but are withdrawn from
consideration as being directed to non-elected subject matter. (Appeal Br.
2.)
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the composition comprises glycopyrronium bromide in
an amount of 0.015 to 0.04 % w/w of the composition;
the composition comprises ethanol in an amount of 10 to
15% w/w of the composition; and
the composition comprises HFA-134a in an amount of 85
to 90% w/w of the composition.
(Appeal Br. 49.)
The prior art relied upon by the Examiner is:
Name Reference Date
Lewis US 2006/0257324 A1 Nov. 16, 2006
Gerhart US 2011/0132355 A1 June 9, 2011
Keller US 6,475,467 B1 Nov. 5, 2002
Lewis EP 1157689 A1 Nov. 28, 2001
Goede WO 2005/074900 A2 Aug. 18, 2005
Glycopyrronium Bromide, Martindale: The Extra Pharmcopoeia 532
(Reynolds, 29th ed. 1989)

The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 2, 5–9, 18, 19, and 38–41 under 35 U.S.C. § 103(a) as
unpatentable over Lewis ’324, Gerhart, Keller, and Reynolds.
Claims 1, 2, 5–9, 18, 19, and 38–41 under 35 U.S.C. § 103(a) as
unpatentable over Lewis ’689, Goede, Keller, and Reynolds.
Claims 1, 2, 5–9, 18, 19, and 38–41 provisionally for obviousness-
type double patenting over claims 1–14 of US Application 14/585,533 and
Keller.3

3 The Examiner’s provisional rejection of claims 1, 2, 5–9, 18, 19, and 38–
41 for obviousness-type double patenting over claims 1–10 and 12 of US
Application 14/812,190 and Keller has been rendered moot in light of the
Appellant’s filing and the Office’s acceptance of a terminal disclaimer over
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DISCUSSION
Non-Obviousness over Lewis ’324, Gerhart, Keller, and Reynolds
The Examiner finds that Lewis ’324 teaches a composition for use in
an aerosol inhaler that is a solution including an active material, a
hydrofluoroalkane propellant such as HFA 134a, a cosolvent such as
ethanol, and an acid stabilizer, such as HCl, in a small amount. (Final
Action 4.) The Examiner notes that Lewis ’324 teaches the active ingredient
can be formoterol used alone or in combination with other compounds such
as a steroid or an anticholinergic atropine-like derivative such as
glycopyrronium bromide. (Id.) The Examiner further finds that Lewis ’324
teaches that the amount of acid used will depend on the type and
concentration of the active ingredient and it discloses that in a formulation
that includes formoterol in combination with the steroid beclometasone
dipropionate, the amount should be between 3 and 3.5 μl of 1.0 M HCl.
(Id.) The Examiner further finds that Lewis ’324 exemplifies a formulation
where formoterol is dissolved in HFA 134a containing 12% by weight of
ethanol and includes 3.1 to 3.4 μl of 1.0 M HCl and the composition had
good stability after storage at 55 ºC. (Id. (referring to Example 3).)
Moreover, according to the Examiner, Lewis ’324 discloses that “the pH of
the formulation is between 3 and 3.5 for improved stability of the
formulation (See [0043]).” (Id. at 22; Ans. 8.)

the ’190 Application (Reply Br. 1). Additionally, the Examiner’s
provisional rejection of claims 1, 2, 5–9, 18, 19, and 38–41 for obviousness-
type double patenting over claims 1–10 of US Application 14/467,101 and
Haeberlin (US 2009/0209502 A1) is moot since the ’101 Application has
been abandoned.
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According to the Examiner, “the only limitation not disclosed in
Lewis et al’s reference is the amount of glycopyrronium bromide.” (Ans. 6.)
The Examiner concludes, however, that including an amount of
glycopyrronium bromide within the claimed amount would have been
obvious to one of ordinary skill in the art in light of the disclosure of Gerhart
and Keller. (Final Action 6–8; Ans. 7–8.) In particular, the Examiner finds
that Gerhart teaches “solution formulations” of formoterol and a
glycopyrrolate salt for treating COPD, noting that those active ingredients
could be administered serially but in a time frame of less than about 30
minutes which time frame “may be considered a single dosing event.”
(Final Action 6, 7.) The Examiner further finds that Gerhart discloses a
formoterol dose of “about 0.25 μg to about 7 μg (see [0071][)]” and
glycopyrrolate “at a nominal dosage of from 25 μg to about 1600 μg (see
[0073]).” (Id.)
The Examiner finds that Keller also teaches formulations for
pulmonary administration that include formoterol and glycopyrronium
bromide. (Id. at 7.) According to the Examiner, Keller discloses “that ‘the
preferred aerosol formulations of low-dose active compounds as a rule
contain approximately 0.0001 to 0.2% by weight, in particular at most
approximately 0.1 % by weight and particularly preferably approximately
0.0001 to 0.04% by weight, of suspended active compound’ (See col. 5, line
13 to col. 6, line 4).” (Id.)
According to the Examiner,
[r]egarding the claimed concentration ranges, the references
provide adequate guidance for one of ordinary skill in the art to
deduce the desired, effective and safe amounts of each
component for the said formulations. Furthermore, as evidenced
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by Keller et al, it is known in the art to prepare formulations
with low-dose active agents.
(Id. at 8.) Stated differently, the Examiner asserts “[s]ince Gerhart and
Keller provide guidance to one of ordinary skill in the art on the suitable
amount of glycopyrronium bromide for inhalation, one of ordinary skill in
the art can easily incorporate that into the formulations of Lewis et al with a
reasonable expectation of success.” (Ans. 7.)
The Examiner further relies on Reynolds for teaching that “it is
known in the art that glycopyrronium bromide is sensitive to hydrolysis at
pH levels of above 6 and as such one of ordinary skill in the art would have
been motivated to add a small amount of a suitable acid to the formulations
to maintain the pH at below 6 for optimum stability.” (Final Action 8.)
A. “[G]lycopyrronium bromide in an amount of .015 to 0.04%
w/w of the composition”
We disagree with the Examiner’s conclusion that one of ordinary skill
in the art would have determined to use an amount of glycopyrronium
bromide within the claimed amount with a reasonable expectation of success
based on the teachings of Gerhart, Keller, and Reynolds. Professor Richard
Dalby explains in his declaration4 that Gerhart is concerned with aqueous
nebulizer formulations (Dalby Declaration ¶¶ 39, 53) and Keller is
concerned with suspension formulations for pMDIs (id. ¶¶ 41, 58).5
Professor Dalby explains that one of ordinary skill in the art would not

4 The declaration of Professor Dalby was submitted by Appellant on May
25, 2017. (Appeal Br. 9.)
5 Professor Dalby is a professor in the Department of Pharmaceutical
Sciences in the School of Pharmacy of the University of Maryland and
received a PhD in Pharmaceutical sciences from the University of Kentucky
in 1988. (Dalby Declaration ¶ 1 and Dalby Curriculum Vitae 1.)
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expect that the amounts of glycopyrronium bromide (which he refers to as
GlyBr) used together with particular amounts of formoterol in the aqueous
nebulizer formulations of Gerhart to be able to be used in a non-aqueous
pMDI of the type described in Lewis ’324, and that one of ordinary skill in
the art of formulating “could not extrapolate the amount” that should be used
together “from the perspectives of efficacy, chemical stability, and
solubility.” (Id. ¶ 55.) Professor Dalby explains that the problem of stability
of active ingredients in propellant based solution aerosol products is poorly
understood (id. ¶¶ 27–28) and balancing the physical and chemical stability
of two active ingredients in a solution composition for pMDIs “is
unpredictable and often involves compromises in considering the effects of
degradation mechanisms and interactions between the active ingredients,
excipients, and pMDI components” (id. ¶ 33). He also explains that
although “mineral acids have been used to increase chemical stability of
certain drugs,” “predicting their effect on active ingredients and excipients in
[propellant] based solutions is difficult.” (Id. ¶ 35.)
Professor Dalby indicates that in suspension compositions for pMDIs,
“solid, micronised particles of the active ingredient are suspended or
dispersed in the propellant,” thus the active ingredient must be insoluble in
the propellant but should not form powder aggregates, which is avoided by
the inclusion of surfactants. (Id. ¶¶ 21–23.) In solution compositions for
pMDI, however, explains Professor Dalby, nonvolatile components “weigh
down a formulation” and are to be avoided. (Id. ¶¶ 29–30.) In short,
Professor Dalby explains that there are different concerns for the
composition of a suspension composition for pMDI and aqueous nebulizer
compositions than there are for solution compositions for pMDI. This
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provides the backdrop for why he concludes that a person of ordinary skill in
the art would not expect the concentration or amounts of an active used in a
suspension composition for pMDI or in aqueous nebulizer compositions to
be the same amounts for use in a propellant based solution pMDI
composition or even that the amount to be used could reasonably be
extrapolated therefrom.
In light of this Declaration, Appellant argues that the Examiner’s
“rejection is based on interpretations of the cited references based on
hindsight rather than the perspective of a skilled artisan at the time of the
composition of claim 1 was invented” (Appeal Br. 9) and “overstates what a
skilled artisan would have found to be predictable” from the prior art
teachings (id. at 17–22).
Despite the Declaration evidence, the Examiner asserts that “Gerhart
and Keller provide guidance to one of ordinary skill in the art on the suitable
amount of glycopyrronium bromide for inhalation, one of ordinary skill in
the art can easily incorporate that into the formulations of Lewis et al with a
reasonable expectation of success” (Ans. 7) and “one of ordinary skill in the
art is more than capable of adjusting the amount if needed to account for the
different delivery devices and formulation types” (id.). The Examiner does
not provide any reasoning why the expert opinion that the formulation
information of Gerhart and Keller would not have been viewed by one of
ordinary skill in the art as being predictive of the amount of glycopyrronium
bromide that would have reasonably been expected to be a suitable amount
to use in the different type of formulation of Lewis ’324 that also included
formoterol dissolved in solution with HFA-134a and ethanol and HCl, or
that the amount that would have been suitable could have reasonably been
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extrapolated from those disclosures. Nor does the Examiner provide
evidence that is contrary to the Declarant’s opinion that demonstrates that
one of ordinary skill in the art does use information of disparate types of
inhalant formulations to predict the amounts that are suitable across
disparate formulations. In short, the Examiner’s position that is contrary to
the expert’s is conclusory and unsupported by evidence of record, and lacks
a reasoned explanation to disregard the expert testimony. “[R]ejections on
obviousness grounds cannot be sustained by mere conclusory statements.”
In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). For this reason alone, the
preponderance of evidence on this record fails to support the Examiner’s
conclusion of obviousness as to a composition including the claimed amount
of glycopyrronium bromide dissolved in HFA-134a and ethanol for use with
a pressurized metered dose inhaler.
B. “[A]n amount of hydrochloric acid equivalent to 0.005 to 1.0
μg/μl of 1M hydrochloric acid”
We also disagree with the Examiner’s position that because Reynolds
discloses that glycopyrronium bromide is sensitive to hydrolysis at pH levels
above 6, one of ordinary skill in the art would have found it obvious “to add
a small amount of a suitable acid to the formulations” (Final Action 8) and
thus presumably arrive at a composition that included the claimed “amount
of hydrochloric acid equivalent to 0.005 to 1.0 μg/μl of 1M hydrochloric
acid.” According to the Examiner, “the stability issues of glycopyrronium
bromide have been recognized in the art” and Lewis “the primary reference,
teach[es] formulations comprising active agents such as glycopyrronium
bromide, HFA 134, ethanol and HCl wherein the pH of the formulation is
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between 3 and 3.5 for improved stability of the formulation (See [0043]).”
(Ans. 8.)
First, contrary to the Examiner’s assertion, Lewis ’324 does not teach
an HFA-134 ethanol solution formulation that includes glycopyrronium
bromide and HCl with a pH between 3 and 3.5. Lewis ’324 identifies a
stable formoterol fumarate HFA-134 ethanol solution formulation where the
formoterol is stabilized using HCl to achieve a pH between 3 and 3.5.
(Lewis ’324 ¶¶ 43, 77.) And Lewis ’324 identifies an HFA-134 ethanol
solution that includes both formoterol fumarate and a corticosteroid
dissolved therein where HCl is also added to achieve a pH between 3 and
3.5. (Id. ¶¶ 44, 77, 102.) Lewis ’324, at best, may be said to suggest an
HFA-134 solution with formoterol fumarate and glycopyrronium bromide
fully dissolved in the formulation “where small amounts of a mineral acid
[are added] to adjust the apparent pH to between 2.5 and 5.0” or “preferably
between 3.0 and 5.0.” (Id. ¶¶ 22, 30, 31, 33, 37, 76.)
Furthermore, the discussion in Lewis ’324 about stability is that (1)
solution pMDI formulations are more physically stable than suspension
pMDI formulations (Id. ¶ 5), (2) HFA formulations of formoterol fumarate
are more stable at an apparent pH below 5.5 (id. ¶¶ 39, 94), (3) stability of
the formulations can be improved using a can “having a rolled-in rim” (Id. ¶
41), and (4) inclusion of a low volatility component in the solution
formulation can improve the stability of the formulation (Id. ¶ 43). The
stability related to pH taught by Lewis ’324, thus, is directed to stability of
formoterol in HFA solutions, and amounts of HCl (between 3.1 to 3.4 μl 1M
HCl) used to arrive at an apparent pH of less than 5.5 to achieve
formoterol’s stability in HFA. (See, e.g., id. at Examples 2–4.)
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In light of the testimony of Professor Dalby, we do not find Lewis
’324 to provide guidance with respect to whether and to what extent HCl is
needed in a solution that also includes glycopyrronium bromide to achieve a
pH of less than 5.5. Professor Dalby explains that “[i]t is not apparent
whether GlyBr will be chemically stable together with the other components
of the compositions of Lewis ’324, or whether GlyBr will cause stability
issues with the other active ingredients.” (Dalby Declaration ¶ 51.)
Regarding the complexity of multiple active ingredients in solution
compositions for pMDIs, Professor Dalby states:
When preparing solution compositions for pMDIs including
two active ingredients instead of one active ingredient,
formulation becomes significantly more complex. Both active
ingredients need to be in solution at desired dosages and stay in
solution at temperatures above and below room temperature. It
is important that no components of the formulation precipitate.
It is important that all components of the formulation have
chemical stability at temperatures above and below room
temperature. Formulations that include more excipients and/or
more drugs, present more chemical stability issues. Balancing
the stability of two active ingredients in a solution composition
for pMDIs is unpredictable and often involves compromises in
considering the effects of degradation mechanisms and
interactions between the active ingredients, excipients, and
pMDI components.
(Id. ¶ 33.) Professor Dalby further notes that the Examiner’s assertion about
adding a particular amount of GlyBr and HCl to the compositions of Lewis
’324 “is not supported by consideration of the complexities and
unpredictability involved in preparing such a formulation.” (Id. ¶ 52.) The
Examiner, just as discussed above, provides no reasoned explanation or
evidence that would suggest Professor Dalby’s testimony is unbelievable in
this regard.
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Second, Reynolds describes “[t]he compatibility of glycopyrronium
bromide with infusion solutions and additives” and in that context indicates
“[t]he stability of glycopyrronium bromide is questionable above a pH of 6.”
(Reynolds 532.) Professor Dalby confirms that Reynolds’ discussion of
questionable stability would have been understood by one of ordinary skill
in the art to refer to aqueous infusion solutions of glycopyrronium bromide
due to its sensitivity to ester hydrolysis at pH levels above 6. (Dalby
Declaration ¶¶ 43–44, 60.) He further explains:
Infusion solutions have completely different storage and
administration requirements in comparison to aerosol
formulations for inhalation. The properties of an active agent in
an aqueous formulation cannot be simply extrapolated to a non-
aqueous environment such as HFA and an organic co-solvent.
(Id. ¶ 60.) The Examiner’s assertion regarding recognition in the art of
“stability issues of glycopyrronium bromide” fails to address (1) the fact that
the stability issue is with respect to a wholly different environment than the
non-aqueous solution formulations of Lewis ’324 and (2) the testimony of
Professor Dalby that the properties in Reynolds cannot be simply
extrapolated to the non-aqueous environment of the formulations of Lewis
’324. That is, the Examiner provides no reasoned explanation as to why one
of ordinary skill in the art would have modified the amount of HCl taught to
be used in a formoterol non-aqueous HFA-ethanol formulation, i.e., between
3.1 to 3.4 μl 1M HCl, to be within the claimed “0.005 to 1.0 μg/μl of 1M
hydrochloric acid” with a reasonable expectation of success. Thus, for this
additional reason, we conclude that the preponderance of evidence on this
record fails to support the Examiner’s conclusion of obviousness.
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We, therefore, reverse the Examiner’s rejection of claims 1, 2, 5–9,
18, 19, and 38–41 under 35 U.S.C. § 103(a) as unpatentable over Lewis
’324, Gerhart, Keller, and Reynolds.

Non-Obviousness over Lewis ’689, Goede, Keller, and Reynolds
The Examiner finds that Lewis ’689 is similar in disclosure to Lewis
’324 and “the only missing element from Lewis [’689] is the amount of
glycopyrronium bromide.” (Ans. 16; Final Action 11.) The Examiner finds
that Goede teaches combining formoterol and glycopyrrolate in treating
chronic obstructive pulmonary disease where those actives may be together
or separately administered and may be in a separate formulation or in a
single formulation and the formulation may be an inhalable solution or
dispersion in a propellant or a nebulizable composition. (Final Action 11–
12.) The Examiner further finds that Goede teaches:
A suitable daily dose of formoterol, or salt or thereof,
particularly as formoterol fumarate dihydrate, for inhalation
may be from 1 to 72 μg (see page 5, lines 34-36). A suitable
daily dose of glycopyrrolate salt, particularly as (R,R)-
glycopyrrolate, for inhalation may be from 5 to 500 μg,
preferably from 15 to 300 pg. A dosage range between 5 and
100 pg/day is especially preferred. The precise doses used will
depend on the condition to be treated, the patient and the
efficiency of the inhalation device (See page 6, lines 3-7).
(Id. at 12 (emphasis in original).) Finally, the Examiner notes that Goede
provides a specific formulation that includes formoterol, glycopyrrolate,
HFA propellant, ethanol, and additives in a suspension. (Id. (referring to
example 2).) The Examiner relies on Keller and Reynolds for the same
reasons as discussed above. (See id. at 12–13.)
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As with the Lewis-Gerhart obviousness rejection discussed above, the
Examiner contends that the claimed concentration ranges would have been
obvious because “the references provide adequate guidance for one of
ordinary skill in the art to deduce the desired, effective and safe amounts of
each component for the said formulations.” (Id. at 14.)
We disagree with the Examiner’s conclusion that one of ordinary skill
in the art would have determined to use an amount of glycopyrronium
bromide within the claimed amount with a reasonable expectation of success
based on the teachings of Goede, Keller, and Reynolds for similar reasons as
discussed above with respect to the Lewis-Gerhart rejection. In particular,
Goede’s Example 2 formulation that includes HFA and ethanol is a
suspension pMDI formulation. (Goede 7.) And, as we discussed above,
Professor Dalby explains that there are different concerns for the
composition of a suspension composition for pMDI than there are for
solution compositions for pMDI. (See, e.g., Dalby Declaration ¶¶ 58, 67–
69.) This provides the backdrop for why he concludes that a person of
ordinary skill in the art would not expect the concentration or amounts of an
active agent used in a suspension composition for pMDI to be the same
amounts for use in a propellant based solution pMDI composition or even
that the amount to be used could reasonably be extrapolated therefrom.
Furthermore, in light of Professor Dalby’s discussion of the unpredictability
of arriving at solution pMDI formulations generally, and particularly where
more than one active ingredient is included (id. ¶¶ 27, 28, 33, 58), we do not
find the broad discussion in Goede of a suitable daily dose of
glycopyrronium bromide to provide guidance to one of ordinary skill in the
art in arriving at the claimed amount of glycopyrronium bromide to be used
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in a solution pMDI formulation described in Lewis ’689 that also includes
formoterol. The Examiner’s position that is contrary to the expert’s again is
conclusory, lacking a reasoned explanation to disregard the expert
testimony. For this reason alone, the preponderance of evidence on this
record fails to support the Examiner’s conclusion of obviousness as to a
composition including the claimed amount of glycopyrronium bromide
dissolved in HFA-134a and ethanol for use with a pressurized metered dose
inhaler.
The Examiner’s rejection regarding the claimed amount of HCl also
suffers from the same infirmities we discussed above with respect to the
Lewis-Gerhart rejection.
We, therefore, reverse the Examiner’s rejection of claims 1, 2, 5–9,
18, 19, and 38–41 under 35 U.S.C. § 103(a) as unpatentable over Lewis
’689, Goede, Keller, and Reynolds.

The Provisional Obviousness-Type Double Patenting Rejection
Appellant does not contest the Examiner’s provisional obviousness-
type double patenting rejection involving Application 14/585,533.
However, as of the writing of this opinion, the co-pending application has
not issued as a patent. Thus, we decline to reach the rejection as the issue is
not ripe for decision. Ex parte Moncla, 95 USPQ2d 1884, 1885 (BPAI
2010) (precedential) (Where the co-pending, reference application has not
issued, it is “premature for the original Board panel to address the
Examiner's provisional rejection of the claims.”); Manual of Patent
Examining Procedure § 804(I)(B) (“The ‘provisional’ double patenting
rejection should continue to be made by the examiner in each application as
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long as there are conflicting claims in more than one application unless that
‘provisional’ double patenting rejection is the only rejection remaining in at
least one of the applications”) (emphasis added)).

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 2, 5–9,
18, 19, 38–
41
103(a) Lewis ’324,
Gerhart, Keller,
Reynolds
1, 2, 5–9,
18, 19, 38–
41
1, 2, 5–9,
18, 19, 38–
41
103(a) Lewis ’689,
Goede, Keller,
Reynolds
1, 2, 5–9,
18, 19, 38–
41
1, 2, 5–9,
18, 19, 38–
41
Provisional
Obviousness-type
Double Patenting6

Overall
Outcome
1, 2, 5–9,
18, 19, 38–
41

REVERSED

6 As explained above, we do not reach this rejection per Ex parte Moncla, 95
USPQ2d 1884, 1885 (BPAI 2010) (precedential).