George Shlieout et al.

Patent Trials and Appeals Board

Apr 2, 2021

2020005326 (P.T.A.B. Apr. 2, 2021)

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.
11/464,704 08/15/2006 George Shlieout 032591-9007-01
(SPH0526)
9044
17567 7590 04/02/2021
(AbbVie)
1 North Waukegan Road
North Chicago, IL 60064
EXAMINER
ROSENTHAL, ANDREW S
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
04/02/2021 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):
abbvie_patents_abt_prk@abbvie.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE SHLIEOUT, CLAUS-JUERGEN KOELLN,
FRITHJOF SCZESNY, JENS ONKEN, and
GUIDO RUESING
Appeal 2020-005326
Application 11/464,704
Technology Center 1600
Before DONALD E. ADAMS, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 77–82 and 84–15 directed to processes
for the manufacture of pancreatin micropellet cores as being obvious. Oral
argument was heard on March 23, 2021. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm. Our affirmance also includes new grounds of rejection.

1 We use the term “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as AbbVie
Pharmaceuticals GmbH. (Appeal Br. 1.)
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STATEMENT OF THE CASE
“Pancreatin is a mixture of different physiologically active
endogenous ingredients which are derived from mammalian pancreas glands
and comprised of several different digestive enzymes such as lipases,
amylases and proteases.” (Spec. 3:9–11.) “Pancreatin for pharmaceutical
use is typically of bovine or porcine origin with porcine pancreatin being
preferred.” (Id. at 3:14–15.)
“Pancreatin microspheres are the treatment of choice for diseases or
disorders caused by digestive enzyme deficiency in mammals such as
humans.” (Id. at 1:13–14.) “This is due to the fact that high-performance
pancreatin microsphere products . . . provide a therapeutically effective load
of active enzymes while at the same time providing properly sized
microspheres capable of targeting the optimal location in the digestive tract
where digestive enzyme activity will be needed, in particular the upper
intestine.” (Id. at 1:14–18.)
According to Appellant’s Specification it “has previously been
understood” with respect to “manufacturing pancreatin micropellet products
by extrusion and subsequent spheronisation of the extrudates” that “synthetic
oils like paraffins, e.g. liquid paraffins (mineral oils)[,] . . . [were] a
necessary excipient.” (Id. at 1:27–30.) Appellant’s invention is directed to
pancreatic micropellets that are enteric coated and are substantially free of
synthetic oils. (Id. at 1:8–11, 2:18–20.)
Claims 77, 82, 112, and 136, reproduced below, are illustrative of the
claimed subject matter:
77. A pharmaceutical composition comprising:
(a) a pancreatin core, wherein the core consists of:
(i) 70% to 90% pancreatin; and
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(ii) 10% to 30% of at least one pharmaceutically acceptable
binding agent, wherein the percentages of components are
weight to weight of the core; and
(b) an enteric coating on the core;
wherein the pancreatin core and the enteric coating are
substantially free of synthetic oils, and wherein at least 55% of
lipase activity in the composition is released within 30 minutes
in a buffer solution at pH 6 as measured according to United
States Pharmacopoeia.
82. A delayed-release oral pharmaceutical composition
comprising:
(a) pancreatin micropellet cores comprising
(i) pancreatin; and
(ii) at least one pharmaceutically acceptable
binding agent,
wherein the cores are substantially free of synthetic oils;
and
(b) an enteric coating on the cores;
wherein the enteric coating is substantially free of
monomeric phthalic acid esters;
wherein the composition has a relative gastric acid
resistance of 75% or more following incubation for 2 hours in a
phosphate buffer solution at pH 5; and
wherein at least 65% of lipase activity in the enteric
coated pancreatin micropellets is released in 30 minutes in a
phosphate buffer solution at pH 6.0 at 37°C, in a dissolution
apparatus, using a paddle speed of 50 rpm, following 2 hours
incubation in a gastric juice without enzymes at 37°C, in a
dissolution apparatus, using a speed of 100 rpm.
112. A delayed-release oral pharmaceutical composition
comprising:
(a) pancreatin micropellet cores comprising
(i) one active pharmaceutical ingredient consisting
essentially of pancreatin and
(ii) at least one pharmaceutically acceptable binding
agent,
wherein the cores contain no more than a
pharmaceutically acceptable trace amount of synthetic oils; and
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(b) an enteric coating on the cores;
wherein the composition has a relative gastric acid
resistance of 75% or more following incubation for 2 hours in a
phosphate buffer solution at pH 5; and
wherein at least 65% of lipase activity in the enteric
coated pancreatin micropellets is released in 30 minutes in a
phosphate buffer solution at pH 6.0 at 37°C, in a dissolution
apparatus, using a paddle speed of 50 rpm, following 2 hours
incubation in a gastric juice without enzymes at 37°C, in a
dissolution apparatus, using a speed of 100 rpm.
136. A delayed-release oral pharmaceutical composition
comprising:
(a) pancreatin micropellet cores consisting essentially of
pancreatin and one or more suitable pharmaceutically
acceptable excipients, wherein at least one excipient is a
pharmaceutically acceptable binding agent; and
(b) an enteric coating on the cores;
wherein the composition has a relative gastric acid
resistance of 75% or more following incubation for 2 hours in a
phosphate buffer solution at pH 5; and
wherein at least 65% of lipase activity in the enteric
coated pancreatin micropellets is released in 30 minutes in a
phosphate buffer solution at pH 6.0 at 37°C, in a dissolution
apparatus, using a paddle speed of 50 rpm, following 2 hours
incubation in a gastric juice without enzymes at 37°C, in a
dissolution apparatus, using a speed of 100 rpm.
(Appeal Br. 36– 45 (V. Claims Appendix (emphasis added).)

REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Sander-Struckmeier US 7122357 B2 Oct. 17, 2006
Maio US 2004/0101562 A1 May 27, 2004

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REJECTIONS
We review the Examiner’s rejection of claims 77–82 and 84–159
under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Sander-
Struckmeier and Maio.
We however also institute the following new grounds of rejection,
discussed in detail below:
Claims 77–82 and 84–159 under 35 U.S.C. § 102(b) as being
anticipated by Maio.
Claims 77–82 and 84–135 as being indefinite under 35 U.S.C.
§ 112, second paragraph.
OPINION
I. Obviousness
The Examiner finds that Sander-Struckmeier teaches forming
microsphere cores of pancreatin and polyethylene glycol with propan-2-ol.
(Final Action 8.) The Examiner further finds that “the mixture is extruded
and rounded using liquid paraffin and propan-2-ol prior to drying” and that
if any of the liquid paraffin, which was added after formation of the core,
remains, it would be about 2% or less of the core material, assuming
complete evaporation of the alcohol. (Id. at 8, 9.) The Examiner concludes
that the 2% or less of the liquid paraffin that might remain in the core
“qualifies as being a ‘trace’ amount or wherein the core is ‘substantially
free’ of said oil.” (Id. at 9.) In addition, the Examiner concludes that
because “Applicant has not provided what the basic and novel characteristics
of ‘consisting essentially of’ exactly are . . . then oils in trace amounts are
permitted to be present in the final composition of claim 136 even though
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synthetic oils are not, per se, a pharmaceutically acceptable excipient as
defined by the Applicant in the specification at (pg 5, lns 18-19).” (Id.)
The Examiner also finds that the core is taught to be enteric coated.
(Id. at 8.) The Examiner acknowledges that Sander-Struckmeier does not
explicitly teach the lipase activity and its release time, but concludes that
because the “prior art teaches the identical chemical structure” claimed, the
properties claimed “are necessarily present. In re Spada, 911 F.2d 705, 709
(Fed. Cir. 1990).” (Id. at 9.)
The Examiner recognizes that “Sander-Struckmeier does not teach an
enteric coating that is substantially free of monomeric phthalic acid esters”
(Id. at 10). This is not a limitation of independent claims 77, 112, and 136.
However, it is a limitation required by independent claim 82, and dependent
claims 109 (depending from independent claim 77), 113 (depending from
independent claim 112), and 137 (depending from independent claim 136)).
The Examiner finds that replacing the enteric coating of Sander-
Struckmeier with one that is substantially free of monomeric phthalic acid
esters would have been obvious in light of the teachings of Maio. (Id.) The
Examiner states that “Maio teaches pancreatin micropellets consisting of
pancreatin and PEG4000 that are formed into spherical granules and coated
with an enteric coating [0052–0053].” (Id.) The Examiner notes that the
enteric coating taught “comprises HP-55 polymer, triethylcitrate, and talc
and is completely free of monomeric phthalic acid esters.” (Id.) The
Examiner concludes that substituting the coating of Maio for the coating of
Sander-Struckmeier would have been obvious because, “[g]enerally, it is
prima facie obvious to substitute one equivalent component or process for
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another, each of which is taught by the prior art to be useful for the same
purpose (see MPEP 2144.06).” (Id.)
Appellant disagrees with the Examiner’s position that about 2% liquid
paraffin in the Sander-Struckmeier cores complies with the requirements of
the independent claims, namely that the core be “substantially free of
synthetic oils” or that it “contain[s] no more than a pharmaceutically
acceptable trace amount of synthetic oils,” or “consist[] essentially of
pancreatin and one or more suitable pharmaceutically acceptable
excipients.” (Appeal Br. 10–12.) According to Appellant these phrases
should be construed as requiring pancreatin core compositions “containing
approximately 0% synthetic oils.” (Appeal Br. 23–25.)
Appellant urges that its claim construction is consistent with the
definition in the Specification as-filed. Appellant states “[t]he specification
‘repeatedly, consistently, and exclusively’ depicts the invention as
eliminating the need for synthetic oils in pancreatin micropellet cores and/or
pancreatin micropellets yet retaining their functions” and that the
“specification has provided ample guidance to enable a person of ordinary
skill to draw a line between synthetic oils being present in small amounts,
e.g., as impurities in the starting materials, versus essential ingredients
intentionally added in the pancreatin formulation. (Id. at 25.) In particular,
Appellant argues that none of the exemplified compositions contain
synthetic oil “as a necessary excipient,” but “the specification recognizes
that the starting materials may contain small amounts of synthetic oils” and
“thus the specification expressly characterizes synthetic oils as
‘pharmaceutically acceptable trace contaminants’” that may be present due
to unavoidable impurities introduced into the formulation by the starting
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materials. (Id. at 25–26.) According to Appellant, “[t]he Examiner’s
position requiring Appellant to specify a particular number as the cutoff
between their invention and the prior art is improper and impractical.” (Id.
at 26.)
Appellant argues that the Examiner’s interpretation that 2% liquid
paraffin of Sander-Struckmeier that was added purposefully during the
process of making the core is inconsistent with the Specification’s definition
of “substantially free of synthetic oils.” (Appeal Br. 16.) Appellant also
argues that the Examiner’s claim interpretation is inconsistent with the
Specification. In particular, Appellant argues that the Specification’s
description of the primary purpose of the invention is “to provide patients
with a pancreatin micropellet product in compliance with the current advice
of the health authorities and which does not include synthetic oils such as
mineral oil” like the prior art compositions of Boedecker/Sander-
Struckmeier. (Appeal Br. 17–18). In addition, Appellant points out that the
Specification describes “how to manufacture an extrudable mixture to form
pancreatin micropellet cores even though the mixture is substantially free of
synthetic oils” (id. at 17), and that all of its exemplified compositions “do
not contain any synthetic oil as an added excipient” (id. at 16).
Furthermore, Appellant argues that the testimony of Dr. Robert
Joseph Kuhn, submitted in the Declaration dated September 16, 2019 (Kuhn
Declaration), supports the conclusion that “one of ordinary skill in the art
would not have considered the claimed pancreatin formulations with ‘no
more than a pharmaceutically acceptable trace amount of synthetic oils’ to
include Sander-Struckmeier’s composition which has about 2% liquid
paraffin in the pancreatin cores.” (Id. at 19–20.) Appellant also argues that
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the Examiner’s conclusion improperly relied on “definitions of trace
amounts from technological areas not remotely related to the claimed
invention to form the claim interpretation.” (Id. at 20–22.)
CLAIM CONSTRUCTION
To resolve the foregoing dispute, we must construe certain claim
terms; namely, the language in independent claims 77 and 82, respectively,
“wherein the pancreatin core . . . [is] substantially free of synthetic oils” and
“wherein the cores are substantially free of synthetic oils,” and in
independent claim 112, “wherein the cores contain no more than a
pharmaceutically acceptable trace amount of synthetic oils.”
We apply the broadest reasonable interpretation standard to claims
that are pending in an application. In this endeavor, to determine the
interpretation that is reasonable in light of the record evidence and the
understanding of one skilled in the art, we “consider the claims in light of
the specification and teachings in the underlying patent.” In re Power
Integration, Inc., 884 F.3d 1370, 1375 (Fed. Cir. 2018) (quoting In re CSB-
Sys. Int’l, Inc., 832 F.3d 1335, 1341 (Fed. Cir. 2016)).
A. “substantially free of synthetic oils”
Appellant’s Specification defines the phrase “substantially free of
synthetic oils” to mean:
that the manufacturing processes described herein and used to
make the pancreatin micropellet cores and/or pancreatin
micropellets do not utilize one or more synthetic oils as an
excipient although synthetic oils may be present as
pharmaceutically acceptable trace contaminants in the
pancreatin, binding agent(s), enteric coating constituents, the
enzyme-friendly organic solvents and/or excipients which are
used to manufacture the pancreatin micropellet cores and/or
pancreatin micropellets described herein.
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(Spec. 4:6–12.) Rather than defining this quantitative term in
measurable amounts, this definition speaks in terms of a processing
activity, standing in stark contrast to the Specification definition of the
phrase “substantially free of enzyme-friendly organic solvents,” which
is defined to be “less than about 5% by weight of the pancreatin
micropellet core.” (Spec. 6:12–14). Nevertheless, “we must respect
this lexicographic choice” to define “substantially free of synthetic
oils” in terms of a specific manufacturing process. Biogen MA, Inc. v
EMD Serono, Inc., 976 F.3d 1326, 1336 (Fed. Cir. 2020); Edwards
Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1329 (Fed. Cir. 2009)
(“[W]e will adopt a definition that is different from the ordinary
meaning when ‘the patentee acted as his own lexicographer and
clearly set forth a definition of the disputed claim term in . . . the
specification’.”).
We note that the processing activity that reflects when the core
is deemed to be substantially free of synthetic oils is “the
manufacturing process described herein,” not any and all
manufacturing processes, contrary to Appellant’s suggestion (Appeal
Br. 16). In this regard, we note the manufacturing process described
in Appellant’s Specification for making “uncoated pancreatin
micropellet cores” that is an alleged “inventive” embodiment involves
mixing pancreatin with PEG 4000 “in a commercially available high
shear mixer and thoroughly moistened with . . . 2-propanolol. (Spec.
13:7–14.) The mixture is then “extruded by means of a commercially
available extruding press” at a “temperature . . . less than 50 ºC while
pressing.” (Id. at 13) The extrudate is cut and placed in “a
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commercially available rounding apparatus and rounded to give
approximately elliptically or approximately spherically shaped
micropellet cores” where additional 2-propanol is added while
rounding. (Id. at 13:13–18.)
We conclude that where a pancreatin core is made by some
other process, Appellant’s definition provided in the Specification is
not applicable.2 In such a case, we are left to ascertain from the
remainder of the Specification what would reasonably be understood
to be within the scope of “substantially free of synthetic oils.” In that
regard, we disagree with Appellant that “containing approximately
0% synthetic oils” (Appeal Br. 23.) is the correct scope of the phrase.
First, that Appellant’s examples of pancreatin cores made by
the disclosed process do not identify any synthetic oils being present
in any amount as an added excipient (Appeal Br. 17) does not require
the upper limit of synthetic oils to be about 0% percent. “While a
court may look to the specification and prosecution history to interpret
what a patentee meant by a word or phrase in a claim, extraneous
limitations cannot be read into the claims from the specification or
prosecution history.” Bayer AG v. Biovail Corp., 279 F.3d 1340,
1348 (Fed. Cir. 2002).

2 We also do not find the Declaration testimony of Mr. Kuhn persuasive on
whether the presence of 2% paraffin would be considered substantially free
of synthetic oils. (Kuhn Declaration ¶ 11.) That is because Mr. Kuhn relies
on the definition in the Specification which as we have discussed is limited
to addition of synthetic oils in the processes disclosed in the Specification
for making pancreatin micropellets.
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We note that nothing in the specific definition or the remaining
description sets an upper quantitative limit for the amount of synthetic
oils in the core to be deemed “substantially free” of synthetic oils.
That is true despite the fact that amounts of liquid paraffin specifically
added during a prior art extrusion process of making pancreatin
micropellets are calculable. (See Kuhn Declaration ¶ 10.)
The Specification explains regarding synthetic oils and the prior
art that
[t]he use of synthetic oils like paraffins, e.g. liquid paraffins
(mineral oils), in particular highly liquid paraffin (light mineral
oil) has previously been understood to be a necessary excipient
for manufacturing pancreatin micropellet products by extrusion
and subsequent spheronisation of the extrudates.
(Spec. 1:27–30.) It is further noted, that governmental health
authorities have recently recommended that “mineral oil not be
provided indiscriminately to either pregnant women or infants.” (Id.
at 1:19–23.)
The Specification does not state what governmental health
authorities recommend regarding amounts of synthetic oils such as
mineral oil that are pharmaceutically acceptable as an excipient.
Instead, it merely states
governmental health authorities have initiated a reassessment of
the compatibility of certain pharmaceutical excipients which
had previously been used in the formulation of pancreatin-
containing products and have provided advice concerning
specific pharmaceutical excipients (see e.g. US Code of Federal
Regulations, 21 CFR §201.302), such as mineral oil. It is
recommended today that mineral oil not be provided
indiscriminately to either pregnant women or infants.
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(Spec. 1:19–26.) We note that 21 C.F.R. § 201.302, which is
concerned with labeling and misbranding, states with regard to studies
about mineral oil use:
studies have indicated that when mineral oil is used orally near
mealtime it interferes with absorption from the digestive tract of
provitamin A and the fat-soluble vitamins A, D, and K, and
consequently interferes with the utilization of calcium and
phosphorus, with the result that the user is left liable to
deficiency diseases. When so used in pregnancy it predisposes
to hemorrhagic disease of the newborn.
21 C.F.R. § 201.302(a). In addition the regulation states:
There is accumulated evidence that the indiscriminate
administration of mineral oil to infants may be followed by
aspiration of the mineral oil and subsequent “lipoid
pneumonia.”
Id. at § 201.302(b). In light of the studies, the regulation provides that
labeling should not encourage use of mineral oil during pregnancy or
administration to infants and it should include a warning against
consumption other than at bedtime and against administration to
infants. Id. at § 201.302(c), (d). However, the regulation does not
state what amount of mineral oil is outside of acceptable limits in
drugs for internal use. Thus, the regulation referred to in the
Specification does not provide any indication of a specific quantitative
amount of a mineral oil that would not be acceptable to include in a
composition intended for pharmaceutical use.3 And we cannot

3 For these reasons, the claim interpretation issue is not analogous to that in
TF3 LTD. v. TreMilano LLC, 894 F.3d 1366 (Fed. Cir. 2018). (See Appeal
Br. 14.) That is we do not have a situation in which the claims were
interpreted by the Examiner “more broadly then the description in the
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conclude from any of this that there is a governmental
recommendation that no amount of mineral oil or other synthetics oils
are pharmaceutically acceptable in a pancreatin composition. That the
FDA may now require a warning with respect to pregnant patients or
infants be provided on formulations that include an amount of mineral
acid, but does not require removal of prior formulations from the
market, does not mean that the amounts of mineral oil present in the
marketed formulations are not pharmaceutically acceptable.
According to Appellant, “it is clear from the as-filed
[S]pecification that the pancreatin micropellets of the claimed
invention were improvements of pancreatin compositions that were
available in the art and contained synthetic oil, specifically the
pancreatin compositions of Boedecker [which are the same as Sander-
Struckmeier].” (Appeal Br. 18.) Even if true, Appellant’s claim
language does not require that synthetic oils be completely absent, just
that it be “substantially free from” such oils. And, even Appellant’s
explicit definition of “substantially free from synthetic oils,” which is
tied to the process of manufacture disclosed in the Specification,
states that synthetic oils “may be present” as pharmaceutically
acceptable trace contaminants, even though synthetic oils “are not to
be regarded as” “suitable pharmaceutically acceptable binding agents”
(Spec. 5:6–7), “suitable pharmaceutically acceptable excipients”
(Spec. 5:8) “suitable enzyme-friendly organic solvents” (Spec. 5:34).
Thus, we do not conclude from Appellant’s Specification that

specification.” (Id. (citing TF3 LTD. v. TreMilano LLC, 894 F.3d at 1372–
73)).
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“substantially free from synthetic oils” means approximately 0%
synthetic oils.
Furthermore, that Appellant intended to pursue patent
protection for a composition that is different from the prior art does
not require that we construe the phrase “substantially free from
synthetic oils” to not include formulations that have 2% mineral acid
associated with the pancreatin core. If such a precise limitation were
desired, Appellant could have drafted a claim reciting “less than about
2% synthetic oils.”
We do not find compelling Appellant’s argument that the
rationale in In re Marosi, 710 F.2d 799 (Fed. Cir. 1983) should apply
to the claim construction at issue here. (Appeal Br. 24–25.) First,
unlike in Marosi, Appellant’s claims are not directed to what was
found surprising to the inventors, i.e., making a pancreatin
composition using an extrusion process where synthetic oils need not
be added to the mixture that is to be extruded or in the rounding of the
cut extrudate. In particular, Appellant’s Specification states:
It has now been surprisingly found that pancreatin micropellet
cores which are suitable for enteric coating, are high in
enzymatic activity and are substantially free of synthetic oils
like paraffins, e.g. highly liquid paraffin, can be produced by
the processes described herein. It has further been found that
the manufacturing process described herein is an improvement
when compared to known processes which use mineral oil or
known processes which would e.g. need more process steps to
produce pancreatin micropellet cores.
(Spec. 3:16–22 (emphases added).) In addition, the Specification
states:
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In one embodiment, the pancreatin micropellet cores are created
in process step b.) by extrusion. Remarkably, an extrudable
mixture is obtained even though the mixture is substantially
free of synthetic oils.
(Spec. 6:24–26.) The Specification continues noting:
[T]hen the extrudate fragments are brought to a suitable length
for the forming step. This can be done e.g. by means of a
cutting device arranged downstream to the extruding press in a
manner known to the a person of ordinary skill in the art. The
forming in process step c.) can be carried out e.g. in a
customary rounding apparatus. In the rounding apparatus, the
extrudate fragments are then formed into an approximately
spherical or approximately ellipsoidal shape in the presence of
additional enzyme-friendly organic solvent which may be the
same or different than the enzyme-friendly organic solvent used
in process step a).
(Spec. 6:33–7:2.) The Specification explains with respect to the
processing in the rounding apparatus that the processing
is improved relative to other known processes. For example, a
lower amount of enzyme-friendly organic solvent needs to be
added when forming the pancreatin micropellet cores into an
approximately spherical or approximately ellipsoidal shape and
fewer of the extrudate fragments stick to parts of the rounding
apparatus when the process is practiced with an extruder and
rounding apparatus.
(Id. at 7:4–9.) The Specification states that “the pancreatin
micropellet cores and the pancreatin micropellets produced according
to the processes disclosed herein and not using synthetic oils
unexpectedly show essentially the same properties as pancreatin
micropellet cores and micropellets produced according to known
processes using mineral oil such as the processes disclosed in U.S.
Patent No. 5,378,462.” (Id. at 7:17–21 (emphasis added).)
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However, the claims on appeal are not directed to a process of
manufacturing a pancreatin micropellet, much less one described in
the Specification, nor is the product claimed directed to a product
made by the disclosed process. Cf. Marosi, 710 F.3d at 800, 802–03
(noting that the claims were directed to a process (or product-by-
process) that did not require use of alkali metal in synthesizing a
particular type of zeolite structure: “[W]e note that appellants’
invention, simply put, is the discovery that zeolites may be
synthesized without the presence in the reaction mixture of alkali
metal.”). Thus, we do not have claims requiring “the practical
elimination” of an essential ingredient. Id. As such, and unlike the
claims presented in In re Marosi, whether or not a person could “draw
a line between unavoidable impurities in starting materials and
essential ingredients” in a manufacturing process to make pancreatin
cores or compositions does not control the claim interpretation here.
Marosi, 710 F.2d at 803.
We do note, however, the Specification provides some
indication that the phrase “substantially free” with respect to amounts
by weight of a composition can include amounts in excess of 2%. In
particular, as we noted above, the Specification defines the term
“substantially free of enzyme-friendly organic solvents” to “mean[]
that the quantity of enzyme-friendly organic solvents present in the
pancreatin micropellet cores would be less than about 5% by weight
of the pancreatin micropellet core.” (Spec. 6:12–14.)
We conclude that a composition that includes 2% by weight of
synthetic oils may be deemed to be “substantially free of synthetic
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oils” provided that the remaining limitations of the claim are met.
Thus, with respect to claim 77, if a composition had a pancreatin core
that only “consists of” pancreatin4 and pharmaceutically acceptable
binding agents (which Appellant’s Specification defines synthetic oils
to not be (Spec. 5)), then we would find such a composition to be
substantially free of synthetic oils.
And with respect to claim 82, if a composition had a pancreatin
core that “comprises” pancreatin and pharmaceutically acceptable
binding agents and synthetic oils are present, then we would find such
a composition to be substantially free of synthetic oils.
B. “contain[s] no more than a pharmaceutically acceptable trace
amount of synthetic oils”
Appellant contends that this phrase is interchangeable with
substantially free of synthetic oil and should be interpreted to mean
approximately 0% of synthetic oils for the same reasons. (Appeal Br.
23 n. 6.) While we agree with Appellant that the phrases can have the
same meaning, just as we do not find support in the Specification for
construing substantially free as meaning approximately 0% of
synthetic oils, we do not find support in the Specification for
construing the trace amount phrase in this way. The Specification
does not define the phrase “pharmaceutically acceptable trace
amount.” And as discussed above, we do not find the reference to
regulatory reassessment of labeling drugs with mineral oil as an

4 Appellant’s Specification teaches that pancreatin “is a mixture of different
physiologically active endogenous ingredients which are derived from
mammalian pancreas glands.” (Spec. 3.)
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excipient to provide an indication that mineral oils should be present
in pancreatin products at close to 0%.
Appellant further points to the Declaration testimony of
Mr. Kuhn to argue that “one of ordinary skill in the art would not
consider 2% paraffin, as described in Sander-Struckmeier, as a
pharmaceutically acceptable trace amount of synthetic oil, nor would
it be a suitable pharmaceutically acceptable excipient.” (Appeal Br.
20.)
In arriving at his conclusion, Mr. Kuhn contends that 2%
paraffin would not be considered to be such an amount in light of the
fact that Appellant’s Specification “indicates the certain excipients
that have been used in the formulation of pancreatin containing
products, such as mineral oil, should be reassessed. (Specification at
para. 4.).” (Kuhn Declaration ¶ 12.) Mr. Kuhn also considered that
EPI treatment requires chronic intake of pancreatin products, and 2%
of paraffin in a product “would cause cumulative toxicity that would
not be pharmaceutically acceptable” given patients who suffer EPI
from birth, and take pancreatin products “three to five times a day,
two or more capsules each time in order to receive nourishment from
their food.” (Kuhn Declaration ¶ 13.) Mr. Kuhn states: “In view of
the context of this chronic application, small amounts of synthetic oil
administered over a long period of time would not be
pharmaceutically acceptable.” (Id.)
We do not find Mr. Kuhn’s testimony persuasive because, as
discussed above, Appellant’s Specification does not indicate any
particular level of mineral oil that must be avoided generally, or by
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pregnant women specifically. And as we discussed above, the FDA
regulation referenced does not provide such information either.
Moreover, Appellant’s Specification does not state that the prior art
formulations that include mineral oils have been required to be
removed from the market. Thus, Mr. Kuhn’s conclusion as to why
2% mineral oil would not be considered a pharmaceutically
acceptable trace amount is unsupported by an evidentiary foundation
and we decline to give it persuasive weight. See Perreira v. Secretary
of the Dept. of HHS, 33 F.3d 1375, 1377 (Fed. Cir. 1994) (“An expert
opinion is no better than the soundness of the reasons supporting it.”);
In re Beattie, 974 F.2d 1309, 1313 (Fed. Cir. 1992) (opinion evidence
in declarations has little value without factual support); Velander v.
Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (“The Board has broad
discretion as to the weight to give to declarations offered in the course
of prosecution.”).
In light of the fact that there is no evidence indicating prior art
pancreatin products having mineral oil in measurable quantities have
been required to be withdrawn from the market, we conclude that the
phrase “pharmaceutically acceptable trace amount” includes amounts
of mineral oil that were extant in commercially available prior art
pancreatin compositions.

Does the Sander-Struckmeier Pancreatin Core Read on the Claimed
Pancreatin Core?
The Examiner and Appellant are in agreement that Sander-
Struckmeier teaches inclusion of about 2% liquid paraffin (mineral
oil) in the preparation of the pancreatin core. The Examiner contends
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that this 2% meets the substantially free of, or trace amount
requirements of claims 77, 82, and 112. (Final Action 9.) And the
Examiner contends that because Appellant has not provided what the
basic and novel characteristics of the pancreatin core is, and the
pharmaceutical composition claimed by Appellant in claim 136 is said
to comprise the core and enteric coating on the core, the oil added
during spherical shaping that may remain on the core that is dried and
in the final composition that is enterically coated of Sander-
Struckmeier meets the limitations of claim 136. (Final Action 9.)
Appellant argues that because the paraffin is intentionally added
as an excipient in Sander-Struckmeier and “is present in the
formulation in an amount that is required to perform its intended
function,” it is erroneous to consider the core of Sander-Struckmeier
to meet the limitations of claims 77, 82, 112, and 136. (Appeal Br.
18, 19, 11–12.)
A. Claim 77
We think the Appellant has the better argument with respect to
claim 77. “[C]losed transition phrases such as ‘consisting of’ are
understood to exclude any elements, steps, or ingredients not specified
in the claim.” AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239,
1245 (Fed. Cir. 2001).
The claim requires that the pancreatin core “consists of”
pancreatin and at least one pharmaceutically acceptable binding agent
and the Specification states that the mineral oils are not to be
considered as such a binding agent. We do not find that the paraffin
oil (“liquid paraffin”) in Sander-Struckmeier is added as a binding
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agent. That is because it is added after the core is extruded and cut,
but before rounding, as an aid in spheronization. (Sander-Struckmeier
10:39–51.) Consequently, we do not agree with the Examiner that
Sander-Struckmeier discloses the pancreatin core of claim 77.
B. Claim 82
We think the Examiner has the better argument with respect to
claim 82 because that claim indicates the pancreatin core is one
“comprising” pancreatin and at least one pharmaceutically acceptable
binding agent. “‘Comprising’ is a term of art used in claim language
which means that the named elements are essential, but other elements
may be added and still form a construct within the scope of the
claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir.
1997). Thus, here, the core is permitted to include other elements
besides pancreatin and binding agents, and as noted above, the liquid
paraffin is added after the core is extruded and cut, but before
rounding, as an aid in spheronization (Sander-Struckmeier 10:39–51).
Thus, the liquid paraffin is not provided to the core as a binding agent.
Although claim 82 also requires that the core be “substantially
free of synthetic oils,” for the reasons discussed above in the claim
construction, we conclude that having 2% paraffin oil is within the
scope of that limitation. The fact that the paraffin oil is intentionally
added during the process of rounding the compressed extrudated core
material does not require a different conclusion. The intent for which
an ingredient is added to a composition does not change its character
as an ingredient in the composition as claimed. “[A] claimed product
shown to be present in the prior art cannot be rendered patentable
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solely by the addition of source or process limitations.” Amgen, Inc.
v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 n.20 (Fed. Cir.
2003).
C. Claim 112
As with claim 82, we find the Examiner has the better argument
with respect to claim 112. Like claim 82, claim 112 recites the
“pancreatin micropellet cores comprising,” which allows for other
elements besides those recited to be added and still form a construct
within the scope of the claim. Genentech, 112 F.3d at 501.
Moreover, for the reasons discussed above in the claim construction
section, we conclude that having 2% paraffin oil is within the scope of
“no more than a pharmaceutically acceptable trace amount,” even
though mineral oil is intentionally added during the process of
rounding the compressed extrudated core material.
D. Claim 136
We also find the Examiner has the better argument with respect
to claim 136. Use of “consisting essentially of” language “opens the
claims to the inclusion of ingredients which would not materially
affect the basic and novel characteristics of appellant’s compositions
as defined in the balance of the claim.” In re Janakirama-Rao, 317
F.2d 951, 954 (CCPA 1963). According to Appellant, the basic and
novel characteristic of the composition is that it be substantially free
of synthetic oil and yet retain the therapeutic effectiveness. (Appeal
Br. 12 n 2.) Not having a particular ingredient is not an appropriate
“characteristic” in the consisting essentially of assessment. Id. at
953–954 (“Certainly no characteristics whatever are set forth in the
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claims, unless it be in the word ‘optical,’ which modifies ‘glass. . . .
But no basic or novel characteristic to be so affected can be deduced
from the disclosure and none was shown in brief or argument. We
therefore find that the board was correct in holding that there is no
showing of properties patentably distinguishing appellant’s claimed
glasses from those of the reference.’”). The question is whether the
2% synthetic oil amount which becomes part of the Sander-
Struckmeier pancreatin core on rounding of the extrudate materially
affects the fundamental character, i.e. properties, of that pancreatin
core. Appellant’s evidence demonstrating that the core can be
adequately enterically coated with or without synthetic oils present
and the core is therapeutically active with or without the synthetic oils
present (Appeal Br. 27, 29, 31) seems to us to be compelling evidence
that the fundamental character of the pancreatin core is not altered by
the presence of 2% synthetic oil being present on the spheronized core
in the Sander-Struckmeier example.

Unexpected Results
As noted above, the Examiner’s position with respect to obviousness
is only relevant to those claims that recite enteric coatings that are
substantially free of monomeric phthalic acid esters because that is the
limitation that the Examiner asserts is not disclosed by Sander-Struckmeier.
This is a limitation required by independent claim 82, dependent claims 109
(depending from independent claim 77), 113 (depending from independent
claim 112), and 137 (depending from independent claim 136)). It is not a
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limitation of independent claims 112, and 136. Thus, we understand the
Examiner’s rejection of claims 77, 112, and 136 to be one of anticipation.
As we noted above, we do not agree with the Examiner that Sander-
Struckmeier discloses a composition that meets the limitations of claim 77.
However, such is not true with respect to claims 112 and 136. Appellant’s
reliance on unexpected results to establish patentability of these claims that
are anticipated by Sander-Struckmeier is not persuasive. Evidence of
secondary considerations, such as unexpected results, cannot overcome a
rejection based on anticipation. In re Wiggins, 488 F.2d 538, 543 (CCPA
1973). Consequently, we need not consider Appellant’s arguments
regarding unexpected results as to claims 112 and 136. “It is well settled
that ‘anticipation is the epitome of obviousness.’” In re McDaniel, 293 F.3d
1379, 1385 (Fed. Cir. 2002) (quoting Connell v. Sears, Roebuck & Co., 722
F.2d 1542, 1548 (Fed. Cir. 1983)). And thus, we affirm the Examiner’s
rejection of claims 112 and 136 as being anticipated by Sander-Struckmeier.
Regarding claim 82, we note that Appellant’s argument with respect
to unexpected results is directed to the absence of synthetic oils, not to the
elements of the enteric coating, much less that of it being free of monomeric
phthalic acid esters. (Appeal Br. 29, Kuhn Declaration ¶ 20.) However, as
we noted above claim 82 does not require about 0% synthetic oils. This is
true with respect to claims 113 and 137, as well. Consequently, we do not
find Appellant’s evidence of unexpected results to establish non-obviousness
over Sander-Struckmeier and Maio persuasive. Thus, we affirm the
Examiner’s rejection of claims 82, 113, and 137 as being obvious from
Sander-Struckmeier and Maio.
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Appellant does not separately argue the dependent claims. Thus, we
affirm the Examiner’s rejections as to the obviousness over Sander-
Struckmeier and Maio of claims dependent from claims 82, 112, and 136
and not already discussed. 37 C.F.R. § 41.37(c)(1)(iv).

II. Anticipation by Maio
The Examiner identified paragraphs 52 and 53 as being relevant to the
claims on appeal. We agree but note that Maio is more relevant to the
claims on appeal than merely for what the Examiner cited the reference as
teaching.
In particular, Maio’s paragraph 52 teaches pancreatin pellets that were
made by direct spheronization of pancreatin and PEG4000. Paragraph 53
explains that those spherical pellets are coated with HP-55, triethylcitrate
and talc, which is an enteric coating. Maio’s process described in
paragraphs 52 and 53 for creating the pancreatin micropellets and providing
an enteric coating thereon does not use mineral oils.
Appellant’s Specification states that it was remarkable that an
“extrudable mixture is obtained even though the mixture is substantially free
of synthetic oils.” (Spec. 6:25–26.) However, Appellant’s claims are
directed to compositions not the method by which they are made. And,
Maio teaches pancreatin - PEG 4000 pellet compositions that are
subsequently enterically coated and are made without the use of synthetic
oils. Thus, the Maio composition also meets the “substantially free of
synthetic oils” limitations of claims 77 and 82, as well as meeting the “cores
contain no more than a pharmaceutically acceptable trace amount of
synthetic oils” of claim 112, and pancreatin micropellet cores consisting
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essentially of pancreatin and one or more suitable pharmaceutically
acceptable excipients” of claim 136. In light of this, the claimed
composition has not been shown to be “remarkable” over the prior art.
As the Examiner indicated in the statement of rejection (Final Action
9), where the chemical composition claimed is taught by the prior art, one of
ordinary skill in the art has reason to conclude that the properties recited by
the claim are also necessarily achieved. In re Spada, 911 F.2d 705, 709
(Fed. Cir. 1990) (“When the claimed compositions are not novel they are not
rendered patentable by recitation of properties, whether or not these
properties are shown or suggested in the prior art.”); In re Best, 562 F.2d
1252, 1254 (CCPA 1977) (“‘[I]t is elementary that the mere recitation of a
newly discovered function or property, inherently possessed by things in the
prior art, does not cause a claim drawn to those things to distinguish over the
prior art.”).
We conclude that the enterically coated pancreatin pellets taught in
Maio’s example 4 anticipate the compositional elements required by claims
77, 82, 112, and 136, and that they necessarily have the release
characteristics claimed. This rejection applies to the dependent claims on
appeal as well given that Maio teaches these pellets are microspheres. (Maio
¶ 42)
Although Maio, and the primary paragraphs we rely on now, were
before Appellant during prosecution, the thrust of the Examiner’s rejection is
different from what we set forth now. Thus, we designate this rejection as a
new ground of rejection.

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III. Indefiniteness
A claim is properly rejected as indefinite under 35 U.S.C. § 112,
second paragraph, if, after applying the broadest reasonable interpretation in
light of the specification, the metes and bounds of a claim are not clear
because the claim “contains words or phrases whose meaning is unclear.” In
re Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir. 2014) (per curiam)
(approving, for pre-issuance claims, the standard from MPEP §
2173.05(e)); see also Ex parte McAward, Appeal 2015-006416, 2017 WL
3669566, at *5 (PTAB Aug. 25, 2017) (precedential)(adopting the approach
for assessing indefiniteness approved by the Federal Circuit in Packard).
Further, claims, when read in light of the specification, must “reasonably
apprise those skilled in the art both of the utilization and scope of the
invention” using language “as precise as the subject matter
permits.” Packard, 751 F.3d at 1313.
As discussed in the claim construction section above, Claim 112
recites that the cores contain “no more than a pharmaceutically acceptable
trace amount of synthetic oils.” We determine that it is not reasonably
possible to interpret this claim and dependent claims thereon with sufficient
clarity to satisfy 35 U.S.C. § 112, second paragraph. See In re Packard, 751
F.3d 1307, 1313 (Fed. Cir. 2014) (per curiam). Appellant’s arguments on
appeal suggest that there is no universality regarding synthetic oils as to
what is pharmaceutically acceptable, whether that be with respect to time or
geographic location. The Specification does not provide a standard by
which one is to determine pharmaceutical acceptance. Accordingly, we
enter a new ground of rejection as to claim 112 and claims dependent
thereon. Moreover, to the extent that Appellant has argued substantially free
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of synthetic oils is equivalent to the meaning of pharmaceutically acceptable
trace amount of synthetic oils (Appeal Br. 12, n. 3), we enter a new ground
of rejection as to claims 77 and 82 and claims dependent thereon.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed New
Grounds
77–82,
84–159
103 Sander-
Struckmeier, Maio
78–82,
84–103,
106, 107,
112–159
77–81,
104, 105,
108, 109,
110, 111

77–82,
84–159
102 Maio 77–82,
84–159
77–82,
84–135
112,
second
paragraph
77–82,
84–135
Overall
Outcome
78–82,
84–103,
106, 107,
112–159
77–82,
84–159

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
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(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
Affirmed; 37 C.F.R. 41.50(b)