Hans Bär et al.

Patent Trials and Appeals Board

Jul 9, 2020

2019005867 (P.T.A.B. Jul. 9, 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.
13/120,112 06/06/2011 Hans Bär 376169US99PCT 7130
22850 7590 07/09/2020
OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314
EXAMINER
MATTISON, LORI K
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
07/09/2020 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 HANS BÄR, THOMAS FÜRST,
GERHARD RENNER, and MICHAEL GOTTSCHALK
____________

Appeal 2019-005867
Application 13/120,112
Technology Center 1600
____________

BEFORE DONALD E. ADAMS, ERIC B. GRIMES, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from Examiner’s
decision to reject claims 1, 3, 7–12, 14–21, and 24–27 (Final Act.1 2).2 We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Examiner’s Final Office Action mailed October 5, 2018, hereinafter “Final
Act.”
2 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies “EVONIK ROEHM GmbH.” as the real
party in interest (Appellant’s February 12, 2019 Appeal Brief (Appeal Br.)
1).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to a pH-dependent controlled release
pharmaceutical composition for drugs that are not opioids with decreased
susceptibility to the influence of ethanol on the release of active compound”
(Spec. 1:6–8). Appellant’s independent claim 1 is reproduced below:
1. A pH-dependent controlled release pharmaceutical
composition, comprising:
a core comprising at least one pharmaceutically active
ingredient, with the exception of opioids,
wherein the core is coated by 30 to 200 wt.%, calculated
based on the weight of the core, of at least one coating layer
controlling the release of the pharmaceutical composition,
the at least one coating layer comprises
(A) a polymer mixture of
i) 40 – 95 % by weight, based on dry weight of the
polymer mixture, of at least one water insoluble
essentially neutral vinyl polymer or copolymer,
and
ii) 5 – 60 % by weight, based on dry weight of the
polymer mixture, of at least one anionic polymer
or copolymer, which is insoluble in a buffered
medium below pH 4.0 and soluble at least in the
range from pH 7.0 to pH 8.0,
(B) 140 to 250 % by weight of a non-porous inert
lubricant,
(C) 1 to 35 % by weight of at least one neutral cellulosic
compound, and
(D) 1 to 25 % by weight of at least one emulsifier, and
wherein (B), (C), and (D) are each calculated on dry
weight of the polymer mixture,
and
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wherein, under in-vitro conditions according to USP
paddle, 100 rpm, buffered at pH 6.8 in a medium with and
without an addition of 40 % (v/v) ethanol, the controlled release
pharmaceutical composition has:
when the pharmaceutical active ingredient is released to a
degree of less than 20 % without the addition of 40 % (v/v)
ethanol, a difference in the release rate with the addition of
40 % (v/v) ethanol is not more than plus or minus 15 % of a
corresponding release value without 40 % (v/v) ethanol, and
when the pharmaceutical active ingredient is released to a
degree of 20 – 80 % without the addition of 40 % (v/v) ethanol,
the difference in the release rate with the addition of 40 % (v/v)
ethanol is not more than plus or minus 30 % of the
corresponding release value without 40 % (v/v) ethanol,
wherein the water insoluble essentially neutral vinyl
polymer or copolymer is a copolymer comprising at least one
free-radical polymerized unit of
more than 95 up to 100 % by weight of at least one C1- to
C4-alkyl ester of acrylic or of methacrylic acid, and
less than 5% by weight of acrylic or methacrylic acid,
and
wherein said composition excludes the presence of water
insoluble (meth)acrylic polymers composed of 5 or 10 % by
weight of monomer residues containing cationic quaternary
ammonium groups.
(Appeal Br. 50–51 (Claims App.).)

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Grounds of rejection before this Panel for review:3,4
Claims 1, 3, 7–12, 14–21, and 24–27 stand rejected under 35 U.S.C.
§ 112, second paragraph.
Claims 1, 3, 7–12, 14–21, and 24–27 stand rejected under the written
description provision of 35 U.S.C. § 112, first paragraph.
Claims 1, 3, 7–12, 14–21, and 24–27 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Meier,5 Tomuta,6 and
Eudragit.7
Claims 1, 3, 7–12, 14–21, and 24–27 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Meier, Tomuta, Eudragit,
and Matthews.8,9

3 Because it is a petitionable rather than appealable issue, we decline to
address Examiner’s objection to Appellant’s claim 16 (Final Act. 2; see also
cf. MPEP § 2163.06).
4 Examiner’s rejections under 35 U.S.C. § 112, first and second paragraphs,
include canceled claims 2, 4, 6, 9, 22, and 23 (see Final Act. 3 and 9; see
also Examiner’s June 25, 2019 Answer (Ans.) 3, 7; cf. Final Act. 2
(Examiner finds that Appellant canceled claims 2, 4–6, 13, 22, and 23)). We
did not include these canceled claims in our deliberations.
5 Meier et al., US 2008/0193522 A1, published Aug. 14, 2008.
6 Tomuta et al., The Influence of “Formulation Factors on the Kinetic
Release of Metoprolol Tartrate from Prolong Release Coated Minitablets,
33 Drug Development and Industrial Pharmacy 1070–77 (2007).
7 Eudragit Industries AG, EUDRAGIT® NE 40 D, Technical Information
Sheet, INFO 7.11/E, 1–5 (2012).
8 Matthews et al., WO 2007/147438 A2, published Dec. 27, 2007.
9 Eudragit was not included in Examiner’s statement of this rejection (see
Final Act. 20; see also Ans. 15). Examiner’s statement of this rejection,
however, makes reference to the preceding rejection over the combination of
Meier, Tomuta, and Eudragit (Final Act. 20; see also Ans. 15). In addition,
Appellant includes Eudragit as part of this rejection (see Appeal Br. 40; see
also Reply Br. 14). Therefore, we find Examiner’s failure to include
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DEFINITENESS:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that Appellant’s claimed invention is indefinite?
ANALYSIS
Examiner finds that Appellant’s claims 1, 21, 24, and 26 “do not
provide a discernable boundary” as to what structural feature(s) of the
claimed composition provide for “ethanol resistance,” “the storage stability,”
and “gastric resistance” (Final Act. 9–11; see also Ans. 7–9; and Appeal Br.
24).10 We are not persuaded. See Hybritech Inc. v. Monoclonal Antibodies,
Inc., 802 F.2d 1367, 1385 (Fed. Cir. 1986) (Claims comply with the second
paragraph of 35 U.S.C. § 112 if “the claims, read in light of the
specification, reasonably apprise those skilled in the art both of the

Eudragit in the statement of this rejection represents a harmless
typographical error.
10 According to Appellant:
Examiner concludes that the full scope of the claimed
pharmaceutical compositions is not readily discernible without
predetermining what specific kinds, amounts, and relative
amounts of components generally defined and combined in the
claims yields a pharmaceutical composition having the recited
release profile in the absence and presence of ethanol (Claims 1
and 26) and storage stability (Claim 24).
(See Appeal Br. 24, 28 (Appellant contends that Examiner concluded “that
‘the claims do not provide a discernable boundary on what structurally
within the compositions yields the recited release profile in the absence and
presence of ethanol (i.e. ethanol resistance)’” and “Examiner repeats the
same conclusion with regard to both storage stability and gastric
resistance.”).)
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utilization and scope of the invention, and if the language is as precise as the
subject matter permits.”).
Notwithstanding Examiner’s assertion to the contrary, the claims on
this record identify the ingredients, amounts, and location of the ingredients
that result in the claimed compositions’ functional characteristics (see
Appeal Br. 50–51). In this regard, we note that although Appellant’s claims
are broad, “breadth is not to be equated with indefiniteness.” In re Miller,
441 F.2d 689, 693 (CCPA 1971).
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner’s conclusion that Appellant’s claimed invention is indefinite. The
rejection of claims 1, 3, 7–12, 14–21, and 24–27 under 35 U.S.C. § 112,
second paragraph, is reversed.

WRITTEN DESCRIPTION:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention?
ANALYSIS
Although, as discussed above, Appellant’s Specification and claims
identify the ingredients, amounts, and location of the ingredients that result
in the functional characteristics of Appellant’s claimed compositions,

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Examiner finds that Appellant’s claims lack written descriptive support
because
[t]he table on page 40 of [Appellant’s] [S]pecification teaches
two species of pharmaceutical composition having the recited
release characteristics in the presence and absence of ethanol.
These two species differ only in the amount of (C) neutral
cellulosic compound. These two species comprise a coating
comprising (A) a polymer mixture of 85 wt. % Eudragit NE
(A)(i) and 15 wt. % Eudragit FS (A)(ii), (B) 200 wt. % talc, and
(D) 10 wt. % Tween 80. The first species comprised (C) 20
wt.% HPMC while the second species comprised 10 wt.%
HPMC.
(Final Act. 4; see also id. 6–7 (Examiner makes similar findings with respect
Appellant’s claims 21 and 26, which require that the composition exhibits
reduced, or is resistant to, gastric release, respectively); id. at 7 (Examiner
also finds that the table on page 40 of Appellant’s Specification does not
exemplify a composition having a coating thickness less than 49.5 wt. % that
is resistance to a gastric release); cf. Appeal Br. 17 (Appellant asserts that its
“Specification expressly describes each and every limitation of the claimed
pharmaceutical compositions”); see generally Appeal Br. 17–21 (directing
attention to portions of Appellant’s Specification wherein support for the
claimed invention may be found)).
We are not persuaded that Appellant’s claims lack written descriptive
support on this record. “[T]he test for sufficiency [of the written
description] is whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date.” Ariad
Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc). In addition, it is Examiner who “has the initial burden of presenting
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evidence or reasons why persons skilled in the art would not recognize in the
disclosure a description of the invention defined by the claims.” In re
Wertheim, 541 F.2d 257, 263 (CCPA 1976).
On this record, rather than presenting evidence or reasons why those
of ordinary skill in this art would not recognize that Appellant provided
adequate written descriptive support for its claimed invention, Examiner
questions whether Appellant provided a sufficient number of examples (see
Final Act. 4–7; cf. Appeal Br. 16–17, 21 (Appellant contends that “Examiner
objects that Applicant has not provided sufficient examples.”)). As
Appellant explains, however, “[i]t is well established that working examples
are not required to satisfy the requirements of 35 U.S.C. § 112, first
paragraph” (Appeal Br. 16 (citing In re Borkowski, 422 F.2d 904, 908
(CCPA 1970))).
In sum, we find that Examiner failed to establish an evidentiary basis
to support the written description rejection on this record.
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention. The rejection of claims 1, 3,
7–12, 14–21, and 24–27 under the written description provision of 35 U.S.C.
§ 112, first paragraph, is reversed.

OBVIOUSNESS:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
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FACTUAL FINDINGS (FF)
FF 1. Meier “relates to the use of polymer mixtures for the production of
coated pharmaceutical forms, and to a pharmaceutical form with mixed
polymeric coatings” (Meier ¶ 1; see generally Ans. 9 (Examiner finds that
Meier discloses “a coating composition to modify the release of an active
agent (i.e. making the release of the active agent more slow) without
modifying the pH in which the drug release starts (i.e. a pH-dependent
controlled coating which controls drug release).”)).
FF 2. Meier discloses
the use of a mixture of 2 to 60% by weight of one or more
polymers (I) with 40 to 98% by weight of one or more
polymers (II), where
polymer (I) is a (meth)acrylate copolymer comprising 90
to 100% by weight free radically polymerized units of 40 to
95% by weight of C1- to C4-alkyl esters of acrylic or of
methacrylic acid and 5 to 60% by weight units of (meth)
acrylate monomers having an anionic group, and 0 to 10% by
weight of further vinylically polymerizable monomers, and
polymer (II) is a vinyl polymer different from polymer (I)
or a polysaccharide or a derivative of a polysaccharide
comprising 88 to 100% neutral monomer units and up to 12%
by weight polymerized monomer units having ionic radicals,
for the production of a coated pharmaceutical form
comprising an active ingredient-containing core and a
polymeric coating of the mixture of polymers (I) and (II)
characterized in that
the glass transition temperature of polymer (I) is not
more than 70° C., and an active ingredient release profile in
which the active ingredient is released by comparison with a
pharmaceutical form coated with polymer (I) alone starting at
the same pH but more slowly is attained.
(Meier ¶¶ 23–29.)
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FF 3. Meier discloses that “[a] person skilled in the art is able, starting
from active ingredient release characteristics, soluble in intestinal juice, of
anionic or carboxyl group-containing polymers with assigned specific
dissolution pH values to adjust the time course of the active ingredient
release characteristics via the mixing ratio of the polymers” (Meier ¶ 31).
FF 4. Meier discloses that “the degree of release [of active agent from a
coated pharmaceutical dosage form] is always . . . influenced by the layer
thickness of the coating” in addition to the mixing ratio of the polymers, and,
thus, by increasing or reducing the coating layer thickness and using an
appropriate polymer preset mixing ratio, a person of ordinary skill in this art
can control the release of an active agent to a desired range11 (see Meier
¶¶ 39, 150 (Meier discloses that “[t]he degree of release is moreover always
also influenced by the layer thickness of the coating. This can be increased
or reduced with the preset mixing ratio in order to control the release into the
desired range.”), (Meier discloses that the “polymer coating may preferably
for example amount to 2 to 20% by weight in relation to the weight of the
active ingredient-containing core.”); see also Ans. 10).
FF 5. Meier discloses that
It is possible to apply between active ingredient containing
layer and copolymer layer according to the invention a
separating layer which serves to separate active ingredient and
coating material for the purpose of preventing interactions.
This layer may consist of inert film formers (e.g. HPMC, HPC
or (meth)acrylic acid copolymers) or, for example, talc or other

11 Examiner finds that Meier’s “‘mixing ratio’ refers to the mixing of ratios
of Polymer (I) to Polymer (II)” (Ans. 22 (citing Meier ¶¶ 36–38)).
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suitable pharmaceutical substances. It is likewise possible to
use combinations of film formers and talc or similar substances.
(Meier ¶ 116; see Ans. 10 and 12.)
FF 6. Meier discloses that “[i]t is also possible to apply an outer covering
layer (topcoat) of a further, preferably water-soluble, polymer and
excipients, e.g. pigments and/or mold release agents, which ensures further
functions such as, for example, coloring or prevention of adhesion” (Meier
¶¶ 152, 176 (Meier discloses that “[m]old release agents[, such as
talc,] prevent agglomeration of the cores during the film coating,” wherein
“[t]he usual amounts employed of mold release agents in the coating agents
and binders according to the invention are between 0.5 to 100% by weight
based on the dry weight of the dispersion.”); see also Ans. 10).
FF 7. Meier discloses that its pharmaceutical dosage form is suitable for a
number of active ingredients, including metoprolol (see Meier ¶ 199; see
also Ans. 12–13).
FF 8. Examiner finds that Meier “does not teach a formulation comprising
a coating layer that comprises 1-35% [of] at least one neutral cellulosic
compound, which is [HPMC]” (Ans. 13).
FF 9. Tomuta studied the “influence of the amount of polymer film
formatting (Eudragit NE 40D) and the amount of pore generating excipient
in polymeric insoluble film (low viscosity hydroxypropyl methylcellulose-
Methocel E 15LV) on the in vitro drug release profile” of metoprolol tartrate
minitablet dosage forms with the aim of obtaining “an oral extended-release
dosage form[] with zero order kinetic release” profile (Tomuta, Abstract);
see id. at 1070 (Tomuta discloses that “[t]he ideal release of drug from the
oral extended release dosage form is the zero order profile,” wherein “drug
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is released from the dosage form at the same slow rate throughout the entire
release period”); see also Ans. 13–14).
FF 10. Tomuta discloses that “Eudragit NE 40D is an aqueous dispersion of
a neutral copolymer based on ethyl acrylate and methyl methacrylate”
(Tomuta 1074; see also Ans. 13).
FF 11. Examiner finds that Tomuta discloses “a coating comprising 16%
HPMC by weight of Eudragit NE 40D polymer” that “had the lowest amount
of HPMC pore-former excipient and highest amount of insoluble Eudragit
NE 40D polymer” (Ans. 13–14 (citing Tomuta 1071: Table 2)).
FF 12. Examiner relies on Eudragit to disclose that
“[t]he polymer contained in EUDRAGIT NE 40 D is identical
to the polymer in EUDRAGIT NE 30 D”; thereby, EUDRAGIT
NE 40 is implicitly taught to be a water-insoluble neutral vinyl
polymer which comprises more than 95-100% by weight of at
least on[e] C1-C4 alkyl ester of acrylic or methacrylic acid and
less than 5% by weight of acrylic or methacrylic acid.
(Ans. 13 (citing Eudragit 1).)
FF 13. Examiner finds that the combination of Meier, Tomuta, and Eudragit
fails to teach an “inert lubricant . . . in an amount of 140-220% by weight
calculated on dry weight of the polymer mixture” (Ans. 16).
FF 14. Matthews relates “to a sequestering subunit comprising an antagonist
and a blocking agent, and related compositions and methods of use, such as
in the prevention of abuse of a therapeutic agent” (Matthews 1:6–8; see also
Ans. 16 (Examiner finds that Matthews discloses “a pharmaceutical
composition in which a therapeutic agent and its antagonist are administered
together”)).

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FF 15. Matthews discloses
that the first antagonist-impermeable material comprises a
polymer insoluble in the gastrointestinal tract. One of ordinary
skill in the art appreciates that a polymer that is insoluble in the
gastrointestinal tract will prevent the release of the antagonist
upon ingestion of the sequestering subunit. The polymer may
be a cellulose or an acrylic polymer.
(Matthews 16:14–18; see also Ans. 16 (Examiner finds that Matthews
discloses that “the therapeutic agent in his invention may be in sustained
release form”).)
FF 16. Matthews discloses that the acrylic polymer may be an acrylic resin
sold under the trademark Eudragit® (see Matthews 17:25–18:3; see generally
Ans. 16).
FF 17. Matthews discloses that its composition may include “agents . . . that
may physically block migration of the antagonist from the subunit and/or
enhance the hydrophobicity of the barrier,” such as talc (Matthews 20:27–
30; see also id. at 21:10–12 (Matthews discloses that “the function of
talc . . . is to enhance the hydrophobicity and therefore the functionality of
the sequestering polymer”); see Ans. 16).
FF 18. Examiner finds that Matthews discloses ratios of talc:Eudragit, in a
range from 69–151% (see Ans 16 (citing Matthews 21:20–24).
ANALYSIS
The rejection over the combination of Meier, Tomuta, and Eudragit:
Based on the combination of Meier, Tomuta, and Eudragit, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious to modify Meier’s pharmaceutical composition by
adding 16% HPMC by weight of the polymer mixture, as taught by Tomuta,
to Meier’s core coating composition in order to modify the pharmaceutical
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compositions delayed release profile (see Ans. 14). In this regard, Examiner
asserts that Meier’s disclosure that the polymer coating may be 20% by
weight in relation to the weight of the active ingredient-containing core “is
close to [Appellant’s] claimed range [of] . . . at least 30%” (Ans. 10
(emphasis added); see also FF 4). Examiner also calculates that the
“maximal amount of talc,” i.e. non-porous inert lubricant, in Meier’s
composition “is 107% of the dry weight of the polymer mixture” and
concludes that 107% “is close to [Appellant’s claimed non-porous inert
lubricant] . . . amount of 140%” (Ans. 11 (emphasis added); see also id. at
14 (citing In re Aller, 220 F.2d 454, 456 (CCPA 1955)).
Based on the foregoing analysis of Meier and Tomuta, Examiner
concludes that
the coated pharmaceutical formulation taught by MEIER and
TOMUTA necessarily has the recited degree of release with or
without the addition of 40% ethanol because MEIER and
TOMUTA teach the recited reagents (drug, talc, HPMC,
EUDRAGIT NE 30 D, and EUDRAGIT FS 30 D) in the recited
amounts [and] . . . MEIER also teaches alteration of coating
thickness which is a variable known to influence
pharmaceutical release.
With regard to storage stability (expressed as an f2-
value) . . . , the coated pharmaceutical formulation taught by
MEIER and TOMUTA necessarily has the recited degree f2-
value because MEIER and TOMUTA teach the recited reagents
(drug, talc, HPMC, EUDRAGIT NE 30 D, and EUDRAGIT FS
30 D) in the recited amounts [and] . . . MEIER [further] teaches
inclusion of processing aids in the coatings/layers of the
composition to provide reliable and reproducible good long-
term storage stability.
(Ans. 15 (citing In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990); see also
FF 1–12.) We are not persuaded.
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We recognize that an obviousness rejection may be appropriate when
the prior art teaches that the end points of its range are approximate, or can
be flexibly applied. See In re Brandt, 886 F.3d 1171, 1177 (Fed. Cir. 2018)
(citing In re Patel, 566 Fed. Appx. 1005, 1010 (Fed. Cir. 2014)) (“[P]rima
facie rejections may be appropriate ‘where there is a teaching in the prior art
that the end points of the prior art range are approximate, or can be flexibly
applied’”). On this record, however, Examiner failed to establish an
evidentiary basis to support a finding that the prior art ranges for talc or the
pharmaceutical’s coating layer are so flexible that a person of ordinary skill
in this art would understand them to extend from the prior art non-porous
inert lubricant, i.e. talc, endpoint of 107%, as calculated by Examiner, to
Appellant’s claimed range of 140–250% or from the prior art coating layer
endpoint of 20% to Appellant’s claimed range of 30–200% (see Appeal Br.
32–34 (Appellant contends that Examiner’s conclusion lack an evidentiary
basis on this record); see also Reply Br. 7).
We appreciate Examiner’s assertion that although Meier prefers the
coating layer to range from 2% to 20% by weight, Meier’s preference places
“no upper limit [on] the amount of polymer coating placed onto the core”
and that the thickness of the coating layer can be increased or reduced in
order to control the release of active agent (see Ans. 22–23; see also FF 4).
See In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971) (Disclosed examples and
preferred embodiments do not constitute a teaching away from a broader
disclosure or non-preferred embodiments.). We find, however, that
Examiner failed to establish an evidentiary basis on this record to support a
conclusion that because the prior art end points are “close to” the ranges
required by Appellant’s claims those of ordinary skill in this art would have
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exercised routine optimization to modify the prior art ranges to necessarily
arrive at Appellant’s claimed invention (see Ans. 10–11). See In re Stepan
Co., 868 F.3d 1342, 1346 (Fed. Cir. 2017) (“Missing from the Board’s
analysis is an explanation as to why it would have been routine optimization
to arrive at the claimed invention.”); see also 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.”).
To be clear, although the combination of Meier, Tomuta, and Eudragit
may make obvious a controlled release formulation, wherein drug is released
in the GI tract,12 Appellant’s claimed formulation exhibits specific release
rates in the presence or absence of ethanol. What is missing from
Examiner’s rationale is a reason why one of ordinary skill in this art would
want to modify Meier with Tomuta and Eudragit to achieve the specific drug
release profile recited in Appellant’s claims. Thus, we are not persuaded by
Examiner’s conclusion that a person of ordinary skill in this art would have,
absent hindsight, selected the appropriate reagents from Meier, Tomuta, and
Eudragit, optimized their amounts to those amounts required by Appellant’s
claimed invention, and combined the optimized reagents in such a manner as
to arrive at Appellant’s claimed invention. See In re NTP, Inc., 654 F.3d
1279, 1299 (Fed. Cir. 2011) (Fed. Cir. 2011) (“Care must be taken to avoid
hindsight reconstruction by using ‘the patent in suit as a guide through the

12 Examiner finds that Meier discloses “optimizing the release of the active
agent to advantageously administer active agent to the lower sections of the
intestine” (Ans. 26 (citing Meier ¶ 201))
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maze of prior art references, combining the right references in the right way
so as to achieve the result of the claims in suit.’”).
For the foregoing reasons, we find that Examiner failed to establish
that the general conditions of Appellant’s claimed invention are disclosed in
the prior art (cf. Ans. 14 (citing Aller, 220 F.2d at 456)). To the contrary, as
Appellant explains, Examiner failed to establish an evidentiary basis on this
record to support a finding that the combination of Meier, Tomuta, and
Eudragit
would have reasonably suggested to the ordinary artisan that
increasing the weight of the coating layer relative to the weight
of the active ingredient-containing core and increasing the
amount of a non-porous inert lubricant such as talc, . . . would
affect the combination of Gastric resistance, Ethanol resistance,
and Storage stability of the controlled release pharmaceutical
compositions Meier discloses.
(Appeal Br. 36.) “If the prior art does not recognize the result effective
variable, persons having ordinary skill in the art would have had no reason,
incentive, motivation, etc., to modify a variable to optimize the desired
result” (id.).
To be complete, we note that inherency “may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.” In re Robertson, 169
F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks
omitted). For the reasons set forth above, we find that Examiner failed to
establish an evidentiary basis on this record to support a conclusion that the
combination of Meier, Tomuta, and Eudragit would have led a person of
ordinary skill in this art to a composition that inherently exhibits the
properties of Appellant’s claimed compositions (see Appeal Br. 35 (citing
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Robertson, 169 F.3d at 745); Reply Br. 8; cf. Ans. 25 (Examiner asserts that
“Appellant’s properties of gastric resistance, ethanol resistance, and storage
stability are properties inherent to the pharmaceutical dosage form and its
reagents”)).

The rejection over the combination of Meier, Tomuta, Eudragit, and
Matthews:
Examiner relies on the combination of Meier, Tomuta, and Eudragit
as discussed above (see Ans. 15). We, therefore, incorporate our analysis of
the combination of Meier, Tomuta, and Eudragit herein by reference.
Examiner recognizes the combination of Meier, Tomuta, and Eudragit
fails to make obvious a composition comprising “inert lubricant[, i.e.
talc,] . . . in an amount of 140-220% by weight calculated on dry weight of
the polymer mixture” and relies on Matthews disclosure of a delayed release
pharmaceutical formulation comprising a talc:Eudragit ratio of 69–151% to
make up for this deficiency (id. at 16). Thus, based on the combination of
Meier, Tomuta, Eudragit, and Matthews, Examiner concludes that, at the
time Appellant’s invention was made, it would have been prima facie
obvious
to have modified the delayed release pharmaceutical
formulation suggested by the combined teachings of MEIER
and TOMUTA by adjusting the talc:Eudragit ratio to be
69-151 % as taught by MATTHEWS because both MEIER and
MATTHEWS teach coatings/layers for pharmaceutical
formulations which delay the release of the active agent
contained by them. The skilled artisan would have been
motivated to modify the delayed release pharmaceutical
formulation suggested by the combined teachings of MEIER
and TOMUTA by adjusting the talc:Eudragit ratio to be
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69-151 % as taught by MATTHEWS, with an expectation of
success, based upon MATTHEWS[’] teachings that talc
physically blocks the migration of the drug out of the
pharmaceutical formulation, increases the hydrophobicity of the
coating/layer, and dramatically alters the release profiles of the
drug from the formulation.
(Ans. 17 (citing Aller, 220 F.2d at 456); see FF 1–18.)
We are not persuaded.
As discussed above, and recognized by Examiner, the combination of
Meier, Tomuta, and Eudragit fails to make obvious, inter alia, a composition
comprising a coating layer that comprises 140–250% by weight of a non-
porous inert lubricant, i.e. talc (see e.g., Ans. 16). Although Examiner relies
on Matthews to disclose a talc:Eudragit ratio of 69–151%, Examiner failed
to establish an evidentiary basis to support a conclusion that this ratio of talc
to Eudragit would have necessarily led a person of ordinary skill in this art
to a coating layer that comprises talc in an amount of 140–250% by weight,
as required by Appellant’s claimed invention.
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1, 3, 7–12, 14–21, and 24–27 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Meier, Tomuta, and
Eudragit is reversed.
The rejection of claims 1, 3, 7–12, 14–21, and 24–27 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Meier, Tomuta, Eudragit,
and Matthews is reversed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 7–12,
14–21,
24–27
112, first
paragraph
Written Description 1, 3,
7–12, 14–
21, 24–27
1, 3, 7–12,
14–21,
24–27
112, second
paragraph
Indefiniteness 1, 3,
7–12, 14–
21, 24–27
1, 3, 7–12,
14–21,
24–27
103(a) Meier, Tomuta,
Eudragit
1, 3,
7–12, 14–
21, 24–27
1, 3, 7–12,
14–21,
24–27
103(a) Meier, Tomuta,
Eudragit, Matthews
1, 3,
7–12, 14–
21, 24–27
Overall
Outcome
1, 3,
7–12, 14–
21, 24–27
REVERSED