Capsugel Belgium NV

Patent Trials and Appeals Board

Jul 28, 2021

2020006281 (P.T.A.B. Jul. 28, 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.
15/500,493 01/30/2017 Keith Hutchison 9156-98107-02 3332
120501 7590 07/28/2021
Klarquist Sparkman, LLP (Capsugel)
121 SW Salmon Street, Suite 1600
Portland, OR 97204
EXAMINER
ROSENTHAL, ANDREW S
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
07/28/2021 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):
docketing@klarquist.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KEITH HUTCHISON and TAKAHISA TAKUBO

Appeal 2020-006281
Application 15/500,493
Technology Center 1600
____________

Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
TAWEN CHANG, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected the claims under 35 U.S.C. § 103 as obvious.
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s
decision to reject the claims. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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 Capsugel
Belgium NV. Appeal Br. 4.
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STATEMENT OF THE CASE
The Examiner rejected claims 15, 17–19, 21–26, and 28–30 in the
Non- Final Office Action (Dec. 5, 2019) (“Non-Final Act.”) as follows:
Claims 15, 17–19, 21–26, and 28–30 under 35 U.S.C. § 103 as
obvious in view of Uyama (JP2010202550 A, Sept. 16, 2010; in Japanese
language; machine translation provided and relied upon herein) (“Uyama”),
Kalepu et al., Acta Pharmaceutica Sinica B, 3(6): 361–372 (2013)
(“Kalepu”), and Tochio et al. (WO 2006/070578 A1, July 6, 2006; in
Japanese language; translation provided and relied upon herein) (“Tochio”).
Non-Final Act. 10.
Claims 15, 17–19, 21–26, and 28–30 under 35 U.S.C. § 103 as
obvious in view of Capsugel Launch2 (March 7, 2011) (“Capsugel Launch”)
and Kalepu, “as evidenced” by Capsugel Slides3 (May 24, 2016) (“Capsugel
Slides”). Non-Final Act. 18.
Independent claim is representative and copied below:
15. A dosage form, comprising:
an acid resistant hard capsule comprising a water soluble
film forming polymer and gellan gum, wherein the water
soluble film forming polymer and the gellan gum are present at
a weight ratio of 4 to 15 parts by weight of gellan gum relative
to 100 parts by weight of the water soluble film forming
polymer;
and
a fill composition encapsulated by the acid resistant
capsule, the fill composition comprising
an active ingredient selected from a
pharmaceutical, a dietary supplement, a peptide, an amino acid,

2 https://www.capsugel.com/news/capsugel-launches-drcaps-capsules-for-
acid-sensitive-products-taste-masking.
3 http://www.jigsawhealth.com/content/dr-capsules-from-capsugel-
presentation.pdf).
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a protein, a glycoprotein, an enzyme fermented food, an
enzyme, a coenzyme, a vitamin, a living microbe, a plant
extract, propolis, or any combination thereof; and
an oil acceptable for pharmaceuticals or foods,
wherein the oil has a specific gravity of 0.95 or lower.

OBVIOUSNESS REJECTIONS
One rejection is based on Uyama, Kalepu, and Tochio, and the second
rejection is based on Capsugel Launch and Kalepu. Because Appellant’s
arguments are similar for both rejections, we have addressed them together.
Claim 15 is directed to a “dosage form” that comprises an acid
resistant hard capsule and a fill composition. The fill composition comprises
an active ingredient and an oil which has a specific gravity of 0.95 or lower.
The Examiner found that each of Uyama and Capsugel Launch describe a
dosage form comprising an acid resistant hard capsule with the claimed
characteristics and a fill composition as claimed. Non-Final Act. 10, 18.
However, the Examiner found that Uyama and Capsugel Launch do not
disclose that an oil is present in the fill composition as required by the claim.
Id. at 12, 18. For this feature of the claim, the Examiner cited Kalepu. Id.
The Examiner found that Kalepu teaches that “encapsulating a drug in
a lipid excipient can lead to increased solubilization and absorption,
resulting in enhanced bioavailability (abstract).” Id. The Examiner further
found that Kalepu describes olive oil as one such lipid excipient, which has a
specific gravity of 0.91, meeting the corresponding limitation of the claim.
Id. at 12–13. The Examiner concluded it would have been obvious to one of
ordinary skill in the art to use an oil in the acid resistant hard capsule of each
of Uyama and Capsugel Launch to enhance the bioavailability of the
encapsulated active ingredient. Id. at 13, 20. The Examiner relied on Tochio
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for describing certain minerals that can be included in a pharmaceutical
dosage form. Id. at 12.
Appellant contends that the claimed dosage form is not obvious
because the inventors recognized a problem that was previously unknown
and solved it by providing an oil with a specific gravity of 0.95 or less.
Appeal Br. 7. Appellant also argues that there would have been no
motivation to have combined the capsule of each of Uyama and Capsugel
Launch with Kalepu’s oil and that any such combination is impermissible
hindsight. Appeal Br. 9.
We begin by determining whether the Examiner provided sufficient
evidence to establish prima facie obviousness of claim 15. “An examiner
bears the initial burden of presenting a prima facie case of obviousness.” In
re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). “The test for
obviousness is what the combined teachings of the references would have
suggested to one of ordinary skill in the art,” In re Young, 927 F.2d 588, 591
(Fed. Cir. 1991); i.e., “whether the teachings of the prior art, taken as a
whole, would have made obvious the claimed invention.” In re Gorman, 933
F.2d 982, 986 (Fed. Cir. 1991).
The Examiner’s reason to add an oil to the capsule described in each
of Uyama and Capsugel Launch is based on Kalepu. Kalepu discloses:
The formulation of drugs is carried out with the principle [sic]
objective of enhancing their bioavailability. Poorly water
soluble drugs are challenging for the formulation scientists with
regard to solubility and bioavailability. Lipid-based drug
delivery systems (LBDDS) are one of the emerging
technologies designed to address such challenges.
Encapsulating or solubilizing the drug in lipid excipients can
lead to increased solubilization and absorption, resulting in
enhanced bioavailability. Recent advances in these formulation
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technologies have led to the successful commercialization of
lipid-based formulations.
Kalepu 361 (Abstract).
Kalepu further explains:
A water-insoluble drug can be formulated as a lipid-based
formulation when the drug itself is an oil-like substance (e.g.,
ethyl icosapentate, tocopherol nicotinate, teprenone,
indomethacin farnesyl and dronabinol), or when conventional
formulation approaches like granulation or soluble liquids in
capsules do not enhance the oral bioavailability. A variety of
lipid-based systems composed of simple oil solutions to
complex mixtures of oils, cosolvents, surfactants and co-
surfactants can be obtained based on the type of excipients and
formulation variables. Indeed, these systems can be converted
to solid intermediates (powders, granules and pellets) by
various techniques and can be filled in hard gelatin capsules or
can be compressed into tablets after blending with suitable
tableting excipients.
Kalepu 362.
Kalepu further discloses that oral delivery is “preferred” and
“popular” and states that the formulations comprising the oil can be “filled
into capsules.” Kalepu 367.
Kalepu also discloses that olive oil can be used as the oil in a lipid-
based formulation for a poorly water soluble drug, which the Examiner
found, based on the disclosure in the Specification, has a specific gravity of
0.91, within the claimed range of 0.95 of less. Kalepu 364 (Table 1); Spec. ¶
12 (Table 1)
Because Kalepu describes the advantages of an oil for increasing a
drug’s bioavailability, as well as its use in a capsule, the Examiner’s
conclusion that one of ordinary skill in the art would have had reason to use
olive oil in the capsule described by Uyama and Capsugel Launch to
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increase the bioavailability of a “[p]oorly water soluble drug” when used as
an active ingredient is supported by the evidence in this record.
Appellant argues that “Uyama is solely concerned with solving the
problem of high manufacturing costs (and low productivity) associated with
adding enteric coatings to capsules by providing an acid resistant capsule
that is inherently acid resistant.” Appeal Br. 9. Appellant also argues that
“Capsugel Launch is concerned with solving the problem of high production
costs and time associated with adding a separate chemical coating to the
capsule to protect against early activation caused by stomach acid.” Id. at 17.
Thus, Appellant argues that the addition of an oil to the capsule would not
have been obvious because it would add to the cost of the product. Id. at 8–
10, 13.
This argument is not persuasive. Appellant has not provided objective
evidence that these factors would have deterred one of ordinary skill in the
art from using oil in the capsule for its known and expected advantages. As
held in Orthopedic Equip. Co., Inc. v. United States, 702 F.2d 1005, 1013
(Fed. Cir. 1983) (brackets in original):
the fact that the two disclosed apparatus [sic] would not be
combined by businessmen for economic reasons is not the same
as saying that it could not be done because skilled persons in
the art felt that there was some technological incompatibility
that prevented their combination. Only the latter fact is telling
on the issue of nonobviousness.
See also Grit Energy Solutions, LLC v. Oren Technologies, LLC, 957 F.3d
1309, 1323–1324 (Fed. Cir. 2020) (“Thus, even if we accept the Board’s
factual determination that swapping Eng Soon’s components would result in
a more expensive system, that determination, standing alone, is insufficient
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to reject each of Grit Energy’s arguments as to why a skilled artisan would
have been motivated to make the proposed swap.”)
Appellant further argues that there is “no indication in Uyama that
decreased bioavailability was of any concern with its dosage forms” and a
person of ordinary skill in the art “would not have had any reason to believe
that adding Kalepu’s oil to a fill for Uyama’s capsules would even be
necessary to enhance bioavailability and/or that this would provide any
additional advantage.” Appeal Br. 10. Appellant contends that the
modification proposed by the Examiner “would amount to extra work and
greater cost for no apparent reason other than solving the unrecognized
problem that the present inventors discovered (as discussed above).” Id.
With respect to Kalepu, Appellant states that the publication “is entirely
directed to lipid-based drug delivery systems used to enhance bioavailability
of poorly water soluble drugs and is completely unrelated to acid resistant
capsules and issues associated with such capsules. Kalepu, Abstract.” Id. at
9. Appellant states that “Kalepu has no disclosure regarding any delivery
systems other than gelatin capsules (or tablets).” Id.
Appellant’s argument addresses each of the publications separately
without considering what the combination would have suggested to one of
ordinary skill in the art. An explicit suggestion to modify the prior art is
unnecessary to establish obviousness. KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 415 (2007). KSR held that an obviousness “analysis need not seek
out precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” Id. at 418. Here, while
Uyama may have been silent on the existence of a problem with a drug in its
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capsule, such fact does not detract from the obviousness of utilizing
Kalepu’s oil in each of Uyama’s and Capsugel Launch’s capsules.
Specifically, Kalepu identifies a problem with the bioavailability of a poorly
soluble drug and describes the solution to this problem as utilizing a lipid
excipient for “increased solubilization and absorption, resulting in enhanced
bioavailability.” Kalepu, Abstract. As indicated by Appellant, the focus of
Uyama and Capsugel Launch is on creating an acid resistant capsule (e.g.,
Appeal Br. 9, 17), but as discussed by Kalepu, there are other problems to be
addressed when using oral drug delivery systems, such as drug solubility.
Appellant, by focusing on the publications individually, has failed to
appreciate in their arguments that Uyama, Capsugel Launch, and Kalepu
provide evidence that, when formulating a capsule for oral delivery that
doesn’t dissolve in the stomach and that comprises a poorly soluble drug, the
ordinarily skilled worker would be concerned with the drug bioavailability4
when released from the capsule and the ability of the capsule, itself, to resist

4 “With the advent of drug design, various molecules have been created that
have a potential for therapeutic action. But most of the newly discovered
chemical entities are of high molecular weight and belong to
biopharmaceutical classification system (BCS) - II, with poor aqueous
solubility and high membrane permeability. Hence these two characteristics
limit the bioavailability of orally administered drugs. These drugs have low
solubility which leads to low dissolution and limits absorption. This poor
solubility not only gives low oral bioavailability but also leads to high inter-
and intra-subject variability and lack of dose proportionality. Also, some of
these drugs have enhanced bioavailability when coadministered along with
food . . . In order to formulate such drugs in a safe and efficacious form, a
balance must be maintained between bioavailability, toxicity and disposition
within the body.” Kalepu 362 (footnotes omitted).
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dissolution in the acidic stomach environment.5 “Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references.” In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986).
Appellant also argues a lack of motivation to combine the publications
because Kalepu describes a gelatin capsule, which is different from the
capsule described in Uyama and Capsugel Launch. Appeal Br. 8, 9, 17. This
argument is not persuasive because Kalepu has more general disclosure
about using capsules for oral delivery (Kalepu 367) and also because Kalepu
was concerned by the bioavailability of the drug inside a capsule, and not the
capsule, itself. Appellant has not provided objective evidence that using a
different capsule would affect the ability of its contents to become more
bioavailable when formulated with an oil and released in the intestine, once
its dissolves. Appellant has not established a relationship between the
properties of the capsule to resist degradation in the stomach and the
availability of the drug when the capsule dissolves in the intestine, releasing
its content.
Appellant further argues that the inventors were the first to recognize
that the recited specific gravity of 0.95 or lower is a result-effective variable
and thus it would not have been routine optimization to have selected it. Id.
at 9–10, 18.

5 “It was found that an enteric film capable of forming a capsule by a
dipping method can be prepared and the thus prepared capsule has acid
resistance and is sparingly soluble in an acidic solution equivalent to gastric
juice [.] On the other hand, it was confirmed that it is easily soluble in a
neutral to weak alkaline solution equivalent to the intestinal environment.”
Uyama ¶ 7.
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This argument is not persuasive because the Examiner found that
Kalepu discloses olive oil as a lipid excipient, which falls within the scope
of the claim. Non-Final Act. 13. Consequently, there is no optimization
necessary to have arrived at an oil within the scope of the claim.
For the foregoing reason, we are not persuaded that the Examiner’s
reasoning invoked “post-hoc motivation.” Appeal Br. 9.
In arguing the nonobviousness of the claimed invention, Appellant
explains that the inventors “discovered that even though acid resistant hard
capsules do not dissolve in gastric fluid, gastric fluid can nonetheless
permeate into the capsule and degrade the active material. The inventors
believed that this was due, at least in part, to the presence of hydrophilic
component(s) present in the shell.” Appeal Br. 7. Appellant states that “[t]his
previously unrecognized problem is discussed in Appellant’s specification.”
Id. The Specification discloses:
However, while studying enteric capsule formulations that
include an acid resistant hard capsule, surprisingly the present
inventors found that even though the capsule does not
disintegrate in the stomach, over time gastric acid gradually
enters through the capsule membrane because the capsule
membrane contains a hydrophilic material. Therefore, even if a
capsule is used wherein the capsule membrane itself is acid
resistant, in cases wherein the efficacy of an encapsulated active
ingredient is reduced by a small amount of gastric acid (gastric
juice), there is a possibility that the active ingredient will
deteriorate (changes/be dispersed/be annihilated) when the
active ingredient comes in contact with acid (gastric acid), and
the expected effect will not be obtained sufficiently.
Spec. ¶ 5.
The Specification discloses that the “the present inventors found that
the above problems could be resolved by developing a capsule formulation
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having the following configuration.” Spec. ¶ 6. The configuration described
in the Specification includes:
(1) A capsule formulation comprising an active ingredient and
oil, wherein said capsule of said formulation is an enteric
capsule including a water soluble film forming polymer and
gellan gum, said oil is an oil acceptable for pharmaceuticals or
food, and said active ingredient is encapsulated in said capsule
together with said oil.
Spec. ¶ 9.
(3) The capsule formulation according to (1) or (2), wherein the
weight ratio of said water soluble film forming polymer and
said gellan gum in said capsule is 4 to 15 parts by weight of
gellan gum relative to 100 parts by weight of said water soluble
film forming polymer.
Spec. ¶ 11.
While the description in the Specification of the capsule formulation
that resolves the stated problem discloses the presence of an oil in the
capsule, it does not solely attribute the solution to the oil nor does it require
that the oil to have a specific gravity of 0.95 or lower as required by the
claim. Spec. ¶¶ 7–14.
The Specification further explains:
One aspect of the capsule formulation according to the present
invention is being able to protect an active ingredient that may
deteriorate (change/be dispersed/be annihilated) when it comes
into contact with acid (gastric acid) seeping into a capsule. That
is, even if oil is mixed with acid (gastric acid), due to having
separating immiscible properties, acid (gastric acid) seeping
into the capsule sinks to the bottom of the capsule because of
the difference in the specific gravity of oil without being
diffused into an encapsulated oil acceptable for pharmaceuticals
or food. Therefore, contact between an acid and an active
ingredient can be effectively reduced by separating both the
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aqueous phase (including acid) and the oil phase (including an
active ingredient) within a capsule.
Spec. ¶ 22.
Thus, the Specification teaches how the oil protects the active
ingredient from deteriorating in the capsule, but does not require its specific
gravity to be 0.95 or lower as required by the claims. Rather, the value of
0.95 or lower is described as one of the preferred ranges:
[I]t is preferable that the specific gravity (density ratio with
water as a standard) of oil in the present invention be 0.96 or
lower, wherein 0.955 or lower is more preferable, 0.95 or lower
is even more preferable, 0.945 or lower is still more preferable,
and 0.94 or lower is still even more preferable. Surprisingly, the
present inventors found that the more the specific gravity of oil
is separated from that of water, the easier it became to
physically separate within the capsule the oil (oil phase) and
acid (aqueous phase) seeping into the capsule, and the acid and
oil (including an active ingredient or the like) mixed less easily,
protecting the active ingredient or the like from the acid.
Spec. ¶ 34.
To address Appellant’s argument that the claimed subject matter is not
obvious because the inventors solved an unrecognized problem, we must
consider two legal principles.
First, as explained In re Baxter Travenol Labs, 952 F.2d 388, 392
(Fed. Cir. 1991),
[m]ere recognition of latent properties in the prior art does not
render nonobvious an otherwise known invention. In re
Prindle, 297 F.2d 251, 254, 132 USPQ 282, 283–84 (CCPA
1962). Since the prior art bags plasticized with DEHP were
inherently suppressing hemolysis, albeit unknown at the time of
the Becker document, this hemolysis-suppressing function is
not a basis for rebutting a prima facie finding of obviousness.
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The second principle has to do with “criticality.” As explained in In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990):
The law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims . . . in such a situation, the applicant
must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results
relative to the prior art range.
As explained above, Kalepu provides a reason to use oil in a capsule.
When Kalepu’s guidance is followed, the bioavailability of the poorly
soluble drug would be enhanced and the drug would be protected from the
deleterious effects of gastric acid when encapsulated in the capsule
described by each of Uyama and Capsugel Launch. Therefore, using the oil
as described in Kalepu, would inherently impart protection against gastric
acid, albeit not recognized at the time of the publication. The observed
property for the oil described in the Specification (see ¶¶ 22, 34) is “latent”
or “inherent” to using the oil for the purpose described in Kalepu. This
determination is consistent with Baxter. In Baxter, blood bags plasticized
with DEHP had been used in the prior art. Baxter, 952 F.2d at 392. The
inventors discovered that such blood bag also suppressed hemolysis of the
blood. Id. But the court found this newly discovered property to insufficient
to rebut the prima facie finding of obviousness because it was a latent,
inherent property of using the blood bag. Id. Similarly, while the inventors
discovered that oil has an additional beneficial property when used in a
capsule, Kalepu disclosed adding an oil to an active ingredient in a capsule,
and therefore the capsule would have exhibited this property, despite the
property not being recognized at the time of Kalepu’s publication.
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We therefore must next ask whether there is anything critical about
the selection of the oil having a specific gravity of 0.95 or less. In other
words, to establish non-obviousness, Appellant must show the “criticality”
of the range of specific gravity values selected for the oil, alone, or in
combination with the claimed capsule.
To address this, we look at the data disclosed in the Specification. The
Specification describe an experiment in which a capsule within the scope of
the claim was prepared with an active ingredient formulated with an oil and
compared to the same capsule in which a surfactant (glycerin fatty acid ester
or sorbitan fatty acid ester) was placed in the capsule instead of the oil. Spec.
¶¶ 48, 51. The capsules were submerged in an acid solution “to simulate the
gastric acid inside a living organism.” Spec. ¶ 49. A litmus reagent, which
changes color from blue to red in an acid environment, was used as the
active ingredient to determine whether the oil protected the active ingredient
when placed in the acid solution. Id.
Table 1 of the Specification shows the eight different oils (1-
safflower, 2-olive, 3-soybean, 4-linseed, 5-DHA, 6-rice germ, 7-vitamin E,
8-vitamin A) which were tested. Spec. ¶ 51. Seven of the oils were rated as
“excellent” with respect to protecting against acidification inside the
capsule, while only one oil (DHA) was “passable.” DHA has a specific
gravity of 0.95, while the other oils were from 0.91 to 0.94. The
Specification states:
Importantly, all oils that obtained a “++” result had a specific
gravity of 0.94 or lower. This suggests that the more the
specific gravity of oil is separated from that of water, the easier
it becomes to physically separate oil from acid seeping into the
capsule, and the less easily it is mixed with acid.
Spec. ¶ 52.
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The data provided in the Specification does not show that the range of
0.95 or lower is critical to preventing acidification of the active ingredient.
No values of an oil having a specific gravity above 0.95 were shown, and the
Specification, itself, only describes 0.95 or lower as “more preferable.”
Spec. ¶ 34. The data shows that a value of 0.94 or lower is better than 0.95,
but this range is not claimed. Thus, it cannot be discerned from this data that
the choice of an oil having a specific gravity of 0.95 or lower provided any
benefit that is not possessed by the oils described in Kalepu having a higher
specific gravity.
The proper comparison to establish criticality and nonobviousness of
the claimed range is with the oils described in Kalepu because the
comparison must be with the closest prior art and Kalepu is the closest prior
art. Baxter, 952 F.2d at 392. Appellant did not provide evidence that the oils
described in Kalepu having a specific gravity higher than 0.95 would not
inherently provide the advantages described in the Specification. While we
agree with Appellant that their data shows that specific gravity is a result-
effective variable with respect to reducing acidification in a gastric acid
simulated environment (Appeal Br. 15), this property is still, absent evidence
to the contrary, inherent to the teaching in Kalepu to use oil in a capsule
because Appellant did not establish the criticality of the claimed range in
preventing or reducing acidification of the active ingredient.
We also must consider whether it has been established that the
claimed capsule in combination with an oil of specific gravity of 0.95 or
lower, is critical to reducing the deterioration of an active ingredient when in
contact with gastric acid.
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While Kalepu refers to gelatin capsules, as explained above, there is
broader disclosure on capsules generally. Appellant did not show that the
choice of the capsule is critical, namely, that the capsule described in Uyama
and Capsugel Launch behaves any differently with respect to active agent
bioavailability as compared to other capsule types, such as the gelatin
capsule describe by Kalepu. Only one type of capsule is used in the
experiments described in the Specification. Therefore, Appellant has not
demonstrated the criticality of the combination of capsule and oil having a
specific gravity of 0.95 or lower.
Appellant argues that Leo Pharmaceutical Products, Ltd. v. Rea, 726
F.3d 1346 (Fed. Cir. 2013) dictates a different result. Appeal Br. 8. We do
not agree.
Leo was an appeal from a decision by the Board affirming an
obviousness rejection in a reexamination of a patent. In Leo, the claim was
directed to a pharmaceutical composition for dermal use which comprised a
vitamin D analogue, a corticosteroid, and a specific type of solvent. Leo, 726
F.3d. at 1349. The claims were rejected as obvious under 35 U.S.C. § 103.
Two publications were cited in the rejection, Dikstein and Serup, which
“attempt the combination of a vitamin D analog with a corticosteroid” but
“neither discloses or addresses the stability problems of combining vitamin
D analogs and corticosteroids into one pharmaceutical formulation.” Id. at
1354. The Board had cited Turi for the solvent POP-15-SE that fell within
the scope of the claimed solvent. Id. at 1350. Turi disclosed pharmaceutical
compositions comprising a steroid and POP-15-SE, but not vitamin D. Id. at
1350. The Board found it obvious to use POP-15-SE as the solvent for the
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combination of steroid and vitamin D of Dikstein and Serup, but the court
reversed the Board’s decision. The court held:
because neither Dikstein nor Serup recognized or disclosed the
stability problem, the record shows no reason for one of
ordinary skill in the art to attempt to improve upon either
Dikstein or Serup using Turi. The ordinary artisan would first
have needed to recognize the problem, i.e., that the
formulations disclosed in Dikstein and Serup were not storage
stable.
Id. at 1354.
The facts are not the same in this appeal. In Leo, unlike here, the court
found there was no reason that would have prompted one of ordinary skill in
the art to have used POP-15-SE in the pharmaceutical compositions of
Dikstein and Serup, both of which were aqueous compositions, while Turi’s
was not. Leo established that its composition containing all three ingredients
was storage-stable, as compared to the “significant degradation” observed in
the Dikstein and Serup compositions which was determined to be a “a strong
indication that the . . . patent’s combination of known elements yields more
than just predictable results.” Id. at 1358. The court concluded that “[t]his
record shows ‘extensive experimental evidence’ of unexpected results.” Id.
Here, the Examiner established an adequate reason, supported by a
preponderance of the evidence, to have used an oil in the specific type of
capsule described by each of Uyama and Capsugel Launch. Such oil was in
fact disclosed as useful in a capsule and thus adding it to the capsule of each
of Uyama and Capsugel Launch was merely following the straightforward
guidance in Kalepu and using the oil for its expected benefit in enhancing
bioavailability. In contrast, the court in Leo decided there was no reason to
use the POP-15-SE solvent in Dikstein and Serup, and Turi had not
Appeal 2020-006281
Application 15/500,493

18
described the solvent as useful for both vitamin D and the steroid. Leo’s
evidence was also considered to establish unexpected results, a finding
lacking in this record.
Appellant also cited In re Omeprazole Patent Litigation, 536 F.3d
1361 (Fed. Cir. 2008), in arguing the nonobviousness of the claim. Appeal
Br. 8, 13. However, Omeprazole is distinguishable because in that case the
Federal Circuit found a lack of a reason to have combined the cited
publications. Id. at 1380–1381. But, here, a fact-based and logical reason,
supported by the evidence in this record, establishes a reason to combine the
oil of Kalepu with capsules of Uyama and Capsugel Launch.
In sum, for the foregoing reasons, we affirm the Examiner’s
conclusion that claim 15 is obvious over each of Uyama and Capsugel
Launch, and Kalepu. Appellant acknowledges that dependent claims 17, 19,
21–25, 28, and 29, which depend from independent claim 15, fall with it.
Appeal Br. 18.

Claim 18
Claim 18 depends from claim 15 and further recites “wherein the oil is
present in an amount not less than 40% by weight of a total amount of the
fill composition.” Appellant contends that the Examiner’s rejection is based
on the presence of surfactant, but a surfactant is not required by the claim.
Appeal Br. 18. This argument is unavailing because the claim is open-ended
and therefore a surfactant is not excluded from the claim.

Appeal 2020-006281
Application 15/500,493

19
Claims 26, 30
Appellant makes substantially the same argument for claim 26 as for
claim 15. Appeal Br. 19–21. The obviousness rejections of claim 26 are
therefore affirmed for the same reasons. Appellant acknowledges that
dependent claim 30, which depends from claim 26, falls with it. Appeal Br.
21.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
15, 17–
19, 21–
26, 28–
30
103 Uyamu, Kalepu,
Tochio
15, 17–19,
21–26, 28–
30

15, 17–
19, 21–
26, 28–
30
103 Capsugel Launch,
Kalepu, Capsugel
Slides
15, 17–19,
21–26, 28–
30

Overall
Outcome
15, 17–19,
21–26, 28–
30

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED