Flamel Ireland Limited

Patent Trials and Appeals Board

Jul 20, 2021

2021002713 (P.T.A.B. Jul. 20, 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.
16/223,940 12/18/2018 Hervé Guillard 107844-606961 3918
27148 7590 07/20/2021
POLSINELLI PC
900 WEST 48TH PLACE
SUITE 900
KANSAS CITY, MO 64112-1895
EXAMINER
BROWE, DAVID
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
07/20/2021 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):
patentdocketing@polsinelli.com
rendsley@polsinelli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HERVÉ GUILLARD
Appeal 2021-002713
Application 16/223,940
Technology Center 1600
Before DONALD E. ADAMS, TAWEN CHANG, 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 directed to a packaged pharmaceutical
composition comprising immediate release and modified release components
of gamma-hydroxybutyrate (“GHB”) as being obvious and for nonstatutory
double patenting. Oral argument was heard July 1, 2021. 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(a). Appellant identifies the real party in interest as Flamel Ireland
Limited. (Appeal Br. 1.)
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STATEMENT OF THE CASE
Narcolepsy is a condition whose symptoms include, among others
excessive daytime sleepiness and cataplexy (a sudden loss of muscle tone
triggered by strong emotions), and disturbed nocturnal sleep. (Spec. ¶ 3.)
Appellant’s Specification indicates that gamma-hydroxybutyrate is a known
major treatment for narcolepsy. (Id. ¶ 4.) A commercially marketed GHB
product is XYREM, which is “formulated as an immediate release liquid
solution that is taken once immediately before bed, and a second time
approximately 2.5 to 4 hours later.” (Id. ¶ 5.)
Appellant’s Specification states that GHB is “highly water-soluble,
hygroscopic, and strongly alkaline.” (Id. ¶ 9.) The Specification also
indicates that “these properties make it difficult to formulate a product that
remains stable over time, particular in terms of dissolution during storage
and/or chemical stability.” (Id.)
Appellant’s invention is directed at a “packaged gamma-
hydroxybutyrate composition[]. . . [that] maintain[s] chemical and
dissolution stability, particularly when maintained within a defined range of
relative humidity values.” (Id. ¶ 10.)
CLAIMED SUBJECT MATTER
Claims 1, 10–15, and 17–22 are on appeal. Claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A packaged pharmaceutical composition comprising a
pharmaceutical composition within a package,
the pharmaceutical composition comprising:
a. an immediate release component comprising gamma-
hydroxybutyrate or a pharmaceutically acceptable salt thereof;
and
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b. a modified release component comprising gamma-
hydroxybutyrate or a pharmaceutically acceptable salt thereof;
and
the package having a water vapor transmission rate of less
than 7 mg/liter/day, wherein no more than 0.4% of gamma-
hydroxybutyrate in the pharmaceutical composition is converted
to gamma-butyrolactone (GBL) when stored two months at
40 °C and 75% relative humidity.
The prior art relied upon by the Examiner is:
Name Reference Date
Liang US 2006/0210630 A1 Sept. 21, 2006
Dargelas US 2009/0220611 A1 Sept. 3, 2009
Mogna US 2014/0231300 A1 Aug. 21, 2014

The following grounds of rejection by the Examiner are before us on
review:
Claims 1 and 17–22 under 35 U.S.C. § 103(a) as unpatentable over
Liang and Mogna.2
Claims 10–15 under 35 U.S.C. § 103(a) as unpatentable over Liang,
Mogna, and Dargelas.
Claims 1, 10–15, and 17–22 on the ground of non-statutory
obviousness-type double patenting as being unpatentable over claims 1–15,
27–46, 58–66, and 69–81 of U.S. Patent No. 10,272,062.

2 Claims 6 had also been rejected in the Final Action, but claim 6 has since
been cancelled. (See Advisory Action dated September 24, 2020,
continuation sheet.)
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DISCUSSION
Obviousness
The Examiner found that Liang discloses a pharmaceutical
composition for treating narcolepsy that includes both an immediate-release
component comprising GHB and a modified-release component comprising
GHB. (Final Action 9 (citing Liang, inter alia, Abstr., ¶ 27).) The
Examiner further found that Liang discloses that GHB is highly water-
soluble and hygroscopic (id. (citing Liang ¶ 5)), and that “[i]t has long been
well known in the art that gamma-hydroxybutyrate (GHB) is highly water-
soluble, hygroscopic, and susceptible to degradation by exposure to moisture
and water vapor” (Ans. 4–5). The Examiner also found that “this high
water-solubility likely leads to drug migration into the coating layer to form
pores upon exposure to water or moisture, thus allowing leakage of the
drug.” (Final Action 10 (citing Liang ¶ 5).) The Examiner further found
that Liang “employ[s] the barrier coat primarily to provide moisture
protection to prevent the leakage” of GHB. (Final Action 11.)
The Examiner found that Mogna discloses a package that may be used
to hold pharmaceuticals that is composed of two or more layers of aluminum
and where the package “is impermeable to water vapor and oxygen, with the
water vapor transmission rate being less than 1 g/m3/24 hours,” which is less
than 1 mg/L/day. (Final Action 9 (citing Mogna, inter alia, ¶¶ 13, 58, 70).)
The Examiner determined that because Mogna’s aluminum packaging
“would . . . eliminate the vulnerability of the composition of Liang to
moisture and oxygen” one of ordinary skill in the art would have been
motivated to package the Liang pharmaceutical composition therein and
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would have had a reasonable expectation that the composition would be well
protected from water vapor and oxygen. (Final Action 10–11.)
We agree with the Examiner’s findings and conclusion of
obviousness.
Appellant contests the Examiner’s obviousness rejection arguing that
the prior art does not teach the limitation on the conversion of GHB to GBL
under the required storage conditions and that there is no motivation to
combine. (See, e.g., Appeal Br. 2–3.) In addition, Appellant argues that it
has provided “substantial and persuasive evidence of unexpected results and
other secondary considerations[] refuting the obviousness rejection” that the
Examiner has improperly ignored. (Id. at 3.) We address those arguments
below.
a. The conversion limitation, which Appellant refers to as “stability”
Appellant argues that “neither Liang nor Mogna teach any percentage
stability for a GHB formulation, let alone the highly specific stability recited
by claim 1.” (Appeal Br. 5.) We do not find this argument persuasive of
non-obviousness because the stability of the composition within the
packaging is a property of the packaged material that we conclude, as the
Examiner did (Final Action 11–12), would have been inherent, absent
evidence to the contrary. “Scientific confirmation of what was already
believed to be true may be a valuable contribution, but it does not give rise
to a patentable invention.” PharmaStem Therapeutics, Inc. v. ViaCell, Inc.,
491 F.3d 1342, 1363–64 (Fed. Cir. 2007); cf. Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1364, 1367–69 (Fed. Cir. 2007) (simply because the formation
and properties of a new compound must be verified through testing does not
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mean that the compound satisfies the test for patentability “since the
expectation of success need only be reasonable, not absolute”).
Liang teaches a pharmaceutical composition with the components
required by claim 1 (see, e.g., Liang ¶¶ 27, 29, 35) and Mogna teaches a
package in which to contain pharmaceutical compositions where the
permeability to water vapor measured at 38 ºC and 90% relative humidity is
less than 1 mg/L/243 hours and the permeability to oxygen is less than 1
cc/m3/24 hours measured at 23 ºC and 100% relative humidity (see, e.g.,
Mogna ¶¶ 59–60, 70 and Table 6–7). Given the substantial impermeability
to water vapor and oxygen of Mogna’s packaging, we conclude that the
claimed stability property would necessarily be present.
[W]here[, as here,] the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the authority
to require the applicant to prove that the subject matter shown
to be in the prior art does not possess the characteristic relied
on.
In re Best, 562 F.2d 1252, 1254–55 (CCPA 1977) (quoting In re Swinehart,
439 F.2d 210, 212–13 (CCPA 1971)). “Whether the rejection is based on
‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35
U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.” In re Best, 562 F.2d at 1255. While
we agree with Appellant that inherency may not be established by
probabilities or possibilities (Appeal Br. 6), the Examiner relied on sufficient
evidence to conclude that the stability claimed would necessarily result from

3 It is not disputed that 1 g/m3 = 1 mg/L.
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the Liang composition packaged in the described Mogna sachet/blister pack,
thereby shifting the burden to Appellant to demonstrate that such stability
would not necessarily result.
Appellant did not submit testing evidence demonstrating the claimed
stability of GHB would not necessarily result. Instead, Appellant asserts that
“[t]he limitation is neither taught nor disclosed by the prior art” so “(1) how
would one of skill in the art know which of the hundreds of packaging
materials from Mogna would work?” and, “(2) knowing that GHB is highly
unstable and tends to spoil, how would one of skill in the art have any
reasonable guess at how effective it would be ( i.e., specific stability
percentage, specific time frame, specific temperature, and specific relative
humidity)?” (Appeal Br. 5–6.) Appellant’s questions, however, are not
evidence proving that the subject matter described as being obvious from the
Liang and Mogna teachings would not possess the stability characteristic
claimed. The fact that neither reference explicitly discloses the stability of
GHB claimed is not dispositive, as the rejection is one based on the
obviousness of including the composition taught by Liang in the packaging
material taught by Mogna to provide impermeability to water vapor (a
transmission rate being less than 1 mg/L/24 hours) and oxygen (less than 1
cc/m3/24 hours measured at 23 ºC and 100% relative humidity) and thus
prevent degradation of active ingredients contained within it.
“The expectation of success need only be reasonable, not absolute,”
i.e., no guarantee is needed. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364
(Fed. Cir. 2007).
[C]ase law is clear that obviousness cannot be avoided simply
by a showing of some degree of unpredictability in the art so
long as there was a reasonable probability of success. See In re
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Corkill, 771 F.2d 1496, 1500 (Fed.Cir.1985) (“Although [the
inventor] declared that it cannot be predicted how any candidate
will work in a detergent composition, but that it must be tested,
this does not overcome [the prior art’s] teaching that hydrated
zeolites will work.”).
Id. Experiments to verify stability properties of a packaged formulation are
not equivalent to the trial and error procedures often employed to discover a
new compound where the prior art gave no motivation or suggestion to make
the new compound nor a reasonable expectation of success. Cf. id. (finding
the evidence suggested reacting a known compound with a known acid to
form an acid addition salt, and that that acid addition salt form would work
for its intended purpose).
To be sure, “to have a reasonable expectation of success, one
must be motivated to do more than merely to vary all
parameters or try each of numerous possible choices until one
possibly arrived at a successful result, where the prior art gave
either no indication of which parameters were critical or no
direction as to which of many possible choices is likely to be
successful.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157,
1165 (Fed.Cir.2006) (internal quotations omitted).
Id. Here, however, Mogna specifically describes the use of its packaging
with formulations that include material “with unstable biological activity
and/or easily degradable, especially if they come into contact with the
external environment (humidity, water vapour, light and oxygen),” which
prior materials were “not suitable to guarantee sufficient stability” due to
“degradation of the active ingredient contained therein.” (Mogna ¶¶ 6, 12,
13.) Furthermore, Mogna provides a specific example of a blister
pack/sachet that prevented water vapor and oxygen ensuring good stability
of a formulation of probiotic bacteria which are known to be unstable in the
presence of water vapor and oxygen. (Id. ¶¶ 58–61, Tables 6–7.) Although
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the compound tested for stability in Mogna was not GHB, that fact alone is
not sufficient to negate obviousness, given the other teachings regarding the
barrier effect provided by the blister packaging or sachet taught in Mogna,
even considering Appellant’s declaration, as will be discussed infra.
b. Motivation to Combine and Reasonable Expectation of Success
According to Appellant, the Examiner’s rejection is based on
impermissible hindsight because Mogna does not provide “any teachings
regarding GHB or highly sensitive pharmaceuticals” but rather is concerned
with medicinal specialties that are probiotic microorganisms. (Appeal Br.
7.) Appellant argues that “the Office has failed to provide any basis for
equating microorganisms with GHB, a highly unique pharmaceutical in its
own right,” whereas Appellant has provided sworn testimony of Dr. Jason
Vaughn4 “attesting to Mogna’s failure to provide motivation to combine.”
(Id. at 8 (citing Vaughn Declaration ¶¶ 8, 15.) We do not find the foregoing
arguments persuasive. First, that Mogna describes probiotic microorganism
as an example of a medicinal specialty that would benefit from being
packaged with the described sachet, does not limit its teachings to such
microorganisms. A reference is available for all that it teaches to a person of
ordinary skill in the art. In re Lemelson, 397 F.2d 1006, 1009 (CCPA
1968); Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed.
Cir. 1989); In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). Moreover,
“‘a reference must be considered not only for what it expressly teaches, but
also for what it fairly suggests.’” In re Baird, 16 F.3d 380, 383 (Fed. Cir.
1994) (quoting In re Burckel, 592 F.2d 1175, 1179 (CCPA 1979)).

4 Declaration of Dr. Vaughn dated August 18, 2020.
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It was well known, and Mogna teaches, that “[a]gents that come from
the external environment (humidity, water vapour, light and oxygen) can
modify some chemical/physical parameters of . . . formulations [of tablets
pills, pessaries, powders, granules, suppositories, rigid capsules and soft
capsules] causing instability and loss of efficacy of the active components
contained.” (Mogna ¶ 8.) And Mogna teaches that there is a need to be able
to provide “primary packaging for bottles, vials, blister packs and sachets
that is impermeable to water vapour and oxygen” that can ensure at least a
two year shelf life while allowing for finger pressure to be able to break or
open the package. (Id. ¶ 12.) And, Mogna teaches that it determined a
blister pack made of a polyamide/multilayer material of
aluminium/polyethylene [PA/(AL)nPE] or polyamide/multilayer material of
aluminium/polyvinyl chloride [PA/(AL)nPE], where n is comprised from 2
to 10, preferably from 2 to 5, even more preferably from 3 to 4 and the first
layer of aluminum has a thickness of 20 microns and the second layer has an
aluminum thickness of 9 microns provides for oxygen impermeability and
water vapor and humidity impermeability of less than 1 mg/L/24 hours that
supports active agent stabiilty. (Id. ¶¶ 14–16, 70.) Moreover, Mogna
provides exemplification of a specific packaging material made into a blister
pack that provided for stability of an active compound stored within it. (Id.
¶¶ 58–61, Tables 6–7.)
While it is true that Mogna notes that microorganisms are active
ingredients whose efficacy and stability can be compromised by humidity,
water vapor, and oxygen (id. ¶ 8), one of ordinary skill in the art would be
aware that GHB is a chemical whose stability also is affected by the
presence of water vapor and humidity (see, e.g., Liang ¶ 5). Indeed,
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Appellant does not dispute the Examiner’s finding that it was well known in
the art that GHB is water-soluble and hygroscopic, and susceptible to
degradation by exposure to moisture and water vapor.
As such, we agree with the Examiner that one of ordinary skill in the
art would have considered the teachings of Mogna’s multilayer blister pack
construction as just discussed and its moisture and oxygen impermeability
qualities to be relevant to a pharmaceutical composition of GHB to be used
for narcolepsy as described in Liang. “[T]he 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.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007). “When not from the prior art references, the
‘evidence’ of motive will likely consist of an explanation of the well-known
principle or problem-solving strategy to be applied.” Dystar Textilfarben
Gmbh & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1366
(Fed. Cir. 2006) (emphases in original, quoting In re Dembiczak, 175 F.3d
994, 999 (Fed. Cir. 1999)). Here, as the Examiner noted, whether or not
Mogna addressed the specific compound GHB has little bearing on whether
one of ordinary skill in the art armed with the teachings of Mogna would
have found it obvious to have used the packaging taught thereby with GHB,
as “Mogna is concerned with precisely the very problem at issue here, i.e.
how to protect moisture sensitive agents from the detrimental effects of
moisture.” (Ans. 9.)
Furthermore, we do not find the expert testimony of Dr. Jason Vaughn
persuasively establishes there was no motivation to combine. “An expert
opinion is no better than the soundness of the reasons supporting it.”
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Perreira v. Secretary of the Dept. of HHS, 33 F.3d 1375, 1377 (Fed. Cir.
1994). Dr. Vaughn asserts that “[o]ne of skill in the art knows that
pharmaceuticals are unique and [are] susceptible to water vapor and
oxidation to different degrees.” (Vaughn Declaration ¶ 15.) Dr. Vaughn
also states that “bacteria storage and pharmaceutical storage are not the same
and they are not interchangeable.” (Id.) Dr. Vaughn also states that it is a
“gross oversimplification of formulation technology” to assert that one can
equate storing organisms to storing pharmaceuticals “without testing any
pharmaceuticals.” (Id.) We do not find the foregoing persuasive of a lack of
motivation to combine the teachings of Mogna’s packaging with Liang’s
formulation of immediate release GHB combined with controlled release
GHB.
While it may be that pharmaceuticals are susceptible to water vapor to
a different degree than microorganisms, that fact does negate Mogna’s
teaching of a multilayer material as described above (see, e.g., Mogna
Tables 6 and 7 describing the invention as “Blister pack 2 multilayer
PVC/PP/EVOH/PP/PVC/material D PA/(AL)n/PE, n = 2) that has a
permeability to water vapor of less than 1 mg/L/24 hours and an oxygen
permeability of less than 1 cc/m3/24 hours (Mogna ¶ 70) and that can be
formed into a blister pack or sachet suitable for containing a diverse set of
components to protect the contents thereof from moisture and oxygen
degradation (¶¶ 6, 12, 13). That the breakdown of any pharmaceutical
stored within the packaging having the water and oxygen impermeability
described by Mogna has to be experimentally tested to assess how little of
the pharmaceutical was degraded does not establish a lack of motivation.
KSR, 550 U.S. at 417 (“if a technique has been used to improve one device,
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and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill.”).
[A]n implicit motivation to combine exists not only when
a suggestion may be gleaned from the prior art as a whole, but
when the “improvement” is technology-independent and the
combination of references results in a product or process that is
more desirable, for example because it is stronger, cheaper,
cleaner, faster, lighter, smaller, more durable, or more efficient.
Because the desire to enhance commercial opportunities by
improving a product or process is universal—and even common-
sensical— . . . there exists in these situations a motivation to
combine prior art references even absent any hint of suggestion
in the references themselves. In such situations, the proper
question is whether the ordinary artisan possesses knowledge and
skills rendering him capable of combining the prior art
references.
Dystar, 464 F.3d at 1368. To the extent that Dr. Vaughn suggests that one
of ordinary skill in the art is not capable of combining the art because GHB
“begins to deliquesce and spoil even before it can be sealed into the
packaging” and thus GHB “is clearly more unstable than the compounds
contemplated by Mogna and the Patent Office” (Vaughn Declaration ¶ 15),
we do not find that argument persuasive. Dr. Vaughn’s assertion that GHB
is more unstable than that which is “contemplated by Mogna” is not
supported by any factual evidence such as comparative testing to
demonstrate the comparative instability. Moreover, there is no factual
evidence demonstrating that the deliquescence of GHB before packaging
causes more instability than that of the microorganism exemplified in
Mogna, much less that the GHB formulation that is described by Liang is
subject to deliquescence prior to packaging.
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Dr. Vaughn also asserts that “early in experimentation” with GHB
some “experiment was tried and it failed.” (Vaughn Declaration ¶ 15.)
However, Dr. Vaughn’s testimony does not describe what the GHB
composition was that was being experimented with, nor does it describe
what materials the composition was being stored in. Consequently, it does
not establish that a formulation such as described by Liang was being
experimented with, or that the packaging described by Mogna was involved.
Thus, again, Dr. Vaughn’s testimony lacks the factual support necessary to
render it persuasive evidence of non-obviousness given the teachings of
Liang and Mogna.
Dr. Vaughn’s testimony that “there are numerous potential packaging
solutions to pharmaceuticals (film coating, desiccants, lyophilization), but
they are unpredictable as to which one might work for a particular API and
particular formulation” (Vaughn Declaration ¶ 15, see also id. ¶ 23
(comparing loss of potency of amoxicillin capsules in different blister packs
and stability of losartan/hydrochlorothiazide tablets in different blisters)) is
also not persuasive to evidence a lack of motivation for combining the
teachings of Liang’s composition with Mogna’s packaging teachings in light
of the discussion above regarding a reasonable expectation of success. The
“case law is clear that obviousness cannot be avoided simply by a showing
of some degree of unpredictability in the art so long as there was a
reasonable probability of success.” Pfizer, 480 F.3d at 1364.
As noted, we are not presented with a trial and error procedure that is
used to discover a new compound where the prior art gave no motivation or
suggestion to make the new compound nor a reasonable expectation of
success. Instead, we have a prior art teaching of packaging that can be used
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with a variety of active ingredients where the packaging provides a barrier to
water vapor of less than 1 mg/L/24 measured at 38 ºC and 90% relative
humidity and oxygen of less than 1 cc/m3/24 hours measured at 23 ºC and
100% relative humidity (see, e.g., Mogna ¶ 70) such that active ingredient
degradation by these components is inhibited significantly so as to provide
for a 24 month shelf-life of the packaged material (see, e.g., Mogna ¶ 12).
And a particular example of material used for packaging is provided, as well
as an example of the stability of an active agent, i.e., a microorganism,
within that packaging. (Id. ¶¶ 58–61, Tables 6–7.) Moreover, Liang
provides specific prototype examples of GHB controlled release and
immediate release formulations. Dr. Vaughn’s comparative evidence
asserting unpredictability of stability based on different packaging materials
with certain drug compound (i.e., amoxicillin and
losartan/hycrochlorothiazide tablets) in the declaration at paragraph 23 does
not appear to describe the packaging of any drug formulation in the blister
pack made with the materials exemplified in Tables 6–7 of Mogna, which
packaging is described by Mogna as the invention. Thus, the data in
paragraph 23 of Dr. Vaughn’s declaration does not establish unpredictable
results with respect to the inventive packaging of Mogna.
Consequently, for the reasons discussed, we conclude that there is
sufficient teachings in the prior art to provide a motivation to combine with a
reasonable expectation of success of achieving a package having a water
vapor transmission rate of less than 7 mg/liter/day, as required by the claim,
and thereby obtain a packaged pharmaceutical of the GHB composition of
Liang where no more than 0.4% GHB is converted to GBL under the
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claimed storage conditions, given that the PTO does not have the ability to
manufacture products or to do testing.
Dr. Vaughn attests to the fact that various container-closure systems
were tested and those having a water vapor transmission rate of less than 7
mg/liter/day stabilized the dissolution profile. (Vaughn Declaration ¶ 17.)
We find that testimony supports the Examiner’s conclusion that the stability
requirement of the claim would have been met with Mogna’s packaging,
which has a vapor transmission rate of equal to or less than 1 mg/liter/day.
Dr. Vaughn’s assertion that it is a “gross oversimplification of
formulation technology” to assert that one can equate storing organisms to
storing pharmaceuticals “without testing any pharmaceuticals” appears to
rest on a requirement of absolute predictability, rather than a reasonable
expectation of success. We conclude, for the reasons discussed above, that
the Examiner’s rejection provides cogent reasons to establish a reasonable
expectation of success. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d at 1364,
1367–69 (simply because the formation and properties of a new compound
must be verified through testing does not mean that the compound satisfies
the test for patentability “since the expectation of success need only be
reasonable, not absolute”). Dr. Vaughn’s testimony is based on
generalizations without providing sufficient factual evidence showing that
packaging having the limitations on permeability to water and oxygen as
described in Mogna and using the layers described as the invention in Tables
6 and 7 of Mogna would not have the same permeability characteristics with
other pharmaceuticals besides the exemplified probiotic bacteria placed
within the package.
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Appellant also argues that the fact the FDA and WHO have “rules in
place that the suitability of packing can only be ascertained through detailed
packaging and stability studies on the product concerned” (Appeal Br. 9–10)
supports a conclusion that one cannot predict the stability limitations
required by claim 1 based only on the teachings of Mogna and Liang. We
do not find this argument persuasive of non-obviousness. In particular, the
standard required to obtain approval to market a product by the FDA is not
the standard to assess patentability. The FDA, for example, requires specific
data of the product under review, including the stability of the product in the
packaging to be used commercially, to determine that the benefits of the
drug outweigh the risks of intended use. On the other hand, whether a
claimed invention is obvious from the prior art, only requires a reasonable
expectation of success of arriving at the claimed invention. Thus, that the
FDA requires stability testing of a drug product in the container system that
it is to be marketed in to demonstrate that the product is safe and effective to
be marketed, rather than allowing one to automatically assume one
packaging system that is suitable for one pharmaceutical product is
appropriate for another product, does not demonstrate that a skilled artisan
would not reasonably be expected to achieve the claimed invention in light
of the combined teachings of cited prior art. We have explained in detail the
reasons for such a reasonable expectation of success in light of the teachings
of Mogna and Liang, and Appellant has not provided a factual foundation
demonstrating unpredictability for different compounds with the packaging
of Mogna including with the Liang immediate release plus controlled release
GHB formulation. And for this reason, we do not find persuasive
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Appellant’s argument that evidence regarding the FDA and WHO has been
wrongfully dismissed by the Examiner (Appeal Br. 11–12.)
c. Evidence of Unexpected Results and Other Secondary
Considerations
Appellant argues that it has presented evidence of unexpected results
and long-felt need. (Appeal Br. 12, 14.) In particular, Appellant argues that
Dr. Vaughn, besides citing to FDA and WHO guidelines supporting
unexpected results, attested to the high level of storage stability being a
surprising and unexpected result for such a highly unstable drug as GHB.
(Id. at 14 (citing Vaughn Declaration ¶ 18).) Appellant also asserts that “the
composition which is an embodiment of the claimed invention has shown
unexpected results in its Phase 3 data during FDA clinical trials.” (Id. at 12.)
We do not find these arguments or the evidence support a conclusion
of non-obviousness. First, for the reasons already discussed, we do not find
the FDA or WHO guidelines to establish the claimed invention achieves
unexpected results. Second, Dr. Vaughn’s testimony that it is “surprising
and unexpected” that GHB, which is highly unstable, achieved a high level
of storage does not provide a factual foundation to explain why, given the
teachings of Mogna, such stability is unexpected, other than general and
broad based assertions of unpredictability, which we find unpersuasive for
the reasons discussed in section b., above.
Third, the evidence of long-felt need must be more than “long-felt
need in isolation”; rather, “[t]he relevant secondary consideration is ‘long-
felt but unsolved need.’” Monarch Knitting Machinery Corp. v. Sulzer
Morat GmbH, 139 F.3d 877, 884 (Fed. Cir. 1998). In other words, the
evidence should include unsuccessful attempts to solve the need. No such
evidence is provided here. Instead, Appellant’s evidence is that there is a
Appeal 2021-002713
Application 16/223,940

19
strong interest in a once-nightly sodium oxybate formulation and
formulation FT128 would address that interest. (Appeal Br. 12–13.) Not
only is this not evidence of unsuccessful attempts5 at providing a packaged
GHB formulation with the stability claimed, it is not even evidence
establishing a need for the packaged formulation. Instead, the proffered
evidence at most establishes a desire for a GHB formulation that can be
administered as a once nightly formulation.
Thus, for the reasons discussed above, we affirm the Examiner’s
rejection of claim 1 as being obvious over Liang and Mogna.
Claims 17–22 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Appellant contests the Examiner’s rejection of claims 10–15 because
“Dargelas does not cure the deficiencies of Liang and Mogna as references.”
(Appeal Br. 14.) We do not find there to be deficiencies of the teachings of
Liang and Mogna to render obvious claim 1. Consequently, we also affirm
the Examiner’s rejection of claims 10–15 as being obvious over Liang,
Mogna, and Dargelas.

5 We recognize Dr. Vaughn’s testimony that some experimentation was
tried and failed, thus allegedly disproving the Office’s assumption “that
packaging is both readily transferable and predictable based on a singular
common characteristic.” (Vaugh Declaration ¶ 15.) However, as we noted
already, no detail is provided regarding the experimentation that was done.
Thus, there is insufficient evidence from Dr. Vaughn’s bare statement to
demonstrate that others have tried and failed to provide a packaged GHB
composition as claimed that has the storage stability claimed.
Appeal 2021-002713
Application 16/223,940

20
Nonstatutory Double Patenting
Appellant does not contest the Examiner’s rejection of the claims for
nonstatutory double patenting. Nor has Appellant indicated a Terminal
Disclaimer has been filed. Accordingly, Appellant has presumptively
acquiesced to this rejection and we thus summarily affirm it. See MPEP
§ 1205.02 (“If a ground of rejection stated by the examiner is not addressed
in the appellant’s brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it, unless the examiner
subsequently withdrew the rejection in the examiner’s answer.”)
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 17–22 103 Liang, Mogna 1, 17–22
10–15 103 Liang, Mogna,
Dargelas
10–15
1, 10–15,
17–22
Nonstatutory
Double Patenting
1, 10–15,
17–22

Overall
Outcome
1, 10–15,
17–22

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