PAION UK LIMITED

Patent Trials and Appeals Board

Jun 17, 2021

2020006629 (P.T.A.B. Jun. 17, 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.
14/402,590 11/20/2014 John Aitken Graham ACAC-010N01US
322121-2045
2041
58249 7590 06/17/2021
COOLEY LLP
ATTN: IP Docketing Department
1299 Pennsylvania Avenue, NW
Suite 700
Washington, DC 20004
EXAMINER
MCDOWELL, BRIAN E
ART UNIT PAPER NUMBER
1624
NOTIFICATION DATE DELIVERY MODE
06/17/2021 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):
zIPPatentDocketingMailboxUS@cooley.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN AITKEN GRAHAM,
ALAN JAMES BAILLIE, KEVIN RICHARD WARD, and
THOMAS PEACOCK
____________

Appeal 2020-006629
Application 14/402,5901
Technology Center 1600
____________

Before JOHN G. NEW, RYAN H. FLAX, and
DAVID COTTA, Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a storage-
stable composition of methyl 3-[(4S)-8-bromo-1-methyl-6-(pyridine-2-yl)-
4H-imidazo [1,2-a] [1,4]benzodiazepin-4-yl]propanoate besylate. The
Examiner rejected the claims on appeal on under 35 U.S.C. § 103 as
obvious. We heard oral argument on June 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. According to Appellant, the real party in interest is Paion
UK Ltd. Appeal Br. 2.
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STATEMENT OF THE CASE
The Specification discloses that benzodiazepine compounds have
therapeutic uses including for “sedation or hypnosis, induction of anxiolysis,
induction of muscle relaxation, treatment of convulsions or induction and/or
maintenance of anesthesia.” Spec. 1. According to the Specification
“[p]roducts which are used as sedatives or anesthetic agents are normally
stored at room temperature.” Id. at 2. The Specification discloses that
“aqueous solutions” of benzodiazepine compounds lack “sufficient stability
at room temperature and show strong degradation within a short period of
time.” Id. In addition, the Specification discloses that lyophilization, a
“known technique for stabilizing water-labile compounds[,] . . . did not
result in satisfactory stability of . . . benzodiazepine.” Id. The Specification
thus asserts that there is “a need to provide formulations of short-acting
benzodiazepines, which exhibit sufficient stability at room temperature.” Id.
The Specification discloses that it was “an object of the present
invention to find pharmaceutically acceptable compositions with sufficient
stability at room temperature for short-acting benzodiazepines.” Id. The
Specification further discloses that “[t]he inventors have now found that
stable lyophilized formulations can be obtained, when mixtures of the
benzodiazepine with hygroscopic excipients are formulated and/or when the
lyophilized formulation is at least in part amorphous.” Id. at 2–3.
Claims 94–111 are on appeal. Claim 94 is representative and reads as
follows:
94. A storage-stable pharmaceutical composition of methyl
3-[(4S)-8-bromo-1-methyl-6-(pyridine-2-yl)-4H-imidazo [1,2-
a] [1,4]benzodiazepin-4-yl]propanoate besylate, consisting
essentially of (a) methyl 3-[(4S)-8-bromo-1-methyl-6-
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(pyridine-2-yl )-4H-imidazo[1,2-a] [1,4]benzodiazepin-4-
yl]propanoate besylate, (b) dextran having a molecular weight
of less than 80 kD and (c) lactose, wherein the pharmaceutical
composition is lyophilized and less than 1% of the carboxylic
ester moiety of the methyl 3-[(4S)-8-bromo-1-methyl-6-
(pyridine-2-yl)-4H-imidazo[l,2-a][l,4]benzodiazepin-4-
yl]propanoate is hydrolyzed after storage of the pharmaceutical
composition for at least 13 weeks at 25°C.
Appeal Br. 30.
The Examiner rejected claims 94–111 under 35 U.S.C. § 103(a) as
obvious over the combination of Feldman,2 Baheti,3 and Tilbrook.4
ANALYSIS
Appellant argues claims 94–111 together.5 Appeal Br. 6–28. We
designate claim 94 as representative.

2 Feldman et al., US Patent No. 7,160,880 B1, issued Jan. 9, 2007
(“Feldman”).
3 Ankit Baheti et al., Excipients Used in Lyophilization of Small Molecules,
1(1) J. Excipients and Food Chem. 41–54 (2010) (“Baheti”).
4 Tilbrook et al., WO 2008/007071 A1, published Jan. 17, 2008
(“Tilbrook”).
5 At oral argument, counsel for Appellant appeared to suggest that claims
requiring that dextran and/or lactose have a specific molecular weight or a
specific weight ratios were independently patentable. Tr. 3. However, this
argument is waived because it was not made in the appeal brief. 37 C.F.R.
§ 41.37(c)(1)(iv) (“Except as provided for in §§ 41.41, 41.47 and 41.52, any
arguments or authorities not included in the appeal brief will be refused
consideration by the Board for purposes of the present appeal.”). The
Appeal brief does include a brief discussion of the cited prior art in which
Appellant asserts that individual references do not disclose certain features
recited in the claims. See, e.g., Appeal Br. 8 (“There is no teaching in
Feldman regarding the weight % ratio of the lactose to the dextran in order
to prepare a storage-stable pharmaceutical composition comprising
remimazolam besylate.”). This is insufficient to raise the issue on appeal.
In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (holding that “[T]he
Board [has] reasonably interpreted Rule 41.37 to require more substantive
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In rejecting claim 94, the Examiner found that Feldman disclosed the
free base form of the claimed compound, methyl 3-[(4S)-8-bromo-1-methyl-
6-(pyridine-2-yl)-4H-imidazo [1,2-a] [1,4]benzodiazepin-4-yl]propanoate”
(“remimazolam”). Ans. 3. The Examiner further found that Feldman
“taught generically that pharmaceutically acceptable salts (including the
claimed besylate . . .) and lyophilized compositions thereof may readily be
prepared for these classes of compounds.” Id. at 3–4.
The Examiner found that Tilbrook included a similar disclosure that
“reinforces what is taught in Feldman.” Id. at 4. More particularly, the
Examiner found that Tilbrook disclosed that the free base form of
remimazolam was unstable at high temperature but that the besylate salt of
remimazolam “was readily isolated and showed good stability and low
hygroscopicity.” Id. The Examiner also found that Tilbrook suggested
lyophilized preparations and taught useful excipients to be used in the
lyophilized formulation.
Neither Feldman nor Tilbrook discloses the use of lactose and dextran
as claimed. To address this deficiency, the Examiner relies on Baheti. Id. at
4–5. The Examiner found that Baheti disclosed lactose and dextran among a
group of excipients commonly used in lyophilized formulations (id. at 5) and
taught that the listed excipients could be used alone or in combination (id. at
6). The Examiner concluded that using old excipients, like lactose and
dextran, was a “known improvement technique[] for getting a more useful
version of [a] pharmaceutical” and thus that “it would have been obvious to

arguments in an appeal brief than a mere recitation of the claim elements and
a naked assertion that the corresponding elements were not found in the
prior art.”).
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one of ordinary skill in the pharmaceutical art to have applied these known
improvement techniques . . . to [remimazolam].” Id. at 7–8.
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art and agree that the claims would have been
obvious over the combination of Feldman, Tilbrook, and Baheti. We
address Appellant’s arguments below.
Appellant argues that “Tilbrook taught that the besylate salt of
remimazolam had good stability in solid form as well as in multiple aqueous
solutions.” Appeal Br. 19. According to Appellant, “the cited art teaches
that stability issues of the free base can be solved by forming the besylate
salt” and thus there was “no reason or motivation for one of skill in the art to
‘solve’ the storage stability problem by combining Tilbrook with Baheti.”
Id. Appellant contends that the present claims are patentable because they
“solve a formulation problem not recognized in the art prior to its discovery
by the inventors.” Id.
We do not find this argument persuasive because the motivation to
include dextran and lactose in the composition suggested by Tilbrook and
Baheti need not be the same as inventors’ motivation in arriving at the
claimed composition. See Outdry Techs. Corp. v. Geox S.p.A., 859 F.3d
1364, 1370–71 (Fed. Cir. 2017) (“Any motivation to combine references,
whether articulated in the references themselves or supported by evidence of
the knowledge of a skilled artisan, is sufficient . . . . The motivation . . . need
not be the same motivation articulated in the patent for making the claimed
combination.”); PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1197
(Fed. Cir. 2014) (“[W]e are not limited to the same motivation that may have
motivated the inventors.”); Alcon Research, Ltd. v. Apotex Inc., 687 F.3d
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1362, 1368 (Fed. Cir. 2012) (“We have repeatedly held that the motivation
to modify a prior art reference to arrive at the claimed invention need not be
the same motivation that the patentee had.”).
Here, Feldman discloses the besylate salt of remimazolam as
“pharmaceutically acceptable” (Feldman, 51:31–42) and Tilbrook teaches
that “besylate salts . . . are easily isolated from a range of pharmaceutically
acceptable solvents and show good thermal stability, low hygroscopicity and
high aqueous solubility” (Tilbrook 2). In view of these disclosures, we
agree with the Examiner that the ordinary artisan would have found it
obvious to start with the besylate salt of remimazolam as a target for
optimization and development. Ans. 11.
Feldman also teaches that remimazolam “may be presented as
lyophilized solids for reconstitution with water (for injection) or dextrose or
saline solutions.” Feldman, 52:8–11. And Tilbrook teaches that a
“preferred formulation of a salt of [Tilbrook’s] invention is a lyophilized
formulation.” Tilbrook, 8. Together with Feldman’s and Tilbrook’s
teachings regarding the besylate salt, this supports that the ordinary artisan
would have found it obvious to use a lyophilized formulation of the besylate
salt of remimazolam.
We recognize that Feldman does not disclose excipients and Tilbrook
discloses different excipients than those recited in the present claims in their
lyophilized formulations. Feldman, 52:8–11 (disclosing that remimazolam
may be lyophilized without identifying excipients for use in lyophilized
compound); Tilbrook, 8 (disclosing a lyophilized formulation comprising “at
least one of the following agents: ascorbic acid, citric acid, malic acid,
phosphoric acid, glycine, glycine hydrochloride, succinic acid or tartaric
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acid”). However, Tilbrook also discloses that its formulation is not limited
to the excipients it lists, explaining that “[i]n some cases it may be beneficial
to include sodium chloride, mannitol, polyvinylpyrrolidone, or other
ingredients in the formulation.” Id. (emphasis added).
In addition, Baheti discloses that “[i]n the majority of lyophilized
formulations, excipients are included to improve the functional properties
and stability of the lyophilized product.” Baheti 42–43. According to
Baheti, “[e]xcipients also provide an aesthetic appeal to the product” and
“help[] in developing a robust and economical lyophilization process.” Id. at
43. Baheti classifies excipients by type and provides reason why each
category of excipient should be used in a lyophilized preparation. Id. at 43–
52. Figure 5 of Baheti, reproduced below, discloses a number excipients
commonly used in lyophilization. Baheti 46.
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Figure 5 is a “[c]lassification of commonly used excipients used in
lyophilization of small molecules.” Id. Figure 5 identifies dextran and
lactose among a group of 12 bulking agents. Other categories of excipients
identified in Figure 5 include buffering agents, solubilizing agents,
tonicifying agents, antimicrobial agents, and collapse temperature modifiers.
Id. In addition to the disclosure of Figure 5, Baheti discloses that
“[m]annitol and glycine, are the most commonly used bulking agents,
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followed by glucose, sucrose, lactose, trehalose and dextran.” Id. These
disclosures support that, absent a teaching to the contrary not present here, it
would have been obvious to include dextran and lactose in a lyophilized
formulation, like the lyophilized formulation of the besylate salt of
remimazolam suggested by Feldman and Tilbrook.
Appellant argues that Baheti offers too many choices to render the
selection of dextran and lactose non-obvious. Appellant explains:
Baheti offers 12 exemplary bulking agents among the classes.
Baheti also discloses buffering and pH adjusting agents, 15 in
total. Baheti also suggests the potential need for a solubilizing
agent such as complexing agents, 3 in total, possibly a
surfactant (1 listed), and possibly a co-solvent, offering 6 of
these. Among other possibly required agents to establish a
stabilized lyophilized product are tonicifying agents (4 in total),
antimicrobial agents (5), and collapse temperature modifiers
(indicating 4 such agents). See, Baheti at Figure 5. Nothing in
Baheti teaches or suggests the isolation of only one category of
agents to make a lyophilized formulation. The prior art
teaching must be taken as a whole, yet the Office has
overlooked the extremely broad scope of teaching, and lack of
specific guidance, in Baheti. Moreover, the present claims
include two bulking agents. Nothing in Baheti suggests
selecting more than one agent out of any one category. Armed
with nothing from the Baheti teachings, the combinations
become staggeringly large.
Appeal Br. 24. We do not find this argument persuasive.
The fact that Baheti discloses dextran and maltose as one among
twelve bulking agents and one among fifty excipients does not make their
use in the claimed lyophilized composition nonobvious. Sinclair & Carroll
Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945) (“Reading a list and
selecting a known compound to meet known requirements is no more
ingenious than selecting the last piece to put into the last opening in a jig-
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saw puzzle.”); see also Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804,
807 (Fed. Cir. 1989) (“That the ’813 patent discloses a multitude of effective
combinations does not render any particular formulation less obvious.”).
Absent evidence of unexpected results or criticality, we agree with the
Examiner that it would have been obvious to use lactose and dextran in a
lyophilized composition of remimazolam.
Appellant argues that the inventors “surprisingly discovered that
lyophilized formulations comprising the besylate salt of remimazolam and
dextran or lactose have significantly improved stability (as compared to [the]
besylate salt of remimazolam alone or with the excipients disclosed in
Tilbrook, i.e., mannitol, glycine and povidone).” Appeal Br. 21. Appellant
argues that as compared to Tilbrook’s formulations, “[t]he inventors
discovered that remimazolam besylate salt degradation was significantly
improved, with degradation rates less than 1% (Figure 4), when the
compositions comprise dextran or lactose.” Id. at 23. As support, Appellant
cites the Declaration of Luigi Moro. Id. (citing Moro Decl. ¶¶ 9–15).6
Mr. Moro testifies that the inventors tested 12 different formulations
of remimazolam, including formulations using three of the excipients
disclosed as being useful in lyophilized formulations in Tilbrook. Moro
Decl. ¶¶ 9–10. Mr. Moro presents the results of this testing in the below
table, which he reproduced from Figure 4 of the pending application.

6 Declaration of Luigi Moro Under 37 C.F.R. § 1.132, filed June 5, 2017
(“Moro Declaration” or “Moro Decl.”).
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Id. ¶ 11. According to Mr. Moro, the Figure 4 “indicates the percentage of
hydrolysis degradant of remimazolam (formed by hydrolysis of the ester
bond) that is present in the tested formulations of remimazolam after 13
weeks of storage at either 25°C and 60% relative humidity or at 40°C with
75% relative humidity.” Id. ¶ 12.
Mr. Moro testifies that Figure 4 shows that formulations of
remimazolam alone, and of remimazolam with mannitol, povidone, or
glycine resulted in undesirable high levels of degradation. Id. ¶ 13.
Mr. Moro asserts that these results were “not expected based on the specific
teachings of Tillbrook [sic] that useful lyophilized formulations of the
besylate salt of remimazolam could be made using mannitol, povidone and
glycine.” Id. Mr. Moro states that these results contrast with the results for
formulations of “remimazolam with either lactose, trehalose, sucrose,
maltose, or dextran at a 1:9 ratio [which were] able to keep hydrolysis
degradant levels at a desirable level of below 1% at both tested temperatures
and humidity levels.” Id. ¶ 14. According to Mr. Moro, these results are
“unexpected based on the disclosures of . . . Baheti . . . which . . . discloses
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mannitol, lactose, sucrose, trehalose, glycine and dextran as interchangeable
‘bulking agents.’” Id. ¶ 15. We are not persuaded.
As an initial matter, with the exception of formulation # 10 (which is
directed to a formulation of remimazolam, lactose, and mannitol), the data in
Figure 4 above is directed to remimazolam alone or with specific amounts of
individual excipients. Id. ¶ 11. Consistent with the data, the arguments in
Appellant’s Appeal Brief are worded to encompass the alleged superiority of
individual excipients rather than the claimed combination of excipients. See,
e.g., Appeal Br. 21 (“[T]he inventors surprisingly discovered that
lyophilized formulations comprising the besylate salt of remimazolam and
dextran or lactose have significantly improved stability (as compared to
besylate salt of remimazolam alone or with the excipients disclosed in
Tilbrook, i.e., mannitol, glycine and povidone).”) (emphasis added), 23
(“The inventors discovered that remimazolam besylate salt degradation was
significantly improved, with degradation rates less than 1% (Figure 4), when
the compositions comprise dextran or lactose.”) (emphasis added). Because
Appellant’s evidence and argument is not commensurate with the scope of
claim 94, which requires a composition consisting essentially of unspecified
quantities of remimazolam, dextran, and lactose, it is not persuasive of
unexpected results. In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir.
2011) (“Evidence of secondary considerations must be reasonably
commensurate with the scope of the claims.”); In re Harris, 409 F.3d 1339,
1344 (Fed. Cir. 2005) (“Even assuming that the results were unexpected,
Harris needed to show results covering the scope of the claimed range.”).
At oral argument, Appellant’s counsel pointed us to data in the
Specification regarding a formulation comprising remimazolam, dextran,
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and lactose. Tr. 5, 7. However, the Appeal Brief does not include argument
based on this data. See generally Appeal Br. The Moro Declaration makes
reference to this data, but argument based on this testimony is waived
because the Appeal Brief does not cite this portion of the Moro Declaration.
37 C.F.R. § 41.37(c)(1)(iv). Even if we were to consider Mr. Moro’s
testimony on this point, Mr. Moro does not testify that the claimed
combination of excipients demonstrates unexpected stability as compared to
any other composition, but only that the data shows that the claimed
composition is “desirable and stable, and suitable for use via injection.”
Moro Decl. ¶ 19. This is particularly significant given that several of the
individual excipients identified in Figure 4 appear to demonstrate stability
properties well within those recited by the claim – i.e., “less than 1% of the
carboxylic ester moiety . . . is hydrolyzed after storage of the pharmaceutical
composition for at least 13 weeks at 25ºC.” See id. ¶ 11 (showing
formulations of remimazolam with just lactose, trehalose, sucrose, maltose,
dextran, and povidone as having the stability recited in the wherein clause of
claim 94); see also Tr. 7 (oral argument where counsel for Appellant was
asked to speak to the issue that individual excipients performed similarly to
the claimed combination of excipients and counsel acknowledged that “with
certain molecular weights of dextran, you can get pretty decent results as
well”). Accordingly, the current record does not support that the
formulation recited in claim 94 demonstrates unexpectedly superior stability.
In the Reply Brief, Appellant argues that the Examiner failed to
consider evidence that a formulation of remimazolam, dextran, and lactose
exhibited a reduced time for reconstitution as compared to a formulation of
just remimazolam and dextran. Reply Br. 3 (citing Moro Decl. ¶¶ 17, 18).
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We do not consider this argument because it was not presented in the Appeal
Brief, thus depriving us of the Examiner’s response. 37 C.F.R.
§ 41(c)(1)(iv). Even if we were to consider this argument, we would not
find it persuasive of unexpected results because the evidence presented is
directed to a single formulation comprising specific amounts of
remimazolam, dextran, and lactose (Moro Decl. ¶ 17), and Appellant does
not direct us to persuasive evidence that this specific formulation is
representative of all of the quantities of remimazolam, dextran, and lactose
encompassed by claim 94.
Appellant argues that Baheti demonstrates that there is
unpredictability among the performance of the excipients it discloses.
Appeal Br. 26. For example, Appellant points to Baheti’s teachings that: 1)
“for a particular compound, cyclophosphamide, mannitol performed better
than lactose,” 2) the bulking agent may crystallize after lyophilization and
that such crystallization “might adversely affect the stability of the product,”
3) “methylprednisolone sodium succinate provided a less stable product with
mannitol than lactose,” and 4) “the bulking agent may crystallize into
different polymorphic forms which ‘could also have serious implications on
physical stability.’” Id. We are not persuaded.
“[The] 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, Inc. v. Apotex, Inc., 480 F.3d
1348, 1364 (Fed. Cir. 2007) (finding besylate salt of known compound
obvious even though “it was generally unpredictable as to whether a
particular salt would form and what its exact properties would be”
explaining that if the law were to the contrary “any new salt . . . would be
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separately patentable, simply because the formation and properties of each
salt must be verified through testing”). Here, Baheti teaches that dextran
and lactose are among “the most commonly used bulking agents” in
lyophilized formulations. Baheti, 46. Mr. Moro describes Baheti as
“disclos[ing] mannitol, lactose, sucrose, trehalose, glycine and dextran as
interchangeable ‘bulking agents.’” Moro Decl. ¶ 15. We find that Baheti’s
teaching of differences in the performance of individual excipients, and of
potential issues regarding crystallization of bulking agents, is insufficient to
undermine the reasonable expectation of the ordinary artisan that including
commonly used bulking agents, like lactose and dextran, in a lyophilized
formulation of the besylate salt of remimazolam would be successful.
Appellant argues that Baheti discloses that “control of pH is critical to
avoid degradation,” and thus it is “surprising that the present claims do not
encompass the use of a pH control agent as the formulation consists
essentially of the besylate salt of remimazolam with lactose and dextran, but
no pH control agent.” Appeal Br. 26. We are not persuaded.
The phrase “consisting essentially of” is used to signal a partially
open claim in a patent. PPG Indus. v. Guardian Indus. Gorp., 156 F.3d
1351, 1354 (Fed. Cir. 1998). A claim using the phrase “consisting
essentially of” is generally understood to encompass the components that
follow the transitional phrase as well as additional unlisted ingredients that
do not “materially affect the basic and novel properties of the invention.” Id.
Appellant argues, implicitly, that the addition of a pH control agent would
materially affect the basic and novel properties of the claimed composition.
Appeal Br. 26.
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We turn to the Specification for guidance. As an initial matter, the
Specification does not identify any components as being excluded from the
claimed supplement nor does it define what constitutes a “material change”
in the properties of the composition. See PPG Indus., 156 F.3d at 1355
(noting that the patentee “could have defined the scope of the phrase
‘consisting essentially of’ for purposes of its patent by making clear in its
specification what it regarded as constituting a material change in the basic
and novel characteristics of the invention”). The Specification does provide
some guidance as to what the inventors considered to be the novel properties
of the claimed invention in its discussion of the problems solved. It teaches
that “there is a need to provide formulations of short-acting benzodiazepines,
which exhibit sufficient stability at room temperature.” Spec. 2. Appellant
solved the problems in the art by using lyophilized formulations of
“mixtures of the benzodiazepine with hygroscopic excipients.” Id.
Accordingly, we find that the basic and novel properties of the claimed
composition are that it exhibits sufficient stability at room temperature.
Having identified the alleged basic and novel properties of
Appellant’s composition, we next address Appellant’s argument that the
claims exclude a pH control agent. Baheti teaches that “[c]ontrol of pH is
critical to avoid degradation of drug during processing, storage, and
reconstitution, thereby necessitating [the] addition of [a] buffering agent in
the lyophilized formulation.” Baheti 49. This suggests that the addition of a
buffer can materially impact the stability of a lyophilized composition.
However, according to Appellant, the claimed composition is already stable
at room temperature. Appellant does not provide persuasive evidence that
the addition of a pH control agent would materially affect the room-
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temperature stability of an already storage-stable composition or, more
specifically, the stability of the claimed composition. Accordingly, we are
not persuaded by Appellant’s argument that the claims exclude the addition
of a pH control agent.
For the reasons discussed above, we affirm the Examiner’s rejection
of claim 94 over the combination of Feldman, Baheti, and Tilbrook.
Because they were not argued separately, claims 95–111 fall with claim 94.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
94–111 103(a) Feldman, Baheti,
Tilbrook

94–111

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