Ex Parte Lindberg et al

Board of Patent Appeals and Interferences

Nov 25, 2009

10634159 (B.P.A.I. Nov. 25, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte NILS-OLOF LINDBERG,
KATARINA LINDELL, KRISTINA THYRESSON, and
ALICE C. MARTINO
__________

Appeal 2009-0036471
Application 10/634,159
Technology Center 1600
__________

Decided: November 25, 2009
__________

Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to compositions
for treating sexual dysfunction. The Examiner has rejected the claims as
obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 McNeil AB is the Real Party in Interest (App. Br. 2).
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STATEMENT OF THE CASE
Claims 1, 3-6, 13, 14, 21-23, 25-31, 47-50, and 54 stand rejected and
appealed (App. Br. 2, 16-19).2 Claim 1 is representative and reads as
follows:
1. A sexual dysfunction compound-containing
composition comprising cocoa powder as a vehicle and taste-
masking agent in an amount of at least 50% wherein the cocoa
powder is not present as an ingredient in chocolate and wherein
the composition does not comprise a chewing gum and the
composition is capable of being orally administered for
immediate absorption leading to rapid onset of therapeutic
effect and wherein the composition disintegrates and/or melts at
body temperature without the aid of salivary fluid or
mechanical erosion or a combination thereof.

The Examiner cites the following documents as evidence of
unpatentability:
Gmunder US 2002/0012633 A1 Jan. 31, 2002
Girsh US 6,197,356 B1 Mar. 6, 2001
Chandrakumar US 5,604,220 Feb. 18, 1997
Martani WO/9524890 A1 Sep. 21, 1995
(abstract only)

Sildenafil Citrate 25-mg Sublingual Troches, 3 INTERNATIONAL
JOURNAL OF PHARMACEUTICAL COMPOUNDING 135 (March/April 1999)
(hereinafter “IJPC”).

The sole ground of rejection on appeal is the Examiner’s rejection of
claims 1, 3-6, 13, 14, 21-23, 25-31, 47-50, and 54 under 35 U.S.C. § 103(a)

2 Page 2 of the Appeal Brief does not list claims 25-27 as being appealed.
That omission appears to be inadvertent, however, as those claims are
among those listed in the Claims Appendix (App. Br. 17-18), are listed in
Reply Brief as rejected (Reply Br. 3), and are also among the claims rejected
by the Examiner (Ans. 4).
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as being unpatentable over the IJPC, Gmunder, Martani, Chandrakumar, and
Girsh (see Ans. 3-18).
OBVIOUSNESS
ISSUE
The Examiner cites the IJPC as disclosing “sublingual troches
containing sildenafil citrate including carriers such as polyethylene glycol[,]
a flavoring[,] and a sweetener such as aspartame” (Ans. 4-5). The Examiner
notes that the flavoring is listed as being present in a “qs” or “sufficient
quantity” (id. at 5).
The Examiner concedes, however, that the IJPC does not disclose the
presence or amount of cocoa powder required by the claims (id. at 6). To
meet those features the Examiner cites Gmunder as using a chewing gum
vehicle to deliver sildenafil to patients through the oral mucosa, the gum
including a flavoring agent, which may be cocoa powder, to mask the
medication’s unpleasant taste (id. at 6-7). The Examiner also cites the
abstract of Martani as further evidence that cocoa powder was known in the
art as a pharmaceutical taste-masking agent (id. at 8).
The Examiner also concedes that “it is not specifically known if the
composition of IJPC would melt at body temperature without the aid of
salivary fluid or mechanical erosion or a combination thereof” (id. at 12).
The Examiner finds that “[c]ocoa butter however, is a suitable carrier for
sublingual pharmaceutical compositions which does melt at body
temperature absent the aid of saliva” (id. at 13). The Examiner further finds
that Chandrakumar discloses cocoa butter and polyethylene glycol as being
interchangeable carriers in buccal and sublingual suppositories (id. at 8).
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Based on these teachings, the Examiner concludes that an ordinary
artisan would have considered it obvious to “substitute cocoa butter for the
polyethylene glycol as described by IJPC because cocoa butter would have
performed the same carrier function as polyethylene glycol, however cocoa
butter would have had the additional advantage of imparting even more
flavor to the troche taught by IJPC” (id. at 13-14). The Examiner further
concludes that an ordinary artisan would have considered it obvious to add
lecithin to the IJPC’s composition in view of Girsh’s disclosure that lecithin
enhances delivery of therapeutic agents to the buccal and sublingual mucosa
(id. at 8-9, 14-15).
Appellants contend that the Examiner failed to make a prima facie
case of obviousness (see App. Br. 5). Specifically, Appellants argue, given
the disparate teachings of the IJPC, Gmunder, and Martani, an ordinary
artisan would not have arrived at the claimed composition by combining
these references’ disclosures (id. at 6-8).
Moreover, Appellants urge, Chandrakumar does not demonstrate that
polyethylene glycol (PEG) and cocoa butter are interchangeable carriers for
buccal or sublingual formulations (id. at 9), and even if they were, an
ordinary artisan would not have been prompted to substitute cocoa butter for
the IJPC’s PEG carrier, given the IJPC’s disclosure that sildenafil citrate’s
absorption is slowed by fatty meals (id. at 11). Appellants further argue that
Girsh does not remedy the deficiencies of the other references because Girsh
teaches that cocoa butter is a lipid, which, as shown by the IJPC, would be
undesirable in sublingual sildenafil citrate formulations (id. at 13).
Appellants argue further that the dependent claims would also have been
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unobvious over the cited references in view of the IJPC’s teaching against
including lipids in its formulation (id. at 11).
Appellants conclude therefore that the combination of references
advanced by the Examiner “would render the prior art unsuitable for its
intended purpose, the alleged equivalents are not equivalent in practice, and
the required reasonable expectation of success is absent. Thus, a finding of
obviousness is precluded and the rejection must be overturned” (id. at 13-
14).
In arguing this rejection, Appellants only separate the independent
claims from the dependent claims (see id. at 11). We select claims 1 and 3
as representative of the rejection. See 37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by the Examiner and Appellants,
the issue with respect to this rejection is whether the Examiner erred in
concluding that one of ordinary skill would have considered claims 1 and 3
prima facie obvious in view of the combined teachings of the IJPC,
Gmunder, Martani, Chandrakumar, and Girsh.
FINDINGS OF FACT (“FF”)
1. Claim 1 recites a composition that contains a sexual dysfunction
compound. Claim 1 specifies that the composition does not contain a
chewing gum, and that the composition can be orally administered for
immediate absorption leading to rapid onset of therapeutic effect.
Claim 1 also requires the composition to also contain cocoa powder as
a vehicle and taste-masking agent in an amount of at least 50%. Claim 1
specifies that the cocoa powder is not present as an ingredient in chocolate.
2. “Chocolate is defined as a product obtained from cocoa nib, cocoa
mass powder and sucrose with or without added cocoa butter, having a
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minimum dry cocoa solids content of 35%, at least 14% of dry non-fat cocoa
solids and 18% cocoa butter” (Spec. [0086]).
3. Claim 1 also specifies that “the composition disintegrates and/or melts
at body temperature without the aid of salivary fluid or mechanical erosion
or a combination thereof.”
4. Each of Appellants’ exemplified compositions contains, at least, a
sexual dysfunction compound, cocoa powder, a buffer, a sweetener, and
“cocoa butter equivalents” combined with a lecithin emulsifier as the lipid
ingredient (Spec. [0097], [0100]).
The Specification does not explicitly test or demonstrate that any of
the exemplified compositions meet the disintegration/melting functional
limitation. However, the Specification discloses that Appellants’
compositions can contain cocoa butter as the lipid ingredient (id. at [0089],
[0106]) and lecithin as the emulsifier ([0100], [0109]).
Appellants do not dispute that using cocoa butter as a lipid ingredient
in combination with other exemplified ingredients yields a composition that
meets the disintegration/melting functional limitation.
5. The IJPC discloses that “Sildenafil citrate (Viagra TM) is available
only in an oral swallow-tablet dosage form . . . [which] is rapidly absorbed
upon oral administration but is only about 40% bioavailable . . . . The
maximum observed plasma concentrations are attained within 30 to 120
minutes (median, 50 minutes)” (IJPC 135). The IJPC discloses, however,
that if sildenafil is taken “with a high-fat meal, the absorption is delayed”
(id.).
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6. The IJPC discloses that, “[f]or those patients desiring a more rapid
onset of action, a decrease in the dose needed and an easy method to change
the dose, the sildenafil citrate sublingual troche is an option” (id.).
7. In addition to the sildenafil, the troches disclosed by the IJPC contain
aspartame, silica gel, acacia, PEG 1450, and flavor (id.). The flavor
ingredient is described as being present in a “qs” amount, which is
undisputed as meaning a quantity sufficient (id.).
8. The IJPC states that PEG 1450 “occurs as white or off-white waxy
flakes or powder with a melting point of about 44 to 48°C” (id.).
9. The sublingual troches are prepared in the IPJC by combining all of
the ingredients except the PEG and flavor into a fine powder mix, melting
the PEG, adding the mixed ingredients and flavor to the liquefied PEG,
pouring the mixture into troche molds, and allowing them to cool (id.).
10. Gmunder discloses “chewing gum formulations for delivering a
medicament, namely sildenafil citrate, to an individual” (Gmunder, abstract).
11. Gmunder discloses:
[A]s the chewing gum composition is chewed, the
medicament is gradually released from the composition and
into the saliva of the oral cavity. During continual chewing, the
medicament in the saliva is then forced due to the pressure
created by the chewing action through the oral mucosa of the
oral cavity into the systemic circulation via the buccal or
sublingual absorption routes. The oral mucosa has a thin
epithelium and a rich vascularity. Thus, the oral mucosa favors
rapid drug absorption. In contrast to a typical orally ingested
drug wherein the solution is in contact too briefly with the oral
mucosa for absorption to be appreciable, it is believed that
during chewing, the agent and/or medicament remains in
contact with the oral cavity for a longer period of time and is
forced through the oral mucosa to a larger extent.

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(Id. at [0042].)
12. Gmunder discloses that its gum can be in the form of a “a single
piece, for example, a stick, slab, or other unitary structure,” or “the sildenafil
can be located within a coating or shell that substantially encloses a gum
center” (id. at [0053]-[0054]).
13. Regarding the coated gums, Gmunder discloses:
In addition to the sildenafil, the coating can include a masking
agent to improve the taste of the coating containing the
sildenafil. A variety of masking agents can be utilized
including: sucralose; zinc gluconate; ethyl maltol; glycine;
acesulfame-k; aspartame; saccharin; fructose; xylitol; spray
dried licorice root; glycerrhizine; dextrose; sodium glutonate;
glucono deltalactone; ethyl vanillin; vanillin; normal and high
potency sweeteners; and a variety of appropriate flavors. A
sufficient masking agent is used to mask the taste of the
sildenafil.

(Id. at [0054].)
14. Gmunder discloses that, generally, “a chewing gum typically
comprises a water-soluble bulk portion, a water-insoluble chewable gum
base portion, and a flavoring agent. The water-soluble portion dissipates
with a portion of the flavoring agent over a period of time during chewing.
The gum base portion is retained in the mouth throughout the chew” (id. at
[0058]).
15. Gmunder discloses:
[T]he flavoring agent of the present invention should be capable
of masking the unpleasant taste sensation associated with
sildenafil citrate. In doing so, the flavoring agent increases the
contact time of the chewing gum composition of the present
invention in the oral cavity. In doing so, the chewing gum
composition enhances the absorption and bioavailability of the
sildenafil citrate component and prolongs the drug’s therapeutic
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effects by gradually releasing the agent from the chewing gum
composition.

(Id. at [0076].)
16. Gmunder discloses that the flavoring agent can constitute about 0.1 to
about 15% by weight of the gum, “and preferably, about 0.2% to about 5%
by weight. . . . Natural and artificial flavoring agents such as cocoa powder
and heat-modified amino acids can be used as a flavoring agent within the
present invention, and may be combined in any sensorially acceptable
fashion” (id. at [0077]).
17. Martani discloses:

A method for preparing chewable tablets in which the
active ingredient is selected from the group which includes
troxerutine, calcium carbonate, calcium phosphate, arginine
aspartate, arginine glutamate, amoxicillin, a combination of
calcium carbonate and magnesium carbonate, and a
combination of aluminium hydroxide and magnesium
hydroxide, wherein an effective amount of cocoa powder acting
as the flavour-masking agent and compression agent is
incorporated into the tablet.

(Martani, abstract.)
18. Chandrakumar discloses “substituted dibenzoxazepine compounds . . .
which are useful as analgesic agents for the treatment of pain”
(Chandrakumar, abstract).
19. Chandrakumar discloses that its compounds can be supplied in
“pharmaceutical compositions . . . specially formulated for oral
administration in solid or liquid form, for parenteral injection, or for rectal,
sublingual, transdermal or vaginal administration” (id. at col. 7, ll. 14-17).
20. Chandrakumar discloses:
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Formulations of the pharmaceutical compositions of the
invention for rectal, sublingual or vaginal administration may
be presented as a suppository, which may be prepared by
mixing one or more compounds of the invention with one or
more suitable nonirritating excipients or carriers comprising,
for example, cocoa butter, polyethylene glycol, a suppository
wax or a salicylate, and which is solid at room temperature, but
liquid at body temperature and, therefore, will melt in the
rectum or vaginal cavity and release the active compound.

(Id. at col. 14, ll. 30-39.)
21. Girsh discloses “a method for reducing the allergenicity of a food
comprising treating the food with a super critical fluid or critical liquid gas”
(Girsh, col. 2, ll. 49-51).
The invention also provides a composition for the oral
delivery of a medicament or vitamin comprising the
medicament or vitamin and a vehicle comprising fat, wherein
the fat includes a phospholipid in the amount of from about
0.1% to about 0.6% based upon the total vehicle weight. In a
preferred embodiment the composition further comprises a low
molecular weight and low caloric density fat. In a most
preferred embodiment the vehicle further comprises a
sweetener and cocoa powder which has been treated with a
super critical fluid or critical liquid gas.

(Id. at col. 3, ll. 48-57.)
22. Girsh discloses that “[i]t has been unexpectedly discovered that
phospholipid emulsifiers, and in particular phosphatidylcholine, can be used
to enhance delivery to the oral mucosa, particularly the buccal and
sublingual mucosa” (id. at col. 19, ll. 5-8).
23. Girsh discloses:
A vehicle comprising fat, wherein the fat includes a
phospholipid (preferably from about 30 to about 100% by
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weight of phosphatidylcholine), can be used for the oral
delivery, via oral (including sublingual and pharyngeal) mucosa
contacted by prolonged taste savoring, of fat soluble
medicaments such as acetylsalicylic acid and acetaminophen,
and vitamins. The delivery of water soluble medicaments and
vitamins can also be enhanced by high phosphatidyl choline
phospholipids. A synergistic effect is obtained when the
vehicle further comprises a low molecular weight (particularly
containing C2 fatty acid) and low caloric density fat such as
Salatrim. The vehicle may further comprise a sweetener and
cocoa powder which has been treated with a super critical fluid
or critical liquid gas.

(Id. at col. 19, ll. 12-25.)
24. Girsh discloses that “phospholipids useful as fat emulsifiers include,
for example, phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl
serine, and phosphatidyl inositol. The phospholipids are preferably derived
from lecithin, preferably soy lecithin, which is conventionally used in
chocolate products” (id. at col. 18, ll. 32-37).
25. Girsh discloses that “[i]t has also been unexpectedly discovered that
cocoa butter which has been minimally or non-deodorized retains its own
lecithin” (id. at col. 18, ll. 42-44).
26. Girsh discloses that, in one embodiment, the fat portion of its oral
mucosa delivery system include “25 to 45 micron spherical particles . . . best
formed in a beta crystalline fat system such as the confectionary fats which
are primarily soy, soy cottonseed, tempered cocoa butter, palm, Shea or
Illipe fat as well as lauric fats including cocoanut and palm kernel oil” (id. at
col. 19, ll. 56-60).
27. The Specification states:
European Patent Application No. 0 960 621 discloses that
sildenafil citrate has an unpleasant taste that cannot be
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completely masked by flavoring agents, and proposes rapidly
disintegrating oral dosage forms of sildenafil in the form of its
free base, which has extremely low solubility in water and is
virtually tasteless.

(Spec. [0010].)
PRINCIPLES OF LAW
In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme
Court reaffirmed that, under the controlling inquiry for obviousness, “the
scope and content of the prior art are to be determined; differences between
the prior art and the claims at issue are to be ascertained; and the level of
ordinary skill in the pertinent art resolved,” and that “[s]uch secondary
considerations as commercial success, long felt but unsolved needs, failure
of others, etc., might be utilized to give light to the circumstances
surrounding the origin of the subject matter sought to be patented.” Id. at
406 (quoting Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18
(1966)). The Court stated that “[i]f a court, or patent examiner, conducts
this analysis and concludes the claimed subject matter was obvious, the
claim is invalid under § 103.” KSR, 550 U.S. at 407.
The Court advised that the analysis under 35 U.S.C. § 103 “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; see
also id. at 421 (“A person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.”).
Applying these concepts, the Court ultimately reaffirmed “that when a
patent ‘simply arranges old elements with each performing the same
function it had been known to perform’ and yields no more than one would
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expect from such an arrangement, the combination is obvious.” Id. at 417
(quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976)). The Court
reasoned:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 421.
It is well settled that “the discovery of an optimum value of a variable
in a known process is usually obvious.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal
parameters for prior art result effective variables “flows from the ‘normal
desire of scientists or artisans to improve upon what is already generally
known.’” Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed.Cir.2003)).
ANALYSIS
Appellants’ arguments do not persuade us that the Examiner failed to
make a prima facie case of obviousness with respect to claim 1. Appellants
concede that “[i]n this case, neither the level of ordinary skill in the art, nor
secondary consideration[s] are at issue” (App. Br. 5).
Rather, Appellants urge, thorough consideration of the scope and
content of the prior art, and the differences between the prior art and the
claims, demonstrates the claims’ unobviousness (id.). We do not agree.
The sublingual composition disclosed by the IJPC differs from the
composition of claim 1 in three respects. First, the IJPC’s composition does
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not contain cocoa powder. Second, the cocoa powder is not present in an
amount of at least 50%. Third, based on the about 44 to 48°C melting point
of the PEG 1450 used as a carrier, the IJPC’s composition was not found by
the Examiner to be capable of disintegrating and/or melting at body
temperature without the aid of salivary fluid or mechanical erosion or a
combination thereof (see FF 8; Ans. 12-13).
Regarding the cocoa powder, however, the IJPC states that its
compositions should contain a flavoring in a sufficient amount (FF 7). As
the Examiner points out, Gmunder discloses that cocoa powder is a flavoring
that is suitable for masking the unpleasant taste of sildenafil citrate in
chewing gum compositions intended to allow absorption of the drug through
the oral mucosa (FF 15-16).
Given Gmunder’s teaching of the suitability of cocoa powder as a
taste-masking agent in sildenafil citrate compositions, we agree with the
Examiner that an ordinary artisan would have been prompted by Gmunder to
use cocoa powder as a flavor in the IJPC’s composition. Moreover, an
ordinary artisan viewing the IJPC’s teaching that the flavor should be
present in a “sufficient” amount, rather than any precise proportion, would
have reasoned that the quantity of the flavor ingredient in the IJPC’s
composition was a result effective variable that was routinely optimized by
those of ordinary skill. Thus, a preponderance of the evidence supports the
Examiner’s conclusion that an ordinary artisan would have considered the
amount of cocoa powder recited in claim 1 obvious, absent something
unexpected resulting from the claimed concentration of the flavor.
As noted above, the IJPC’s composition also differs from claim 1 in
that the IJPC’s compositions was not found to have met the functional
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limitation requiring the composition to be capable of disintegrating and/or
melting at body temperature without the aid of salivary fluid or mechanical
erosion or a combination thereof. However, as discussed above, and when
viewed in light of the Specification, this limitation would be met by
substituting cocoa butter for the PEG 1450 in the composition disclosed by
the IJPC (see FF 3-4).
As the Examiner points out, Chandrakumar discloses that cocoa butter
is known in the art as a carrier in pharmaceutical compositions, including
sublingual compositions, which are solid at room temperature, but which
melt at body temperature, allowing release of the therapeutic compound into
the appropriate body cavity (FF 20). Girsh bolsters the Examiner’s prima
facie case by disclosing that water-soluble and water-insoluble medicaments
can be delivered to oral mucosa, including sublingual mucosa, using fat-
containing vehicles which can include cocoa butter in the fat vehicle, and
which include phospholipids, such as lecithin (FF 23-26), the same mixture
of lipids used in Appellants’ compositions (see FF 4).
Girsh provides additional impetus for including cocoa butter in
sublingual formulations by disclosing that cocoa butter can contain lecithin,
which is useful in such formulations (FF 25). Girsh also provides additional
impetus for including cocoa powder in sublingual formulations by disclosing
the desirability of cocoa powder in its fat-carrier-containing sublingual
formulations (FF 23).
Thus, we agree with the Examiner that an ordinary artisan viewing
these teachings in Chandrakumar and Girsh would have reasonably inferred
that a fat-based vehicle including cocoa butter would be a suitable carrier for
a sublingual composition such as that disclosed by the IJPC, and would
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therefore have been prompted to substitute a cocoa butter-based carrier for
the PEG 1450 vehicle used by the IJPC. Accordingly, we agree with the
Examiner that an ordinary artisan would have considered it obvious to
formulate the IJPC’s sublingual sildenafil composition such that it
“disintegrates and/or melts at body temperature without the aid of salivary
fluid or mechanical erosion or a combination thereof,” as required by claim
1.
As discussed above, we further agree with the Examiner that an
ordinary artisan would have been prompted to include cocoa power in the
IJPC’s composition in the amount recited in claim 1. Because the prior art
suggests using the claimed flavoring in the claimed amount in the IJPC’s
sublingual composition, and also suggests using, in sublingual compositions,
a carrier that would impart the claimed functional properties to the
composition, we are not persuaded that the Examiner erred in finding claim
1 prima facie obvious over the cited references.
Claim 3 recites “[t]he sexual dysfunction compound-containing
composition of claim 1, further comprising one or more lipid ingredients.”
As cocoa butter is a lipid (see, e.g. FF 26), the combination of references
advanced by the Examiner also meets the limitations of claim 3.
We note, as Appellants argue, that the IJPC does not explicitly state
the purpose for which its flavoring must be sufficient. We also note that
Gmunder is directed to a gum formulation, which is intended to produce a
relatively gradual release and absorption of the sildenafil, through extended
presence of the gum in the mouth (FF 11, 15), whereas the IJPC is directed
to a sublingual formulation intended for rapid absorption to produce rapid
onset of therapeutic effect (FF 6). We further note that Gmunder does not
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teach cocoa powder as being among the taste masking agents used in the
gum formulation’s coating (FF 13).
However, Gmunder does in fact disclose that sildenafil citrate has an
unpleasant taste which can be masked by including a flavoring, which can be
cocoa powder, in its base gum formulation (FF 14-16). Given the IJPC’s
disclosure that its sublingual compositions should contain flavors, we are not
persuaded that an ordinary artisan would have failed to consider Gmunder’s
cocoa powder a suitable flavoring for the IJPC’s composition, nor are we
persuaded that an ordinary artisan would have lacked the capacity to
determine how much cocoa powder to include to make the formulation
suitably palatable for sublingual administration.
We note the Specification’s statement that at least one prior art patent
considered the taste of sildenafil citrate as being so unpleasant as to be
incapable of masking with flavor agents (FF 27). It is unclear on this record
however, what tests, using which flavorings, in which amounts, were
performed to draw this conclusion. We are therefore not persuaded that
Appellants have adduced sufficient evidence to undermine Gmunder’s
disclosure regarding the suitability of flavorings in orally absorbed sildenafil
citrate compositions, or the reasonable expectation that including cocoa
powder in the IJPC’s sublingual formulation would mask the unpleasant
taste of sildenafil citrate. Nor are we persuaded that Gmunder’s disclosure is
undermined by Martani’s failure to include sildenafil citrate among
medicaments suitably combined with cocoa powder.
We note the IJPC’s disclosure that absorption of sildenafil citrate is
slowed by a fatty meal (FF 5). We are not persuaded, however, that this
disclosure would have dissuaded an ordinary artisan from applying the
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relevant teachings from the other references to the composition disclosed by
the IJPC.
The IJPC’s formulation is explicitly disclosed as being sublingual (FF
6), which allows a quicker onset of action, as the therapeutic agent is
absorbed through the oral mucosa (see id.; see also FF 11). Thus, an
ordinary artisan would have understood that adding fat to such a formulation
would not have significantly affected its absorption rate, as the drug does not
pass through the digestive system, but is instead absorbed through the oral
mucosa. Moreover, as demonstrated by Chandrakumar and Girsh, the use of
fat-based carriers, including ones that contain cocoa butter and
phospholipids, is in fact desirable in sublingual formulations (FF 20-26).
Thus, even assuming for argument’s sake that Chandrakumar’s
disclosure is equivocal with respect to whether cocoa butter is a suitable
carrier in a sublingual formulation, Girsh makes it clear that fat-containing
vehicles which can include cocoa butter are desirable carriers in sublingual
formulations.
In sum, having fully considered Appellants’ arguments, we are not
persuaded that the Examiner failed to make a prima facie case of
obviousness with respect to representative claims 1 and 3, for the reasons
discussed above. We therefore affirm the Examiner’s rejection of those
claims as obvious over the cited references. The remaining claims fall with
claims 1 and 3. See 37 C.F.R. § 41.37(c)(1)(vii).

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).
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AFFIRMED

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