Ex Parte Domb et al

Board of Patent Appeals and Interferences

May 20, 2010

10083413 (B.P.A.I. May. 20, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte AVRAHAM J. DOMB
and
JOSEPH SIMCHA WOLNERMAN,
Appellants1
____________________

Appeal 2008-003664
Application 10/083,413
Technology Center 1600
____________________

Decided: May 20, 2010
____________________

Before CAROL A. SPIEGEL, DEMETRA J. MILLS, and
STEPHEN WALSH, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from an Examiner's final
rejection of all pending claims, claims 1-4, 6-12, 14-17, 19-26, and 38 (App.

1 The real party in interest is AXIOMEDIC, INC. (Appeal Brief filed 19
October 2006 ("App. Br.") at 2).

Appeal 2008-003664
Application 10/083,413

Br. 2). Oral arguments were held May 11, 2010. We have jurisdiction
under 35 U.S.C. § 134. We AFFIRM-IN-PART.
I. Statement of the Case
The subject matter on appeal is directed to a solid, self-adhesive
composition for topical application that adheres to oral mucosal tissue
comprising (a) a therapeutically effective amount of at least one herbal or
homeopathic active agent and (b) a pharmaceutically acceptable solid
bioadhesive carrier in an amount from about 40 to 99 percent based on the
weight of the whole composition (Spec.2 10, ¶ 5). Claim 1 is the sole
independent claim on appeal and reads (App. Br. 18):
1. A solid, self-bioadhesive composition for
topical application that adheres to oral mucosal
tissue comprising:
(a) a therapeutically effective amount of at
least one herbal active agent wherein the herbal
active agent is selected from the group consisting
of bioactive herbs, herbal extracts, tinctures,
essential oils, and mixtures thereof, and
(b) a pharmaceutically acceptable solid
bioadhesive carrier, comprising a mucoadhesive
synthetic polycarboxylic acid polymer, in an
amount from about 40 to 99 percent based on the
weight of the whole composition in a form suitable
or administration and adhesion to the oral mucosa. f

The bioadhesive carrier of claim 1 may be crosslinked synthetic
polycarboxylic acid polymers and mixtures thereof (claim 22), especially
polyacrylic acid polymers crosslinked with a polyalkenyl polyether,

2 "Spec." refers to the Specification of application 10/083,413 ("the 413
application").
2
Appeal 2008-003664
Application 10/083,413

carboxymethylcellulose, hydroxymethylcellulose, and mixtures thereof
(claim 26) (App. Br. 21).
In one claimed embodiment, the composition of claim 1 is formed into
a disc 2 to 15 mm diameter and 0.4 to 2.3 mm thick which adheres to the
oral mucosa tissue for at least 30 minutes (claim 2) (App. Br. 18). In
another claimed embodiment, the composition of claim 1 has a surface area
ranging from about 0.4 to about 3 cm2 (claim 38) (App. Br. 22).
Other embodiments claim a composition wherein the herbal active
agent is an essential oil (claims 7-8), at least one monoterpene with three
unsaturations (claims 9 and 11), or an essential oil which is a natural or
synthetic mixture consisting of limonene and at least one myrcene, a-pinene,
b-pinene, and sabinene characterized in that at least 60% by weight of the
mixture is limonene (claim 10); or, a composition comprising MgBr2, NaCl,
and/or KCl (claim 12) or carnallite or a salt of carnallite (claim 14).
The Examiner has rejected
(A) claims 1-3, 15-17, 22-24, 26, and 38 as anticipated under 35
U.S.C. § 102(b) by Nagai3 (Ans.4 7);
(B) claims 1-4, 6, 15-17, 22-24, and 38 as anticipated under 35
U.S.C. § 102(b) by Inoue5 (Ans. 3-7); and,
(C) claims 1-4, 6-12, 15-17, 19, 22-24, and 38 as obvious under 35
U.S.C. § 103(a) over Inoue in view of Iyer6 and Friedman7 (Ans. 7-12). The

3 U.S. Patent 4,226,848, Method and Preparation for Administration to the
Mucosa of the Oral or Nasal Cavity, issued 7 October 1980, to Nagai et al.
("Nagai").
4 Examiner's Answer mailed 14 March 2007 ("Ans.").
5 U.S. Patent 4,772,470, Oral Bandage and Oral Preparations, issued 20
September 1988, to Inoue et al. ("Inoue").
3
Appeal 2008-003664
Application 10/083,413

Examiner also relies on Lawless8 and Odian9 as evidence of inherency (Ans.
8, 14, and 18).
Notably, the Examiner has not rejected claims 14, 20, 21, and 25.
In rejection (A), the Examiner found that Nagai described the subject
matter of claims 1-3, 15-17, 22-24, 26, 27, and 38 (Ans. 9). Appellants
acknowledge that Nagai describes compositions comprising a mucosa-
adhesive polymeric matrix comprising about 50% to about 95% by weight
cellulose ether and about 50 to about 5% by weight homo- or co-polymer of
acrylic acid as well as a pharmaceutically effective amount of a medicament
dispersed in the matrix (App. Br. 9). However, Appellants argue that none
of the medicaments described in Nagai are bioactive herbs, herbal extracts,
tinctures, essential oils, or mixtures thereof as required by claim 1 (id.).
Appellants further argue that there is no disclosure in Nagai of crosslinked
matrix polymers as required by claims 22 and 26 (id. at 9-10).
Based on Appellants' patentability arguments, we decide rejection (A)
on the basis of claims 1 and 22. 37 C.F.R. § 41.37(c)(1)(vii). Thus, at issue
in rejection (A) is whether Nagai describes a medicament selected from the
group of bioactive herbs, herbal extracts, tinctures, essential oils, or mixtures
6 U.S. Patent 5,939,050, Antimicrobial Compositions, issued 17 August
1999, to Iyer et al. ("Iyer").
7 U.S. Patent 6,197,305 B1, Anti-Fungal Compositions with Prolonged
Activity, issued 6 March 2001, based on application 09/002,925, filed 5
January 1998, to Friedman et al. ("Friedman").
8 Julia Lawless, THE ILLUSTRATED ENCYCLOPEDIA OF ESSENTIAL OILS: THE
COMPLETE GUIDE TO THE USE OF OILS IN AROMATHERAPY AND HERBALISM,
Element Books 1995, pp. 115, 120, 123, 134, 139-141, 196, and 197
("Lawless").
9 George Odian, PRINCIPLES OF POLYMERIZATION, Third Edition, John Wiley
& Sons, Inc. 1991, pp. 520-521 ("Odian").
4
Appeal 2008-003664
Application 10/083,413

thereof recited in claim 1; and, if so, whether the polymers in the polymeric
matrix of Nagai are crosslinked as required by claim 22.
In rejection (B), the Examiner found that Inoue described the subject
matter of claims 1-4, 6, 15-17, 22-24, and 38 (Ans. 3-6). Appellants
acknowledge that Inoue describes an oral bandage with a soft adhesive film
comprising a mixture of a polycarboxylic acid and/or a polycarboxylic acid
anhydride and a vinyl acetate polymer as well as a topical drug incorporated
into the film (App. Br. 7). However, Appellants argue that Inoue does not
describe a composition comprising a bioadhesive carrier in amount from
about 40 to 99% by weight based on the total weight of Inoue's composition
as required by claim 1 (id. at 7). Appellants further argue that Inoue does
not disclose or suggest compositions having the surface area specified in
claim 38 or formed into discs having the diameters and thicknesses specified
in claims 2 and 3 (id. at 8). Finally, Appellants argue that Inoue does not
describe crosslinked matrix polymers as required by claim 2210 (id.).
Based on Appellants' patentability arguments, we decide rejection (B)
on the basis of claims 1, 2, 22, and 38. 37 C.F.R. § 41.37(c)(1)(vii). Thus,
at issue in rejection (B) is whether Inoue describes a composition comprising
a bioadhesive carrier in amount of about 40 to 99 weight% based on the total
weight of the composition as required by claim 1; and, if so, whether Inoue
describes compositions (a) having a surface area from about 0.4 to about 3
cm2 as required by claim 38, (b) formed into a disc of 2 to 15 mm diameter
and 0.4 to 2.3 mm thickness as required by claim 2, and/or (c) having a
carrier comprising crosslinked polymers as required by claim 22.

10 Although Appellants included claim 26 in this argument, claim 26 has not
been rejected under § 102(b) as anticipated by Inoue.
5
Appeal 2008-003664
Application 10/083,413

In rejection (C), the Examiner found that Inoue described the claimed
invention but for a composition wherein the herbal active agent is an
essential oil (claims 7-8), at least one monoterpene with three unsaturations
(claim 9), or an essential oil which is a natural or synthetic mixture
consisting of limonene and at least one myrcene, a-pinene, b-pinene, and
sabinene characterized in that at least 60% by weight of the mixture is
limonene (claim 10); or, a composition comprising MgBr2, NaCl, and/or
KCl (claim 12) (Ans. 7-9 and 17). The Examiner found that Iyer teaches
that various herbal active agents, including essential plant oils, e.g.,
citronella or lemon oil, and herbal extracts, are useful in oral hygiene
products as antimicrobial agents (id. at 9). The Examiner also found that
Friedman teaches a combination of an herbal extract and an essential oil,
such as a cinnamon, citronella, lemon, or tea-tree oil, that exerts antibacterial,
anti-inflammatory, and antifungal activity on mucosal membranes (id. at 9-
10). The Examiner concluded that it would have been obvious to add at
least an essential oil, such as lemon oil, as taught by Iyer and Friedman to
the active ingredients in the composition of Inoue to provide an oral
antimicrobial composition (id. at 10-11). The Examiner relied on Lawless to
establish that lemon oil comprises 70% limonene, myrcene, pinenes, and
sabinene (id. at 11). The Examiner also concluded that since each of the
references indicated that the various proportions and amounts of ingredients
used are result variables, one of ordinary skill in the art would have routinely
optimized their concentration for the composition's intended use (id. at 11-
12).
Appellants reiterate their argument that Inoue does not describe the
subject matter of claims 1, 2, 3, 22, and 38 set forth in rejection (B) (App. Br.
6
Appeal 2008-003664
Application 10/083,413

12-15). As to rejected claims 7-12 and 19, Appellants argue that none of
Iyer, Friedman, and Lawless teach or suggest a composition comprising a
bioadhesive carrier in amount of about 40 to 99 weight% based on the total
weight of the composition as required by claim 1 and, therefore, claims 7-12
and 19 are not obvious over the combined teachings of Inoue, Iyer,
Friedman, and Lawless (App. Br. 15-16). Appellants further argue that
Inoue fails to teach or suggest a composition comprising MgBr2, NaCl,
and/or KCl as required by claim 12 or a composition containing carnallite or
a salt thereof as required by claim 19 (id. at 15). Appellants also argue that
there is no motivation to combine the teachings of the applied references
(Reply Br.11 13).
Based on Appellants' patentability arguments, we decide rejection (C)
on the basis of claims 1, 2, 7, 12, 19, 22, and 38. 37 C.F.R. §
41.37(c)(1)(vii). Since the issues with regard to claims 1, 2, 22, and 38 are
essentially the same as raised in rejection (B), the new issues before us in
rejection (C) are (i) whether the Examiner has established a sufficient basis
for combining the teachings of the applied references, (ii) whether
Appellants’ proffered showing of unexpected results is sufficient to establish
nonobviousness, and (iii) whether the applied references teach or suggest a
composition comprising the further ingredients of claims 12 (MgBr2, NaCl,
and/or KCl) or 19 (carnallite or a salt thereof).
II. Findings of Fact
The following findings of fact are supported by a preponderance of
the evidence of record.
A. The 413 application

11 Reply to Examiner's Answer filed 14 May 2007 ("Reply. Br.").
7
Appeal 2008-003664
Application 10/083,413

[1] According to the Specification,
The term "bioadhesive" as used herein means an
adhesive which attaches and preferably strongly attaches
to mucosal tissue upon hydration. Indeed, to qualify as a
bioadhesive, a substance must be capable of maintaining
adhesion in moist or wet in-vivo environments. The
final composition of the present invention is "self-
adhesive" in that it attaches to the site of interest without
the need to reinforce its attachment by way of another
adhesive which is applied to a backing. [Spec. ¶
ridging 12-13]. b

[2] Suitable adhesive carriers include nontoxic polymers containing
carboxylic acid, such as copolymers of acrylic or methacrylic acid,
copolymers of maleic acid, polysaccharides, and cellulose and
cellulose derivatives (Spec. 12, ¶ 2; 13, ¶¶ 2-3).
[3] A particularly preferred carrier contains "mixtures of slightly
crosslinked polyacrylic acid, i.e. Carbopol 940, 934, 974, and the like,
carboxymethyl cellulose and hydroxypropylmethyl cellulose
(HPMC)" (Spec. 12, ¶ 2).
[4] According to the Specification, Carbopol 934, 934P, 974, 940, and
941 are "polyacrylic acid polymers lightly crosslinked with a
polyalkenyl polyether" which are commercially available from B.F.
Goodrich (Spec. 13, ¶ 1).
B. Nagai
[5] Nagai describes oral or nasal mucosa-adhesive preparations
comprising a polymeric matrix containing (a) about 50 to about 95%
by weight of a cellulose ether and about 50 to about 5% by weight of
a homo- or copolymer of acrylic acid or a pharmaceutically acceptable
8
Appeal 2008-003664
Application 10/083,413

salt thereof; and (b) dispersed therein, a pharmaceutically effective
amount of a medicament (Nagai, col. 2, l. 67-col. 3, l. 10).
[6] Exemplary medicaments include anti-inflammatory steroids, such as
hydrocortisone and dexamethasone, cardiac tonics such as digitalis
and digoxin, and topical anaesthetics, such as benzocaine, which can
be used singly or in combination (Nagai, col. 5, l. 58-col. 6, l. 19).
[7] Exemplary matrices comprise mixtures of hydroxypropyl cellulose
and Carbopol 934 (Nagai, col. 13, ll. 47-55; col. 14, ll. 53-55).
C. Inoue
[8] Inoue describes an oral bandage for administering an active agent to
the oral mucosa comprising (i) a "compatible" mixture of a
polycarboxylic acid and/or a polycarboxylic acid anhydride
(collectively "polycarboxylic acids") and a vinyl acetate polymer
(hereinafter "polyvinyl acetate"), and (ii) a topical drug (Inoue, col. 2,
ll. 24-38; col. 3, ll. 8-15).
[9] The polycarboxylic acids and polyvinyl acetate are "uniformly
dissolved in each other without forming small individual regions due
to phase separation" (Inoue, col. 2, ll. 32-38) and can be formed into a
thin and soft film which exerts strong adhesion for an extended period
of time without degrading, generally 3 to 4 hours or longer (id. at col.
2, l. 60-col. 3, l. 2; col. 11, ll. 2-10).
[10] The ability of Inoue's mixture of polycarboxylic acids and polyvinyl
acetate to uniformly swell without degradation even when immersed
in water for a considerably long period of time is present whether or
not a neutralizing basic substance, such as zinc oxide or sodium
9
Appeal 2008-003664
Application 10/083,413

acetate, is also present in the mixture (Inoue, col. 4, ll. 3-11; col. 5, ll.
13-18).
[11] The "compatibility" of Inoue's mixture is defined by a dissolution
ratio of polycarboxylic acids of 40 wt. % or less or, in the presence of
a neutralizing salt, a ratio of 50 wt. % or less (Inoue, col. 4, ll. 21-31).
[12] Inoue believes that
the polycarboxylic acids contribute to
adhesiveness to the wet mucosa and the polyvinyl
acetate contributes to water resistance in a
compatible mixture thereof, thus functioning in
harmony to show adhesion of long duration (Inoue,
col. 5, ll. 3-8).

[13] Typically, the topical drug is added directly or in the form of a
solution to a solution of polycarboxylic acids and polyvinyl acetate,
and the resulting solution is cast onto a thin film, e.g., polyethylene-
laminated paper, subjected to releasability-imparting treatment, dried,
and peeled off to produce an oral bandage comprising a drug-
incorporated adhesive film (Inoue, col. 5, l. 66-col. 6, l 5; col. 7, l. 64-
col. 8, l. 11; Examples 7-9 and 20 to 37).
[14] The thickness of the resulting film is preferably from 5 to 100 µm
because it is difficult to obtain sufficient adhesion with a film less
than 5 µm, while a film thicker than 100 µm feels foreign and has
impaired softness (Inoue, col. 8, ll. 11-17).
[15] While Inoue's oral bandage "may solely comprise the adhesive film,"
it may further comprise a soft film support in combination, i.e., a
"composite film" (Inoue, col. 8, ll. 30-33).
[16] The film support is typically a substantially water impermeable plastic
film having a thickness from 10 to 100 µm (Inoue, col. 8, ll. 45-55).
10
Appeal 2008-003664
Application 10/083,413

[17] Exemplary topical drugs include steroids, e.g., dexamethasone, anti-
inflammatories, e.g., Lithospermi Radix extract, and analgesics, e.g.,
lidocaine (Inoue, col. 9, ll. 6-53).
[18] The amount of incorporated topical drug usually ranges from 0.0001
to 35 wt. %, based on the preparation (Inoue, col. 9, ll. 54-60).
D. Iyer
[19] Iyer teaches antibacterial compositions for use in oral hygiene
products, e.g., dentrifices and mouth rinses, comprising two agents, A
and B, one of which when in combination the other is able to inhibit
or prevent bacterial growth at a concentration lower than the
concentration needed in the absence of the other (Iyer, col. 3, ll. 5-10
and ll. 47-51).
[20] The composition can be used by contacting a surface where inhibition
of bacterial growth is desired with the composition (Iyer, col. 3, ll. 53-
55; col. 7, ll. 16-18).
[21] Suitable agents A and B include cedarwood oil, citronella oil,
Glycyrrhiza glabra extract (licorice root extract), and lemon oil (Iyer,
col. 3, ll. 11-27; col. 4, ll. 34-36).
[22] Table 3 illustrates how combining various agent Bs, including
citronella oil (CTR1), lemon oil (LMO1), and Glycyrrhiza glabra
extract, a specific agent A, cedarwood oil (RC1), decreases the
minimum inhibitory concentration ("MIC") of cedarwood oil alone
(Iyer, col. 10, ll. 13-34).
[23] Suitable amounts of each agent range from about 0.001 wt. % to about
5.0 wt. % based on the total weight of composition containing the
agents (Iyer, col. 7. ll. 12-15).
11
Appeal 2008-003664
Application 10/083,413

E. Friedman
[24] Friedman discloses a composition comprising specific combinations
of essential oils and herbal extracts for topical application to mucosal
membranes, e.g., the oral cavity, for treating microbial infections
caused by bacteria or fungi (Friedman, col. 1, ll. 6-21; col. 2, ll. 20-28;
col. 3, ll. 8-17; col. 4, ll. 30-36).
[25] Preferred essential oils include cinnamon oil, citronella oil, lemon oil,
and tea-tree oil, preferably from about 0.2 to about 2.0 wt. %
(Friedman, col. 2, ll. 37-49).
[26] Preferred herbal extracts include Glycerrhiza extracts, preferably from
about 1 to about 10 wt. % (Friedman, col. 2, ll. 50-59).
[27] Compositions for local oral administration may be in the form of
toothpastes, creams, ointments, gels, solutions, or chewable tablets
(Friedman col. 9, l. 66-col. 10, l. 4).
F. Lawless
[28] According to Lawless, the principal components of essential lemon oil
are limonene (approximately 70%), terpinene, pinenes, sabinene,
myrcene, citral, linalool, geraniol, octanol, nonanol, citronellal, and
bergamontene (Lawless 120).
G. Odian
[29] According to Odian,
Neutralization of ethylene copolymers containing
up to 5-10% acrylic or methacrylic copolymer with a
metal salt such as the acetate or oxide of zinc, sodium,
magnesium, barium, or aluminum yields products
referred to as ionomers … Ionomers act like reversibly
crosslinked thermoplastics as a result of microphase
separation between ionic metal carboxylate and
12
Appeal 2008-003664
Application 10/083,413

nonpolar hydrocarbon segments. The behavior is
similar to the physical crosslinking in thermoplastic
elastomers … (Odian 520).

III. Discussion
A. Legal principles
Anticipation requires that a prior art reference describe every
limitation in a claim either explicitly or inherently. In re Schreiber, 128
F.3d 1473, 1477 (Fed. Cir. 1997). "Inherency, however, may not be
established by probabilities or possibilities. The mere fact that a certain
thing may result from a given set of circumstances is not sufficient." In re
Oelrich, 666 F.2d 578, 581 (CCPA 1981). Nonetheless, as stated in In re
Best, 562 F.2d 1252, 1255 (CCPA 1977),
Where … the claimed and prior art products are
identical or substantially identical, … the PTO can
require an applicant to prove that the prior art
products do not necessarily or inherently possess
the characteristics of his claimed product….
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.

An invention is obvious if "the differences between the subject matter
sought to be patented and the prior art are such that the subject matter as a
whole would have been obvious . . . to a person having ordinary skill in the
art to which said subject matter pertains." 35 U.S.C. § 103. The factual
inquiries underlying obviousness include (1) the scope and content of the
prior art, (2) the differences between the prior art and the claims at issue, (3)
the level of ordinary skill in the art at the time the invention was made, and
13
Appeal 2008-003664
Application 10/083,413

(4) any objective evidence of non-obviousness. Graham v. John Deere Co.,
383 U.S. 1, 17-18 (1966).
“The consistent criterion for determination of obviousness is whether
the prior art would have suggested to one of ordinary skill in the art that this
process should be carried out and would have a reasonable likelihood of
success, viewed in the light of the prior art.” In re Dow Chem. Co., 837 F.2d
469, 473 (Fed. Cir. 1988). In determining whether obviousness is
established by combining the teachings of the prior art, “the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981).
Furthermore, in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court rejected a rigid application of a teaching-suggestion-
motivation test in the obviousness determination. The Court emphasized
that “the [obviousness] analysis need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418; see also id. at 421 (“A person of ordinary
skill is . . . a person of ordinary creativity, not an automaton.”). Thus, an
“[e]xpress suggestion to substitute one equivalent for another need not be
present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301
(CCPA 1982).
“Obviousness does not require absolute predictability of success. . . .
[A]ll that is required is a reasonable expectation of success.” In re O'Farrell,
853 F.2d 894, 903-04 (Fed. Cir. 1988). “[W]hen unexpected results are used
as evidence of nonobviousness, the results must be shown to be unexpected
14
Appeal 2008-003664
Application 10/083,413

compared with the closest prior art.” In re Baxter-Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991).
B. Analysis
1. Rejection (A)
a. claim 1
The Examiner rejected claims 1-3, 15-17, 22-24, 26, and 38 as
anticipated under § 102(b) by Nagai. Claim 1 is the sole independent claim
on appeal. Claim 1 requires, in relevant part, a composition comprising "a
therapeutically effective amount of at least one herbal active agent wherein
the herbal active agent is selected from the group consisting of bioactive
herbs, herbal extracts, tinctures, essential oils, and mixtures thereof." While
Nagai describes oral mucosa-adhesive preparations containing a
therapeutically effective amount of a medicament (FF 5), Nagai does not
explicitly describe any medicament as a bioactive herb, herbal extract,
tincture, and/or essential oil. Although the Examiner correctly found that
Nagai's described medicaments include drugs such as digitalis and digoxin
(FF 6), as pointed out by Appellants (Reply Br. 6-7; Surreply 7), these drugs
may be prepared synthetically. Absent a sufficient factual basis establishing
that any particular drug described by Nagai, such as digitalis, is inherently a
herbal extract as claimed, we must reverse the rejection of claim 1 under §
102(b) over Nagai. Inherency cannot be established by probabilities or
possibilities. For example, the mere fact that digitalis was originally isolated
from plants of the genus Digitalis is insufficient to establish that the digitalis
described in Nagai is a herbal extract as opposed to a synthetic drug.
Therefore, we reverse the rejection of claim 1, and claims 2-3, 15-17,
22-24, 26, and 38 dependent thereon, as anticipated under § 102(b) by Nagai.
15
Appeal 2008-003664
Application 10/083,413

2. Rejection (B)
a. claim 1
The Examiner rejected claims 1-4, 6, 15-17, 22-24, and 38 as
anticipated under § 102(b) by Inoue. Claim 1, the sole independent claim on
appeal, recites, in relevant part, a composition comprising "a
pharmaceutically acceptable solid bioadhesive carrier, comprising a
mucoadhesive synthetic polycarboxylic acid polymer, in an amount from
about 40 to 99 percent based on the weight of the whole composition in a
form suitable for administration and adhesion to the oral mucosa."
Appellants argue that Inoue fails to meet this claim limitation.
Inoue describes a film composition for administering an active
ingredient, e.g., Lithospermi Radix extract, incorporated into a compatible
mixture of polycarboxylic acids and polyvinyl acetate, to the oral mucosa
(FF 8, 13, and 17). Appellants argue that polyvinyl acetate is
nondegradable and, therefore, Inoue's films must be removed from the
mouth after the active ingredient has been released (Surreply 3-4). We
understand Appellants to argue that Inoue does not describe a bioadhesive as
claimed. However, this argument is not commensurate in scope with claim
1 and, therefore, is not persuasive.
According to the 413 Specification, a bioadhesive is an adhesive
which attaches to mucosal tissue upon hydration, which maintains adhesion
in moist or wet in vivo environments, and which attaches to the oral mucosa
without the need for reinforcement by means of another adhesive which is
applied to a backing (FF 1). Inoue's bioadhesive is a carefully defined
"compatible" mixture of polycarboxylic acids and polyvinyl acetate formed
into a thin and soft film which exerts strong adhesion to the wet oral mucosa
16
Appeal 2008-003664
Application 10/083,413

for an extended period of time (FF 8-9). Inoue's bioadhesive film attaches to
the oral mucosa without the need for reinforcement (FF 15). Thus, Inoue's
bioadhesive film is a bioadhesive as defined in the 413 Specification.
Appellants also argue that Inoue's bioadhesive carrier film is not
present in the required amount of about 40 to 99% by weight of the total
composition. However, as found by the Examiner (Ans. 12-13; Supp. Ans.12
13), Inoue discloses that the amount of drug incorporated usually ranges
from 0.0001 to 35% by weight based on the weight of the composition (FF
18). Thus, the Examiner reasoned that Inoue's composition contained an
amount of bioadhesive carrier within the claimed range. We agree with the
Examiner that there is a sufficient factual basis for reasonably believing that
the composition of Inoue is the same or substantially the same as the claimed
composition and Appellants have not shown otherwise. In re Best, 562 F.2d
at 1255.
At best, Appellants argue that Inoue's composition may contain other
additives, e.g., neutralizing substances, and residual solvent from casting the
film, as well as a support film of unknown weight (App. Br. 7; Reply Br. 3).
However, Inoue teaches that such additives and support films are optional
(FF 10 and 15) and Appellants have not shown that residual solvent from
casting would have reduced the amount of bioadhesive carrier in Inoue's
composition to less than 40% by weight.
Therefore, we agree with the Examiner that the subject matter of
claim 1 is described by Inoue. Since claims 4, 6, 15-17, 23, and 24 have not
been separately argued by Appellants, we sustain the rejection of claims 1, 4,
6, 15-17, 23, and 24 under § 102(b) as anticipated by Inoue.

12 Examiner's Answer mailed 29 August 2007 ("Supp. Ans.").
17
Appeal 2008-003664
Application 10/083,413

b. claims 2 and 38
Appellants further argue that Inoue fails to describe a composition in
the form of a disc having the diameters and thicknesses recited in claims 2
and 3. Specifically, claims 2 and 3 recite thicknesses of 0.4 to 2.3 mm and 1
to 2 mm, respectively. Inoue describes compositions with bioadhesive
carrier films having thicknesses of from 5 to 100 µm, i.e., from 0.005 to 0.1
mm (FF 14). Assuming arguendo that Inoue's composition further
comprised a support film, Inoue describes support films as having a
thickness from 10 to 100 µm, i.e., from 0.010 to 0.100 mm (FF 16). Thus,
while Inoue describes compositions with thicknesses of at least 5 µm as
argued by the Examiner, Inoue does not explicitly describe compositions
with thicknesses of at least 0.4 mm. Moreover, the Examiner has not
established a sufficient factual basis for finding that Inoue inherently
describes compositions with a thickness of at least 0.4 mm. Rather, it
reasonably appears that Inoue probably suggests compositions with
thicknesses about 0.2 mm (see FF 14 and 16). Similarly, the Examiner
directs our attention to column 8, lines 45-61, of Inoue for a description of a
composition having a diameter from 5 mm to 20 mm (Ans. 14; Supp. Ans.
14). However, as noted by Appellants (see e.g., Surreply 5), we find no such
disclosure at that cite.
Therefore, we agree with Appellants that the subject matter of claims
2, 3, and 38 is not described by Inoue.
c. claim 22
Finally, Appellants argue that Inoue fails to describe a bioadhesive
carrier comprising crosslinked polycarboxylic acids (claim 22). As pointed
out by the Examiner (Ans. 14; Supp. Ans. 14), Inoue describes neutralizing
18
Appeal 2008-003664
Application 10/083,413

polycarboxylic acids with metal salts, e.g., zinc oxide (FF 10). The
Examiner maintains that the neutralization reaction will inherently cause the
polycarboxylic acids to crosslink as evidenced by Odian (Ans. 14-15; Supp.
Ans. 14-15). However, as noted by Appellants (Reply Br. 5-6; Surreply 5-6),
Odian teaches that neutralizing poly(meth)acrylic acids (i.e., polycarboxylic
acids) with metal salts, e.g., zinc oxide, yields ionomers which behave like
crosslinked thermoplastics as a result of microphase separation, not that the
neutralization causes physical crosslinking per se as asserted by the
Examiner (FF 29).
Therefore, we agree with Appellants that the subject matter of claim
22 is not described by Inoue.
To summarize, we sustain the rejection of claims 1, 4, 6, 15-17, 23,
and 24 under § 102(b) as anticipated by Inoue, but reverse the rejection of
claims 2, 3, 22, and 38.
3. Rejection (C)
The Examiner rejected claims 1-4, 6-12, 15-17, 19, 22-24, and 38 as
obvious under § 103(a) over Inoue in view of Iyer and Friedman, as
evidenced by Lawless.
a. claim 1
We have found claims 1, 4, 6, 15-17, 23, and 24 anticipated by Inoue
under § 102(b). Since anticipation is the ultimate of obviousness, the subject
matter of these claims is necessarily obvious and we need not consider them
further. Thus, we sustain the rejection of claims 1, 4, 6, 15-17, 23 and 24
under § 103(a) as obvious over Inoue in view of Iyer and Friedman. In re
Fracalossi, 681 F.2d 792, 794 (CCPA 1982).
b. claims 2, 22, and 38
19
Appeal 2008-003664
Application 10/083,413

The Examiner has not provided an alternative obviousness analysis
for the subject matter of claims 2, 3, 22, and 38 over the combined teachings
of Inoue, Iyer, and Friedman. Therefore, we summarily reverse the rejection
of claims 2, 3, 22, and 38 under § 103(a) as obvious over the combined
teachings of Inoue, Iyer, and Friedman.
c. claims 7, 12, and 19
Appellants argue that claims 7-12 and 19 are unobvious because none
of the applied references teach or suggest a composition comprising a
bioadhesive carrier in amount of about 40 to 99 weight% based on the total
weight of the composition as required by claim 1. This argument is not
persuasive because we find claim 1 anticipated by Inoue for the reasons
given above.
i. claims 12 and 19
Appellants further argue that Inoue fails to teach or suggest a
composition comprising MgBr2, NaCl, and/or KCl as required by claim 12
or a composition containing carnallite or a salt thereof as required by claim
19 (App. Br. 15). We do not find, and the Examiner has not indicated,
where Inoue, Iyer, and/or Friedman or any other evidence of record teach or
suggest the limitations of claims 12 and 19. Therefore, we reverse the
rejection of claims 12 and 19 as obvious under § 103(a) over the combined
teachings of Inoue, Iyer, and Friedman.
ii. claim 7
Appellants also argue that there is no motivation to combine the
teachings of the applied references (App. Br. 14; Reply Br. 13). In particular,
Appellants argue that one of ordinary skill in the art would not have been
motivated to combine the non-bioadhesive formulations of Iyer, Friedman,
20
Appeal 2008-003664
Application 10/083,413

and Lawless with the bioadhesive formation of Inoue (App. Br. 16). This
argument is not persuasive.
Here, Iyer teaches using a combination of herbal active agents,
including cedarwood oil, citronella oil, lemon oil, and/or Glycyrrhiza glabra
(licorice root) extract for topical application to the oral mucosa to inhibit or
prevent bacterial growth (FF 19-23). Similarly, Friedman teaches using
specific combinations of essential oils, such as cinnamon oil, citronella oil,
lemon oil, and tea-tree oil, and herbal extracts, such as Glycerrhiza extracts,
for topical application to the oral mucosa to treat microbial infections caused
by bacteria or fungi (FF 24-26). As evidenced by Lawless, lemon oil
contains approximately 70% limonene, with the remainder comprising
terpinene, pinenes, myrcene, and sabinene (FF 28). Iyer and Friedman both
teach topical application of their formulations directly to oral surfaces (FF
19-20 and 24), albeit not in a formulation comprising a bioadhesive carrier
film as taught by Inoue. However, Inoue teaches and/or suggests
administering active agents, such as plant extracts, to oral mucosal surfaces
(FF 9, 17). The test for determining obviousness is what the combined
teachings of the references would have suggested to one of ordinary skill in
the art. In re Keller, 642 F.2d at 425. Here, we agree with the Examiner
that Iyer and Friedman suggests incorporating a combination of herbal active
agents, including at least an essential oil, such as lemon oil, into Inoue's
"oral bandage," a composition known to be useful for topical administration
of drugs, including herbal active agents, to the oral mucosal cavity, to inhibit
or prevent undesired microbial growth in the mouth. Therefore, this
argument is not persuasive.
21
Appeal 2008-003664
Application 10/083,413

Consequently, we sustain the rejection of claims 7-11 under § 103
over the combined teachings of Inoue, Iyer, and Friedman, as evidenced by
Lawless.
d. claims 1 and 7
Appellants additionally argue that the claimed invention provides
unexpected results (Surreply 16-17). Specifically, Appellants contend that
Examples 4 and 6 of the 413 Specification illustrate unexpected efficacy of
the claimed compositions vis-à-vis the films described in Inoue (id.). The
tablets of Example 4 were prepared by compression molding of herbal active
compositions in powder form and mixtures of Carbopol 940, HPMC, and
other ingredients, such as magnesium stearate (see e.g., Spec. 29-31).
None of the claimed compositions are limited to compression molded tablets
formed from mixtures of Carbopol 940 and HPMC or require magnesium
stearate. Similarly, Example 6 of the 413 Specification describes treating 17
patients with recurrent aphthous stomatitis with compositions loaded with
carnallite, citron oil, and benzocaine. None of the claimed compositions are
limited to the compositions described in Example 6 of the 413 Specification.
Furthermore, no direct comparison was made with the compositions of Inoue,
e.g., using the same active ingredients on the same 17 patients. Thus,
Appellants' proffered showing of unexpected results is neither
commensurate in scope with the claimed invention nor a comparison with
the closest prior art. Therefore, this showing is insufficient evidence of
nonobviousness.
To summarize, we sustain the rejection of claims 1, 4, 6-11, 15-17, 23,
and 24 under § 103 over Inoue, Iyer, and Friedman, as evidenced by Lawless,
but reverse the rejection of claims 2, 3, 12, 19, 22, and 38.
22
Appeal 2008-003664
Application 10/083,413

C. Conclusion
The rejection of claims 1-3, 15-17, 22-24, 26, and 38 under § 102 over
Nagai is reversed because Nagai does not describe a composition comprising
a bioactive herb, a herbal extract, a tincture, and/or an essential oil.
The rejection of claims 1, 4, 6, 15-17, 23, and 24 under § 102 over
Inoue is sustained because the evidence of record supports the finding that
Inoue describes a composition comprising a bioadhesive carrier in an
amount of about 40 to 99 wt. % based on the total weight of the composition.
However, the rejection of claims 2, 3, 22, and 38 under § 102 over Inoue is
reversed because the evidence of record fails to support a finding that Inoue
describes compositions having the claimed diameters, thicknesses, surface
area, or crosslinked polymers.
The rejection of claims 1, 4, 6, 15-17, 23, and 24 under § 103 over
Inoue, Iyer, and Friedman as evidenced by Lawless is sustained because the
evidence of record supports the finding that Inoue describes a composition
comprising a bioadhesive carrier in an amount of about 40 to 99 wt. % based
on the total weight of the composition. However, the rejection of claims 2, 3,
12, 19, 22, and 38 under § 103 over Inoue, Iyer, and Freidman as evidenced
by Lawless is reversed because the evidence of record fails to support a
finding that Inoue describes compositions having the claimed diameters,
thicknesses, surface area, crosslinked polymers, or additional ingredients,
i.e., MgBr2, NaCl, KCl, carnallite or a salt thereof.
Claims 14, 20, 21, and 25 have not been rejected by the Examiner.
IV. Order
Upon consideration of the record, and for the reasons given, it is
23
Appeal 2008-003664
Application 10/083,413

ORDERED that the decision of the Examiner to reject claims 1-3, 15-
17, 22-24, 26, and 38 as anticipated under § 102 by Nagai is REVERSED;
FURTHER ORDERED that the decision of the Examiner to reject
claims 1, 4, 6, 15-17, 23, and 24 as anticipated under § 102 by Inoue is
AFFIRMED;
FURTHER ORDERED that the decision of the Examiner to reject
claims 2, 3, 22, and 38 as anticipated under § 102 by Inoue is REVERSED;
FURTHER ORDERED that the decision of the Examiner to reject
claims 1, 4, 6-11, 15-17, 23, and 24 as obvious under § 103 over the
combined teachings of Inoue, Iyer, and Friedman, as evidenced by Lawless,
is AFFIRMED,
FURTHER ORDERED that the decision of the Examiner to reject
claims 2, 3, 12, 19, 22, and 38 as obvious under § 103 over the combined
teachings of Inoue, Iyer, and Friedman, as evidenced by Lawless, is
REVERSED, and
FURTHER ORDERED that no that no time period for taking any
subsequent action in connection with this appeal may be extended under 37
C.F.R. § 1.136(a).
AFFIRMED-IN-PART

cdc
PATREA L. PABST
PABST PATENT GROUP LLP
400 COLONY SQUARE, SUITE 1200
1201 PEACHTREE STREET
ATLANTA, GA 30361
24