Ex Parte Seidel et al

Board of Patent Appeals and Interferences

Apr 27, 2010

10196520 (B.P.A.I. Apr. 27, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MATTHIAS SEIDEL and CHRISTOPHER BUCKLEY
__________

Appeal 2010-002888
Application 10/196,520
Technology Center 1600
__________

Decided: April 27, 2010
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge, GREEN.

Opinion Dissenting in part filed by Administrative Patent Judge, ADAMS.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1, 2, 4-6, and 9-27. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claim 17 is representative of the claims on appeal, and reads as
follows:
17. A liquid nasal pharmaceutical composition which comprises
(a) one or more active substances selected from the group consisting
of vasoconstrictors, antiallergic agents and corticosteroids,
(b) sorbitol;
(c) a water-soluble C1-C4-alkyl-cellulose derivative selected from the
group consisting of methyl cellulose, hydroxy-substituted C1-C4-alkyl-
cellulose and carboxy-substituted C1-C4-alkyl-cellulose, and
(d) a vehicle which is present in an amount of at least 90% (m/V) of
the total composition and selected from water and mixtures of water with
propylene glycol and/or glycerol having water in an amount of at least 95%
(m/V), and
wherein said composition is a solution composition that is adapted for
nasal administration.

The Examiner relies on the following evidence:
Morita EP 0582259 A2 Feb. 1994

Fradis, Treatment of perennial allergic rhinitis by sodium cromoglycate plus
0.025 per cent xylometazoline (a double-blind study), 101 J. Laryngol Otol.
666-72 (1987) (Abstract only).

Sengelmann, What About Nose Drops In Kids, 62 Ohio State Med. J., 141-
42 (1996).

We affirm.

ISSUE
Has the Examiner established that Morita anticipates the claimed
composition within the meaning of § 102?

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FINDINGS OF FACT
FF1 The Examiner rejects claims 1, 2, 5, 6, and 9-20 under 35 U.S.C.
§ 102(b) as being anticipated by Morita. (Ans. 3.)
FF2 The Examiner finds that Morita “discloses a composition of a water
soluble drugs or scarcely soluble drugs, for local use containing antiallergics
and vasoconstrictors.” (Id. at 4.)
FF3 As to element (b) of the composition of claim 17, the Examiner finds
that Morita teaches isotonizers, such as sorbitol. (Id. (citing Morita 4, l. 6.).)
FF4 As to element (c) of the composition of claim 17, the Examiner finds
that Morita teaches the use of carboxymethylcellulose and
hydroxypropylcellulose. (Id. at 4-5 (citing Morita, p. 4, ll. 5-6.).)
FF5 Morita relates to “an aqueous preparation for local treatment
characterized in that it comprises suspension particulates of water soluble
polymers which will dissolve or gel at a pH within a pH range of secreted
fluid at a local si[d]e of the body and a drug which can be locally applied.”
(Morita 2, ll. 3-5.)
FF6 Morita teaches further:
In these preparations, additives conventionally used for
aqueous preparations can be added. The examples of such
additives include preservatives (such as p-hydroxybenzoates,
benzalkonium chloride, chlorobutanol), stabilizers (such as
sodium edetate, sodium citrate), suspending agents (such as
carboxymethylcellulose, hydroxypropylcellulose), isotonizers
(sodium chloride, sorbitol, glycerol), surface active agents
(such as polysorbate 80) and buffering agents (such as sodium
dihydrogen phosphate, boric acid, citric acid), and pH adjusting
agents (such as hydrochloric acid, acetic acid, sodium
hydroxide).
(Id. at 4, ll. 3-8 (emphasis added).)
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PRINCIPLES OF LAW
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001). “[R]ejections under 35 U.S.C. § 102 are proper only when the
claimed subject matter is identically disclosed or described in ‘the prior
art.’” In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Thus, an anticipatory
reference under 35 U.S.C. § 102 “must clearly and unequivocally disclose
the claimed [subject matter] or direct those skilled in the art to the [claimed
subject matter] without any need for picking, choosing, and combining
various disclosures not directly related to each other by the teachings of the
cited reference.” In re Arkley, 455 F.2d 586, 587 (CCPA 1972). We
recognize, however, that a generic disclosure may anticipate a claim to a
species within the generic disclosure. E.g., In re Schaumann, 572 F.2d 312
(CCPA 1978). The test for anticipation “is not an ‘ipsissimis verbis’ test.”
In re Bond, 910 F.2d 831, 832 (Fed. Cir. 1990).

ANALYSIS
Appellants argue that as to the anticipation rejection over Morita:
The sole portion of Morita arguably relevant to applicants’
invention is the broadbrush teaching of additional “additives” to
compositions of such suspension particulates, spanning seven
different categories of additive and encompassing 17 different
species. Included within that teaching is the mention of
carboxymethylcellulose and hydroypropylcellulose as possible
“suspending agents” and of sorbitol as a possible “isotonizer”.
No example utilizes carboxymethylcellulose or
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hydropropylcellulose. No example utilizes sorbitol. No
teaching or example utilizes any combination of these, let alone
in any particular amounts. The one example directed to nasal
drops, does not include either a suspending agent or an
isotonizer. The combination of an alkyl cellulose derivative
with sorbitol to serve as an anticipation of applicants’ claims
can only be arrived at by impermissible “picking and choosing”
from Morita.

(App. Br. 3-4.)
We agree with Appellants’ argument as set forth above. While
“[s]uch picking and choosing may be entirely proper in the making of a 103,
obviousness rejection . . . it has no place in the making of a 102, anticipation
rejection.” Arkley, 455 F.2d at 587. We agree that the reference need not
literally disclose one single embodiment meeting all the claimed element.
But in this case, Morita merely discloses sorbitol as one of a number of
isotonizers that may be used, and also discloses the use of
carboxymethylcellulose and hydroxypropylcellulose as possible suspending
agents. The disclosure of Morita, however, does not direct one to a
composition comprising all of the elements of claim 1. Thus, we conclude
that while Morita may render the claimed composition obvious, there is
nothing specifically directing the ordinary artisan to the specific claimed
composition so as to render it anticipated by Morita.

CONCLUSION OF LAW
We conclude that the Examiner has not established that Morita
anticipates the claimed composition within the meaning of § 102.
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We are thus compelled to reverse the rejection of claims 1, 2, 5, 6, and
9-20 under 35 U.S.C. § 102(b) as being anticipated by Morita.

ISSUE
Does the evidence of record support the Examiner’s conclusion that
Morita as combined with either Sengelmann or Fradis render the
composition of claim 17 obvious?

FINDINGS OF FACT
FF7 The Examiner rejects claims 1, 2, 5, 6, and 9-27 under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Morita and
Sengelmann. (Ans. 5.) As Appellants do not argue the claims separately,
we focus our analysis on claim 17, and claims 1, 2, 5, 6, 9-16, and 18-27
stand or fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
FF8 The Examiner relies on the teachings of Morita as set forth above.
(Ans. 5.)
FF9 Specifically, the Examiner notes that “[a]ll the ingredients as claimed
are taught by [Morita].” (Id.)
FF10 The Examiner notes that Morita teaches the use of vasoconstrictors as
the active agent, “but does not specifically recite ‘xylometazoline’ (which is
the elected species in this application).” (Id. at 6.)
FF11 The Examiner cites Sengelmann “to show . . . why one skilled in the
art would select to exemplify ‘xylometazoline’ as in [the] present invention.”
(Id.)
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FF12 The Examiner rejects claims 1, 2, 4-6, and 9-27 under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Morita and Fradis.
(Id. at 7.) As Appellants do not argue the claims separately, we focus our
analysis on claim 1, and claims 2, 4-6, and 9-27 stand or fall with that claim.
FF13 The Examiner relies on the teachings of Morita as set forth above.
(Id.)
FF14 The Examiner cites Fradis for teaching “treatment of perennial
allergic rhinitis by the combination of sodium cromoglycate and
xylometazoline.” (Id at 8.)

PRINCIPLES OF LAW
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently 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.” KSR
Int’l v. Teleflex Inc., 550 U.S. 398. 418 (2007).
Under the correct obviousness analysis, “any need or problem known
in the field of endeavor at the time of invention and addressed by the patent
can provide a reason for combining the elements in the manner claimed.”
Id. at 420. Thus, for a prima facie case of obviousness to be established, the
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references need not recognize the problem solved by Appellants. In re
Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996); In re Beattie, 974 F.2d 1309,
1312 (Fed. Cir. 1992); Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. &
Int. 1985) (“The fact that appellant has recognized another advantage which
would flow naturally from following the suggestion of the prior art cannot
be the basis for patentability when the differences would otherwise be
obvious.”)
The burden of demonstrating unexpected results rests on the party
asserting them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972).
“[U]nexpected results must be established by factual evidence. Mere
argument or conclusory statements in the specification does not suffice.” In
re DeBlauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).

ANALYSIS
Appellants argue as to the rejection over Morita as combined with
Sengelmann, Appellants argue that Morita is drawn to a different
composition in which particles of a cellulose ester are suspended, whereas
“the present composition does not contain suspended or un-dissolved
cellulose particles.” (App. Br. 4.) Appellants assert that “[t]here is nothing
in Morita that teaches or suggests the use of applicants’ claimed cellulose
polymers in combination with sorbitol to improve the moisturizing
properties of a nasal composition.” (Id. at 5.) Appellants reiterate the above
rejection as to the rejection over the combination of Morita and Fradis. (Id.
at 6.)
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Appellants arguments have been carefully considered, but are not
deemed to be convincing. While Morita may not anticipate a composition
comprising an active agent, such as a vasoconstrictor, sorbitol, a water-
soluble C1-C4-alkyl-cellulose derivative selected from the group consisting
of methyl cellulose, hydroxy-substituted C1-C4-alkyl-cellulose and
carboxysubstituted C1-C4-alkyl-cellulose, as well as a vehicle, as discussed
with respect to the anticipation rejection, it does render such a composition
obvious. Moreover, the use of the transition term “comprising” does not
exclude the addition of particles of a cellulose ester. In addition, while
Morita does not suggest the addition of sorbitol for improving the
moisturizing properties of a nasal composition, it does suggest the addition
of a sorbitol as a isotonizer, and the reason for adding the sorbitol taught by
the prior art need not be the same as that of Appellants in order to render a
claimed composition obvious.
Appellants argue further that that the Specification demonstrates an
increase in passive ionic flux. (App. Br. 6 (citing Specification, p. 5).) The
Specification, however, does not present any data at page 5, and unexpected
results need be demonstrated by factual evidence.

CONCLUSION OF LAW
We conclude that the evidence of record does support the Examiner’s
conclusion that Morita as combined with either Sengelmann or Fradis
renders the composition of claim 17 obvious.
We thus affirm the rejection of claims 1, 2, 5, 6, and 9-27 under 35
U.S.C. § 103(a) as being rendered obvious by the combination of Morita and
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Sengelmann; as well as the rejection of claims 1, 2, 4-6, and 9-27 under 35
U.S.C. § 103(a) as being rendered obvious by the combination of Morita and
Fradis.

AFFIRMED

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Adams, Administrative Patent Judge, dissenting in part

Anticipation:

ISSUE
Is the genus of isotonizers and suspending agents disclosed by Morita
as additives conventionally used for aqueous preparations so large as to
defeat a prima facie case of anticipation?

FINDINGS OF FACT
FF 15. Morita teaches a composition in the form of nasal drops (Morita 4: 9-
11).
FF 16. Morita’s composition “comprises: (a) suspension particulates of one
or more water soluble polymers . . . and (b) a drug which can be locally
applied” (Morita 3: 3-7).
FF 17. Morita exemplifies the use of Eudragit L as a water soluble polymer
(Morita 3: 22-25 and 5: 20-34).
FF 18. Drugs that can be locally applied according to Morita’s disclosure
include anti-allergics, vasoconstrictors, and cortisone (a corticosteroid), as
well as, non-steroidal anti-inflammatories, anti-microbials, local anesthetics,
β-blockers, mydriatics, and anti-cataracts (Morita 3: 46-51).
FF 19. Morita teaches that additives conventionally used for aqueous
preparations can be added to the composition including:
(i) preservatives such as p-hydroxybenzoates, benzalkonium
chloride, chlorobutanol,
(ii) stabilizers such as sodium edetate, sodium citrate,
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(iii) suspending agents such as carboxymethylcellulose,
hydroxypropylcellulose,
(iv) isotonizers such as sodium chloride, sorbitol, glycerol,
(v) surface active agents such as polysorbate 80,
(vi) buffering agents such as sodium dihydrogen phosphate,
boric acid, citric acid, and
(vii) pH adjusting agents such as hydrochloric acid, acetic
acid, sodium hydroxide.

(Morita 4: 3-8.)

FF 20. Morita exemplifies a nasal drop composition comprising:
I. sodium cromoglycate (an anti-allergic),
II. Eudragit L (a water soluble polymer),
III. sodium edentate (a stabilizer),
IV. benzalkonium chloride (a preservative),
V. sodium dihydrogen phosphate (a buffering agent), and
VI. distilled water.

In addition, Morita teaches that the pH of this composition was
adjusted with hydrochloric acid.

(Morita 5: 20-34.)
FF 21. Appellants do not dispute that Morita teaches that the vehicle,
distilled water, is present in a concentration of at least 90% (m/V) of the
total composition.

PRINCIPLES OF LAW
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987). The test which determines whether an invention
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has been anticipated by a reference is whether the description of the
invention in the reference is “sufficient to put the public in possession of the
invention.” In re LeGrice, 301 F.2d 929, 933 (1962); In re Elsner, 381 F.3d
1125, 1128 (Fed. Cir. 2004) (following LeGrice, and noting that “[i]n
particular, one must be able to make the claimed invention without undue
experimentation.”).
A generic disclosure may anticipate a claim to a species within the
generic disclosure. E.g., In re Schaumann, 572 F.2d 312 (CCPA 1978). The
test for anticipation “is not an ‘ipsissimis verbis’ test.” In re Bond, 910 F.2d
831, 832 (Fed. Cir. 1990). Thus, a small genus can be a disclosure of each
species within the genus. In re Petering, 301 F.2d 676, 682 (CCPA 1962);
see also Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368,
1380 (Fed. Cir. 2001) (“[T]he disclosure of a small genus may anticipate the
species of that genus even if the species are not themselves recited.”).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

ANALYSIS
Claim 17 is representative of Appellants’ claimed invention and is
drawn to a liquid nasal pharmaceutical composition. The composition of
claim 17 comprises and therefore includes at least:
(a) an active substance such as an antiallergic, vasoconstrictor or
corticosteroid,
(b) sorbitol,
(c) a water-soluble C1-C4-alkyl-cellulose derivative such as
carboxymethylcellulose or hydroxypropylcellulose, and
(d) water present in an amount of at least 90% (m/V) of the total
composition.

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Morita’s teaches a composition in the form of nasal drops that
comprises, inter alia:
(i) an active substance such as an anti-allergic, vasoconstrictor, or
corticosteroid,
(ii) isotonizers such as sodium chloride, sorbitol, or glycerol,
(iii) suspending agents such as carboxymethylcellulose, or
hydroxypropylcellulose, and
(iv) water in a concentration of at least 90% (m/V) of the total
composition.

(FF 15-20.)
Appellants contend that Morita differs from their claimed invention
by teaching a composition that contains a water soluble polymer, e.g.,
“esters of dicarboxylic acid and hydroxyalkylcellulose and derivatives
thereof”, as well as, Eudragit L (App. Br. 3; FF 16, 17, and 20). This is not
persuasive. Appellants’ claimed invention uses the transitional term
comprising and therefore the claimed composition does not exclude a water
soluble polymer.
Appellants concede that Morita teaches a composition that contains
additives conventionally used for aqueous preparations, such as sorbitol and
carboxymethylcellulose or hydroxypropylcellulose (App. Br. 3-4; FF 19).
Nevertheless, Appellants contend that Morita’s additives “span[ ] seven
different categories of additive and encompass[ ] 17 different species (App.
Br. 3-4). In this regard, Appellants contend that Morita provides “[n]o
example [that] utilizes carboxymethylcellulose or hydro[xy]propyl-
cellulose”; “[n]o example [that] utilizes sorbitol”; and “[n]o teaching or
example [that] utilizes any combination of these, let alone in any particular
amounts” (App. Br. 4). This is not persuasive.
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The test is not whether the claimed invention is exemplified or
described using the same verbiage Appellants chose to describe the
invention. Cf. In re LeGrice, 301 F.2d at 933; In re Bond, 910 F.2d at 832.
Instead, the test is whether the description of the invention in the reference is
“sufficient to put the public in possession of the invention.” In re LeGrice,
301 F.2d at 933.
With regard to the seven different categories of additives taught by
Morita, Appellants’ claimed composition does not exclude the presence of
one or more agents from all seven of Morita’s additive categories (see FF
19). Further, Appellants’ contention regarding 17 different species accounts
for every agent in all seven of Morita’s additive categories. A closer
inspection reveals that Morita discloses between 1 and 3 species for each of
the seven categories of additives.
Accordingly, Morita teaches a composition that comprises, inter alia,
additives conventionally used for aqueous preparations (FF 19). There is no
persuasive evidence or argument on this record to support a conclusion that
a person of ordinary skill in this art would not have chosen an agent from
each of the seven categories of additives taught by Morita to be
conventionally used for aqueous preparations (id.). Therefore, Appellants’
contention regarding picking and choosing from among seven different
categories of additive agents is not persuasive. To include a single agent
from each of Morita’s seven categories of additives a person of ordinary
skill in the art, following the teachings of Morita, would select an agent from
the very small genus (i.e., 1-3 species) set forth in Morita for each category
of additive. A small genus can be a disclosure of each species within the
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genus. In re Petering, 301 F.2d at 682. There is no persuasive evidence or
argument on this record to support a conclusion that the genus of agents
listed in each of Morita’s additive categories is so large as to not anticipate
the invention of claim 17.
While Appellants contend that Morita fails to teach “any particular
amounts” of sorbitol and carboxymethylcellulose or hydroxypropylcellulose
(App. Br. 4), claim 17 does not require a particular amount of these agents to
be present in the composition.
Lastly, Appellants contend that Morita cannot anticipate claim 17,
which requires the composition to be a solution, because “Morita necessarily
contain particulates in suspension” (App. Br. 4). This is not persuasive.
Appellants provide no persuasive evidence or argument to support a
conclusion that a composition comprising particulates in suspension is not a
solution.

CONCLUSION OF LAW
The genus of isotonizers and suspending agents disclosed by Morita
as additives conventionally used for aqueous preparations is not so large as
to defeat a prima facie case of anticipation.
Therefore, I would affirm the rejection of claim 17 under 35 U.S.C.
§ 102(b) as being anticipated by Morita. Since they are not separately
argued, claims 1, 2, 5, 6, 9-16 and 18-20 would fall with claim 17.

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Obviousness:
Claims 1, 2, 5, 6, and 9-27 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Morita and Sengelmann.
Claims 1, 2, 4-6, and 9-27 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Morita and Fradis.
I agree with the Majority’s conclusion to affirm the rejections under
35 U.S.C. § 103(a).
For each ground of rejection, the claims are argued as a single group.
Accordingly, claim 17 is representative.
As discussed above, Morita anticipates claim 17. “[A]nticipation is
the epitome of obviousness.” Connell v. Sears, Roebuck & Co., 722 F.2d
1542, 1548, 220 USPQ 193, 198 (Fed. Cir. 1983). Accordingly, I would
affirm the rejection of claim 17 under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Morita and Sengelmann or the
combination of Morita and Fradis. Since they are not separately argued
claims 1, 2, 5, 6, 9-16, and 18-27 fall together with claim 17 over the
combination of Morita and Sengelmann and claims 1, 2, 4-6, 9-16, and 18-
27 fall together with claim 17 over the combination of Morita and Fradis.
To be complete, I recognize Appellants’ contention that “nothing in
Morita . . . teaches or suggests the use of applicants’ claimed cellulose
polymers in combination with sorbitol to improve the moisturizing
properties of a nasal composition” and that Fradis and Sengelmann do not
make up for this deficiency in Morita (App. Br. 5 and 6). There is, however,
no requirement in claim 17 that the composition exhibit moisturizing
properties. Further, as the Majority correctly points out “the reason for
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adding the sorbitol taught by the prior art need not be the same as that of
Appellants in order to render a claimed composition obvious” (Majority
Opinion 9).
In addition, I recognize Appellants’ contention that Morita’s “one
example directed to nasal drops, does not include either a suspending agent
or an isotonizer . . . [therefore,] Morita could fairly be interpreted to teach
away from the use of ‘suspending agents’ or ‘isotonizers’, or any
combination thereof, in nasal compositions” (App. Br. 5). This is not
persuasive.
Morita teaches suspending agents and isotonizers as additives
conventionally used for aqueous preparations (FF 19). There is no
persuasive evidence or argument on this record to support the contention that
Morita teaches away from the use of suspending agents and isotonizers in a
nasal composition simply because Morita did not exemplify a nasal
composition that included these conventionally used additives.

alw

FRANK A. SMITH
NOVARTIS CONSUMER HEALTH, INC.
200 KIMBALL DRIVE
OTC PATENT DEPARTMENT - 5TH FLOOR
PARSIPPANY, NJ 07054-0622