Ex Parte Luzzatti

Board of Patent Appeals and Interferences

Apr 27, 2010

10079569 (B.P.A.I. Apr. 27, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RENZO LUZZATTI
__________

Appeal 2009-010552
Application 10/079,569
Technology Center 1600
__________

Decided: April 27, 2010
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
formulations for treating a gastrointestinal disorder, including
gastroesophageal reflux disease. The Patent Examiner rejected the claims
for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-
in-part.
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STATEMENT OF THE CASE
Claims 1-6, 8, 11-14, 16-39, 92, 93 and 96 are on appeal.1 Claims 1
and 96 are illustrative of the subject matter and read as follows:
1. A formulation for treating a gastrointestinal disorder comprising:
a1) a locally acting anesthetic, and
b1) an antacid,
said formulation provided in a therapeutically effective amount to
treat a gastrointestinal disorder.

96. A formulation to treat gastroesophageal reflux disease (GERD)
comprising:
a1) a locally acting anesthetic, and
b1) an antacid,
said formulation provided in a therapeutically effective amount to
treat GERD.

We are told that Appellant elected calcium carbonate for examination
as the claimed “b1)” antacid. (Ans. 12.) The Examiner rejected the claims
as follows:
• claims 1-6, 8, 11-14, 16-26, 32-39, 92, 93 and 96 under 35 U.S.C.
§103(a) as unpatentable over Norling2 and Matthias;3 and
• claims 1-4, 8, 13, 14, 16 and 27-31 under 35 U.S.C. § 103(a) as
unpatentable over Witt4 and Matthias.
OBVIOUSNESS
The Issues
A. The Rejection over Norling and Matthias

1 Claims 7, 9, 10, 15, 40-75, 94 and 95 were withdrawn from consideration
and claims 76-91 and 97 were canceled. (App. Br. 5.)
2 US 5,958,458, issued to Tomas Norling et al., Sep. 28, 1999.
3 US 4,917,894, issued to Joseph A. Matthias et al., Apr. 17, 1990.
4 US 6,350,438 B1, issued to Jonathan James Witt et al., Feb. 26, 2002.
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The Examiner’s position is that Norling taught formulations
comprising calcium carbonate and benzocaine (a local anesthetic), but not
dyclonine, and that Norling did not teach the amount of benzocaine to use.
(Ans. 3-4.) However, the Examiner found that deficiency remedied by
Matthias, which taught lozenges containing 2-15mg benzocaine and 1-3mg
dyclonine per dose. (Id. at 4.) The Examiner found that Norling’s teaching
to combine calcium carbonate and a local anesthetic such as benzocaine
motivated those of ordinary skill in the art to do so, and concluded that such
formulations containing local anesthetic in the amounts taught by Matthias
would have been obvious. (Id. at 4-5.) The Examiner concluded that it
would have been obvious to optimize formulation amounts of benzocaine,
dyclonine and calcium carbonate based on the combined teachings of
Norling and Matthias. (Id. at 5.)
Appellant contends that “Norling provides no reason why one would
specifically formulate the combination of a local anesthetic on a core
(containing calcium carbonate) out of the myriad of thousands of potential
combinations and permutations and then do so in a ‘therapeutically effective
amount.’” (App. Br. 30, emphasis deleted.) Further, “Norling does not
discuss treating a gastrointestinal disorder or even treating GERD.” (Id. at
31, emphasis deleted.) According to Appellant, “[t]here is no sound reason
articulated in the Final Office Action as to why one of ordinary skill in the
art would have wanted to substitute the Matthias amounts of benzocaine for
those of Norling.” (Id. at 34, emphasis deleted.) Further, “there is no
disclosure, teaching or suggestion in Norling (with or without Matthias) that
the Norling core would or could have accommodated the requisite amount of
CaCO3 that would have been ‘therapeutically effective’ for treating a
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gastrointestinal disorder.” (Id. at 35, emphasis deleted.) In Appellant’s
view, because neither Norling nor Matthias taught treating a gastrointestinal
disorder, the prior art provided no guidance to an effective amount for
treating such a disorder. (Id. at 35-36.)
The issue with respect to this rejection is whether the evidence
supports the Examiner’s conclusion that a formulation comprising the
combined calcium carbonate and benzocaine taught Norling and Matthias
would have been effective to treat a gastrointestinal disorder.

B. The Rejection over Witt and Matthias
The Examiner’s position is that Witt taught oral care lozenges that
included calcium carbonate as a dental abrasive. (Ans. 5.) The Examiner
also found that Witt taught including benzocaine, saccharin and cimetidine
in the lozenge, and found that one of ordinary skill in the art would have
been motivated to include each of these ingredients. (Id. at 5-6.) While Witt
did not teach specific amounts of the components including benzocaine, the
Examiner found the deficiency remedied by Matthias. (Id. at 6.) Based on
the combined teachings of Witt and Matthias, the Examiner concluded that it
would have been obvious to formulate a lozenge with 2-15mg benzocaine
and 30% calcium carbonate as abrasive. (Id.)
Appellant contends that Witt concerns compositions containing the
chlorite ion for treating localized conditions of the oral cavity. (App. Br. 74-
75.) According to Appellant, the rejection did not establish the equivalence
of 30% silica abrasive and 30% calcium carbonate abrasive, nor that 30%
silica would equate to a therapeutically effective amount of calcium
carbonate. (Id. at 76.)
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The issue with respect to this rejection is whether it would have been
obvious to combine Witt’s calcium carbonate abrasive with Matthias’
benzocaine in such a way that would have produced a formulation effective
to treat a gastrointestinal disorder.

Findings of Fact
1. Norling described a general purpose pharmaceutical formulation in
the form of a core comprising an inert carrier and an active substance.
(Norling, col. 2, ll. 8-22.)
2. Norling taught that calcium carbonate was a suitable inert carrier. (Id.
at col. 5, ll. 8-15.)
3. Norling taught that the formulation was suitable for a variety of active
substances including “local anaesthetics such as, e.g., lidocaine,
prilocaine, benzocaine, and the like.” (Id. at col. 7, ll. 17-18.)
4. Norling described a working example formulation comprising calcium
carbonate (11.4 kg) with theophylline (3.0 kg). (Id. at col. 23, ll. 30.)
5. Matthias described “rapid-onset long-duration” oral anesthetic
compositions. (Matthias, col. 1, ll. 5-8.)
6. Matthias provided a table listing seven oral anesthetics, including
benzocaine and dyclonine hydrochloride, with dosages said to be
approved as safe and effective by the FDA. (Id. at col. 1, ll. 22-32.)
7. Matthias’ table lists dosages for solid forms of benzocaine and
dyclonine hydrochloride as 2-15 mg per dose and 1-3 mg per dose,
respectively. (Id.)
8. Matthias disclosed: “[w]hile [the listed] anesthetics are all effective,
they sharply differ in their action. Thus, we have found that dyclonine
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hydrochloride gradually and slowly reaches its maximum activity,
e.g., in about 30 minutes, whereas the other anesthetic agents rapidly
reach their maximum activity, e.g. within about five minutes or less.”
(Id. at col. 1, ll. 34-39.)
9. Matthias further disclosed: “we have also found that while dyclonine
hydrochloride provides long-lasting anesthetic activity, e.g. for about
60 minutes, the rapid-onset anesthetics lose their anesthetic activity
much sooner, e.g. within about 20-30 minutes or less.” (Id. at col. 1,
ll. 40-44.)
10. Matthias taught a composition comprising a rapid-onset anesthetic,
such as benzocaine, with a long-duration anesthetic of “formula (I)”
(i.e., dyclonine compounds), and described the combination as “an
oral anesthetic composition that provides both rapid-onset of
anesthetic effect and a long duration of anesthetic effect.” (Id. at col.
1, ll. 45-64.)
11. Matthias taught: “when benzocaine is used together with compound
(I), e.g. dyclonine hydrochloride, in the present invention, an
anhydrous pharmaceutically acceptable carrier will be generally
employed.” (Id. at col. 3, ll. 19-22.)
12. Matthias further taught: “the compound and the rapidonset [sic]
anesthetic agent may be combined in a conventional manner with a
desired solid or liquid, anhydrous or aqueous pharmaceutically
acceptable carrier, in order to provide a solid or non-solid
composition.” (Id. at col. 3, ll. 25-29.)
13. Witt described “topical oral compositions, including therapeutic
rinses, especially mouth rinses, as well as toothpastes, gels, tooth
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powders, chewing gums, mouth sprays, lozenges (including breath
mints), dental implements (such as dental floss and tape), and pet care
products comprising at least a minimally effective amount of chlorite
ion.” (Witt, Abstract.)
14. Witt taught using dental abrasives as carriers, including silicas,
insoluble sodium polymetaphosphate, hydrated alumina, calcium
carbonate, and others. (Id. at col. 11, ll. 3-17.)
15. Witt taught: “[s]ilica dental abrasives of various types are preferred
because of their unique benefits of exceptional dental cleaning and
polishing performance.” (Id. at col. 11, ll. 27-30.)
16. Witt taught: “[t]he total amount of abrasive in dentifrice compositions
of the subject invention preferably range from about 6% to about 70%
by weight; toothpastes preferably contain from about 10% to about
50% of abrasives, by weight of the composition.” (Id. at col. 11, ll.
61-65.)
17. Witt taught: “numbing agents can be used as optional ingredients.”
(Id. at col. 14, ll. 19-20.)
18. Witt taught: “[p]referred numbing agents include benzocaine,
lidocaine, clove bud oil, and ethanol.” (Id. at col. 14, ll. 48-49.)

Principles of Law
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006). “The combination of familiar elements according to
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known methods is likely to be obvious when it does no more than yield
predictable results.” KSR, 550 U.S. at 416.

Analysis
A. The Rejection over Norling and Matthias
Appellant indicates that each claim on appeal should be considered
separately. (App. Br. 26.)
Claim 1
We find that Norling taught a general purpose pharmaceutical
formulation. Norling taught that an inert core of calcium carbonate, which
happens to be an antacid, could serve as a vehicle for a wide variety of
drugs, including benzocaine and others. Norling explicitly taught that the
inert core type formulation would have wide applicability. Appellant argues
that while Norling taught so many possible uses for the formulation (“an
extensive laundry list”) including delivering local anesthetic, Norling did not
give a reason to deliver local anesthetic with calcium carbonate. (App. Br.
27-30.) We think this argument misses Norling’s point. The drugs Norling
listed for delivery were already known as useful pharmaceuticals. Those in
the art already had reasons to deliver them – Norling provided a generally
applicable way of delivering them. We agree with the Examiner that a
person of ordinary skill in the art would have thought it obvious to apply
Norlings’ teachings to delivering Matthias’ local anesthetics. As Matthias
taught a combination of benzocaine with dyclonine hydrochloride, and
taught the amount of each to use, we agree that formulations containing
those doses with calcium carbonate would have been obvious.
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Claim 1 requires that the formulation provide “a therapeutically
effective amount to treat a gastrointestinal disorder.” Appellant argues that
the Examiner ignored that limitation. We disagree. The Examiner showed
that amounts of antacid and local anesthetic recited in Appellant’s dependent
claims overlapped the amounts of each that Norling and Matthias taught.
(Ans. 9-11.) That is, if a person of ordinary skill in the art combined the
teachings of Norling and Matthias as suggested by Norling, the resulting
formulation would have been the formulation Appellant now claims. To the
extent Appellant is arguing that the calcium carbonate alone must be present
in an effective amount (App. Br. 32), the claim is written so that either or
both components supply the effect. In any event, we find the Examiner’s
evidence and explanation account for any interpretation.
Appellant also argues that the Examiner erred by not giving patentable
weight to claim 1’s preamble terms “[a] formulation for treating a
gastrointestinal disorder.” We agree with the Examiner that because the
prior art suggested a formulation having definite amounts of calcium
carbonate and benzocaine that would have been effective to treat a
gastrointestinal disorder, claim 1’s preamble does not patentably distinguish
over the prior art. The intended use does not provide a further “structural”
distinction from the obvious formulation. See Ans. 11.
Appellant finds it significant that neither reference discussed
gastrointestinal disorders. (App. Br. 35-36.) The evidence shows that the
prior art suggested a formulation having amounts of calcium carbonate and
local anesthetic that Appellant now describes as effective for treating
gastrointestinal disorders. The intended use does not make the obvious
formulation patentable.
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Claims 2-6, 8, 11, 12, 14, 16, 17, 32, 33 and 39
In the arguments addressing each of claims 2-6, 8, 11, 12, 14, 16, 17,
32, 33 and 39, Appellant merely reproduces the claim, and in some cases
also names a particular feature recited in the claim. (Id. at 36-65.) For all of
these claims, Appellant argues that the alleged deficiencies of the references
as applied to claim 1 “apply equally well” and “Applicant’s prior remarks . .
. are equally applied . . . without having to repeat the same.” (Id. at 37.) We
find those statements insufficient to qualify as separate arguments because
“[a] statement which merely points out what a claim recites will not be
considered an argument for separate patentability of the claim.” 37 C.F.R.
§ 41.37(c)(1)(vii). These claims fall with claim 1 because they were not
separately argued.

Claim 13
Appellant objects that the Final Office Action did not address claim
13’s limitation “wherein said antacid (b1) is an alkaline buffering agent.”
(App. Br. 42.) Appellant points to the Specification’s definition of “alkaline
buffering agent” to mean “a compound which contains at least one hydroxyl
group.” (Id., citing Spec. at [0018], [sic, 3:[13]].) The Examiner responds
that Appellant elected calcium carbonate as the b1) antacid to be examined,
and that Appellant indicated that calcium carbonate “read on instant claim 1-
40 and 92-95.” (Ans. 12.) Appellant’s Reply Brief does not dispute the
Examiner’s account.
The Examiner reasons that because the prior art taught calcium
carbonate “it would necessarily read on instant claim 13.” (Id.) We
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disagree. Calcium carbonate (CaCO3) does not have at least one hydroxyl
group, and is not an “alkaline buffering agent” according to the
Specification’s definition. Claim 13 interpreted in light of the Specification
is not directed to calcium carbonate as the b1) antacid, notwithstanding the
contrary statement attributed to Appellant. Although claim 13 might
properly have been withdrawn from examination under the regulations, it
was instead examined. As the claim was examined and rejected, the appeal
from the rejection is before us for decision. We reverse the rejection
presented for claim 13 because it did not account for the “alkaline buffering
agent” interpreted in light of the Specification.

Claims 18-22
Appellant argues that neither Norling nor Matthias specified or
suggested that the local anesthetic should be “from about 0.01% to about
50% by weight” (claim 18); “from about 0.1% to about 2.5% by weight”
(claim 19); “from about 0.25% to about 10% by weight” (claim 20); “from
about 0.5% to about 5% by weight” (claim 21); and “from about 1% to about
2% by weight” (claim 22). (App. Br. 47-52.)
The Examiner calculates that the incorporation of 2-15mg benzocaine
as taught by Matthias into one of Norling’s 1200mg tablets would result in a
formulation having about 0.2% to 1.25% local anesthetic. (Ans. 9.) The
calculation appears correct on its face, and Appellant does not dispute it in
the Reply Brief. The calculation evidences that the prior art suggested a
formulation range within or overlapping all the recited ranges in claims 18-
22. The evidence supports the conclusion of obviousness.

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Claims 23-26
Appellant argues that neither Norling nor Matthias specified or
suggested that the antacid is provided in an amount “from about 1 mEq to
about 50 mEq” (claim 23); “from about 5 mEq to about 40 mEq” (claim 24);
“from about 10 mEq to about 30 mEq” (claim 25); and “from about 15 mEq
to about 25 mEq” (claim 26). (App. Br. 52-56.)
According to Appellant, “1 mEq of calcium carbonate (CaCO3) is
equivalent to ~50 mg so that ~1-60 mEq CaCO3 equates to ~50-3,000 mg
CaCO3 . . . .” (App. Br. 35.) The Examiner found that Norling described a
working example tablet containing about 76 mg calcium carbonate. (Ans.
10.) Given Norling’s disclosure, we agree with the Examiner determining
the amount of calcium carbonate for a dosage was within the level of skill in
the art.

Claims 34-38
Appellant argues that the rejection “does not even address the feature
of such a bioadhesive that ‘binds to the lining of the gastrointestinal tract’”
and features recited in claims 35-38. (App. Br. 58-63.) We disagree. The
Examiner specifically found that Norling taught using polymethyl
methacrylate in the formulation.
The Examiner explains that Appellant elected a vinyl and an acrylic
derivative as the bioadhesive to be examined. (Ans. 12.) The Examiner
found that Norling taught polymethyl methacrylate as a polymer used for
release coatings (Ans. 3), and that Appellant’s Specification identified
polymethylacrylate as a suitable vinyl acrylic derivative (id. at 12). The
Examiner reasoned that because “binding to the lining of the gastrointestinal
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tract is a property of the polymer, the polymer taught by Norling et al, would
necessarily meet the limitation of instant claim 34.” (Id. at 12-13.) The
Examiner applied the same reasoning to the bioadhesive properties recited in
claims 35-38: “as these are all properties of the polymer and the polymer
taught by Norling et al. is indicated in the instant [S]pecification as a
particular species of that elected in which [A]pplicant indicated that these
polymers read on instant claims 1-75 and 92-95.” (Id. at 13.)

Claims 92 and 93
Appellant argues that the rejection did not address the fact that claim
92 uses the transitional phrase “consisting essentially of” (App. Br. 65), and
did not address the “consisting of” transitional phrase in claim 93 (id. at 66).
The Examiner concluded that a formulation comprising calcium
carbonate and benzocaine would have been obvious. Because no other
ingredients were mentioned, the conclusion was effectively that a
composition consisting of calcium carbonate and benzocaine would have
been obvious. We find no evidence of Examiner error.

Claim 96
Appellant argues that claim 96 recites a “therapeutically effective
amount to treat GERD,” but the rejection fails to address that feature. (App.
Br. 68.) It is Appellant’s burden to show that the amount of calcium
carbonate taught by Norling and the amounts of benzocaine or dyclonine
taught by Matthias would not have been effective to treat GERD when
combined as suggested. Appellant made no such showing, and has not even
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alleged that the amounts taught by the prior art would not have been
effective.

B. The Rejection over Witt and Matthias
The rejection rests on the finding that Witt taught formulating
lozenges with an abrasive. Witt taught formulating dentifrices and
toothpastes with abrasives. (FF16.) We do not find a direct teaching by
Witt to put abrasives in anything other than dentifrices or toothpaste.
Reading Witt’s disclosure as a whole, we do not find a fair suggestion to
formulate a lozenge with an abrasive. We find the evidence of record does
not support the case for obviousness as presented over Witt and Matthias.

CONCLUSIONS
The evidence of record supports the case for obviousness over Norling
and Matthias.
The evidence of record does not support the case for obviousness as
presented over Witt and Matthias.

SUMMARY
We affirm the rejection of claims 1-6, 8, 11-14, 16-26, 32-39, 92, 93
and 96 under 35 U.S.C. §103(a) as unpatentable over Norling and Matthias.
We reverse the rejection of claim 13 under 35 U.S.C. §103(a) as
unpatentable over Norling and Matthias.
We reverse the rejection of claims 1-4, 8, 13, 14, 16 and 27-31 under
35 U.S.C. § 103(a) as unpatentable over Witt and Matthias.
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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

alw

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