Ex Parte West

Board of Patent Appeals and Interferences

Sep 24, 2002

08790528 (B.P.A.I. Sep. 24, 2002)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 14

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DOUGLAS H. WEST
__________

Appeal No. 2000-1909
Application No. 08/790,528
__________

ON BRIEF
__________

Before ADAMS, MILLS, and GREEN, Administrative Patent Judges.

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 1-20. Claims 1 and 10 are representative of the claims
on appeal, and read as follows:
1. A masticatory for treating the multifactorial etiology of
gastroesophageal reflux disease comprising: a chewing-gum base, an acid
neutralizing agent, an anti-gas agent, and an acid production inhibitor.

10. A chewing-gum composition for treatment of the multifactorial etiology
of gastroesophageal reflux disease comprising: a chewing-gum
Appeal No. 2000-1909 Page 2
Application No. 08/790,528

integral with a chewable tablet, the chewable tablet including an acid
neutralizing agent, an anti-gas agent, and an acid production inhibitor.

The examiner relies upon the following references:
Beringer et al. (Beringer) 4,139,589 Feb. 13, 1979
Cherukuri et al. (Cherukuri) 4,971,787 Nov. 20, 1990
Singer et al. (Singer) 5,294,433 Mar. 15, 1994
Upson WO92/17161 Oct. 15, 1992
Caldwell WO95/05173 Feb. 23, 1995
France 0 349 103 Jan. 03, 1990
(European Patent )
Gottwald 0 322 048 June 28, 1989
(European Patent)

FDA Consumer (1995), p. 759, listing of product labeled “Tempo”

Drug Facts and Comparisons, (50th ed. 1996), Chapter 7, “Gastrointestinal
Drugs” pp. 1823-1891

Claims 1-9 and 19 stand rejected as obvious over the combination of
“Tempo” as set forth in FDA Consumer and Singer. Claims 10-20 stand rejected
as obvious over the combination of Caldwell, Gottwald, France or Upson and
Drug Facts and Comparisons, Beringer and Cherukuri. After careful review of
the record and consideration of the issues before us, we reverse both rejections.
DISCUSSION
Claims 1-9 and 19 stand rejected under 35 U.S.C. § 103(a) as being
obvious over the combination of “Tempo” as set forth in FDA Consumer and
Singer. The rejection is set forth in relevant part below.
FDA Consumer, 1995 sets forth a product marketed under
the trade name “Tempo” which comprises calcium carbonate, an
antacid, and simethicone, an anti-flatulent, in a chewable matrix for
the treatment of gastroesophageal disorders. Singer [ ] discloses
H-2 antagonists in a chewing gum base. . . . Singer indicates that
H-2 antagonists are well known in the art for the treatment for
esophagitis through the inhibition of acid production. . . . Singer
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Application No. 08/790,528

discloses the H-2 antagonists can be incorporated into a chewing
gum matrix and are released from said matrix. The antacid and
anti-flatulent are ingredients well known and often used in the
treatment of acid reflux or GERD, as set forth previously. H-2
antagonists are also well known for use in the treatment of acid
reflux or GERD. The court has determined that the combination of
two or more ingredients known in the art for the same uses is
obvious, and unpatentable. (In re Kerkhoven 205 USPQ 1069
(CCPA 1980)) which states: “It is prima facie obvious to combine
two compositions each of which is taught by prior art to be useful
for same purpose in order to form [a] [sic] third composition that is
to be used for very same purpose; idea of combining them flows
logically from their having been individually taught in prior art . . .”)
It would have been obvious to one of ordinary skill in the art at the
time the invention was made to have combined the acid production
inhibitor of Singer with the antacids and antiflatulents of
composition marketed as Tempo, as it would lead to a longer term
inhibition of acid production, in combination with the quick acid
relief provided by the antacids and the anti-flatulent.

Examiner’s Answer, pages 4-5.
Appellant argues that there is no motivation to combine Singer with the
composition marketed as Tempo. Appellant asserts that while Singer teaches
the use of H-2 antagonists in a chewing gum matrix for the treatment of gingivitis,
Singer teaches the use of the chewing gum matrix as a topical carrier that is
expectorated rather than be swallowed. Thus, appellant argues there is no
motivation to combine a product that is chewed and not swallowed, i.e., the
chewing gum of Singer, with a product that is to be swallowed, i.e.. the Tempo
composition. See Appeal Brief, pages 4-6.
The burden is on the examiner to set forth a prima facie case of
obviousness. See In re Alton, 76 F.3d 1168, 1175, 37 USPQ2d 1578, 1581
(Fed. Cir. 1996). With respect to an obviousness rejection based on a
combination of references, as the court has stated, “virtually all [inventions] are
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Application No. 08/790,528

combinations of old elements.” Environmental Designs, Ltd. V. Union Oil Co.,
713 693, 698, 218 USPQ 865, 870 (Fed. Cir. 1983); see also Richdel, Inc. v.
Sunspool Corp., 714 F.2d 1573, 1579-80, 219 U.S.P.Q. (BNA) 8, 12 (Fed. Cir.
1983) (“Most, if not all, inventions are combinations and mostly of old
elements.”). Therefore, an examiner may often find every element of a claimed
invention in the prior art. If identification of each claimed element in the prior art
were sufficient to negate patentability, very few patents would ever issue. The
United States Court of Appeals for the Federal Circuit, our reviewing court,
however, has stated that “the best defense against hindsight-based obviousness
analysis is the rigorous application of the requirement for a showing of a teaching
or motivation to combine the prior art references.” Ecolochem, Inc. v. Southern
California Edison Co., 227 F.3d 1361, 1371, 56 USPQ2d 1065, 1073 (Fed. Cir.
2000).
In this situation, the rejection fails to show that one of ordinary skill in the
art would have been motivated to incorporate an acid neutralizing agent, an anti-
gas agent, and an acid production inhibitor in a chewing gum base. Singer
teaches the incorporation of an acid-production inhibitor, i.e., an H-2 receptor
antagonist, in a chewing gum to deliver the antagonist to the oral cavity for the
treatment of gingivitis. Singer, however, provides no motivation to add the acid
neutralizing base and an anti-gas agent to the chewing gum matrix because
Singer only teaches the use of the chewing gum to deliver an active agent to the
oral cavity for the treatment of gingivitis, and does not teach or suggest its use
for the delivery of active agents for the treatment of gastroesophageal reflux
Appeal No. 2000-1909 Page 5
Application No. 08/790,528

disease. While FDA Consumer teaches the combination of an acid neutralizing
agent and an anti-gas agent in a chewable tablet for the treatment of
gastroesophageal reflux disease, it also provides no teaching or suggestion for
incorporating the active agents into a chewing gum matrix. Thus, the examiner
has failed to set forth a prima facie case of obviousness.
Claims 10-20 stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Caldwell, Gottwald, France or Upson and Drug Facts
and Comparisons, Beringer and Cherukuri.
According to the rejection, Caldwell, Gottwald, France and Upson each
teach a chewable tablet comprising an H-2 receptor antagonist, i.e., an acid
production inhibitor, and an acid neutralizing agent. Drug Facts and
Comparisons is relied upon for teaching chewable tablets comprising a
hydroxide or carbonate antacid, i.e., an acid neutralizing agent, and simethicone,
i.e., an anti-gas agent. The answer reasons that
[a]s both acid-production inhibitors in combination with antacids
and antiflatulents in combination with antacids have been shown to
be well known for use in chewable tablets for the treatment of
gastroesophageal disorders, it is expected, absent unexpected
results, that a tablet comprising all three ingredients would also be
useful in the treatment of gastroesophageal disorders. The court
has determined that the combination of two or more ingredients
known in the art for the same uses is obvious, and unpatentable.
(In re Kerkhoven 205 USPQ 1069 (CCPA 1980)) which states: “It is
prima facie obvious to combine two compositions each of which is
taught by prior art to be useful for same purpose in order to form [a]
[sic] third composition that is to be used for very same purpose;
idea of combining them flows logically from their having been
individually taught in prior art . . .”)

Examiner’s Answer, pages 6-7.
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Application No. 08/790,528

The rejection relies upon Beringer for teaching “the standard methods of
making tablets that are encased by gum, as well as methods of making gum
encased by a chewable tablet for the administration of a pharmaceutically active
agent.” Id. at 7. Cherukuri is cited for teaching chewing gums that incorporate
antacids, as well as disclosing “the many sweeteners, and flavoring agents
useful in the production of a medicated gum.” Id. The rejection concludes that
[i]t would have been obvious to one of ordinary skill in the art at the
time the invention was made to have added an antiflatulent to the
chewable tablets of Caldwell, Gottwald, France or Upson, as both
the antiflatulents and the combinations thereof with antacids and
acid production inhibitors in a chewable form were well known in
the art at the time the invention was made for the treatment of
gastroesophageal disorders, as listed by Drug Facts and
Comparisons. It would have further been obvious to have added
an integral chewing gum through the methods of Beringer or
Cherukuri, as such multi zone delivery compositions were well
known in the art and they allowed the incorporation of different
pharmaceuticals.

Id. at 7-8.

Appellant argues that the references relied upon by the examiner do not
provide any motivation to provide a chewable tablet containing an antacid, an
anti-gas agent and a H-2 receptor antagonist integral with a chewing gum matrix.
We agree.
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Application No. 08/790,528

The rejection states that it would have been obvious “to have added an
integral chewing gum through the methods of Beringer or Cherukuri, as such
multi zone delivery compositions were well known in the art and they allowed the
incorporation of different pharmaceuticals.” Examiner’s Answer, pages 7-8.
While it may have been known that pharmaceuticals may be incorporated into a
multi-zone delivery device, the rejection does not address why the ordinary
artisan would have been motivated to place all of the active ingredients in a
chewable tablet, and then add a chewing-gum integral with the chewable tablet.
Specifically, if all of the active ingredients were placed in a chewable tablet, the
rejection does not address why one of ordinary skill in the art at the time the
invention was made would have been motivated to add a chewing-gum integral
with the chewable tablet, which already contains all of the active ingredients.
See In re Lee, 277 F.3d 1338, 1342, 61 USPQ2d 1430, 1432 (Fed. Cir. 2002) (in
reviewing an obviousness rejection, the court noted that “conclusory statements”
as to teaching, suggestion or motivation to arrive at the claimed invention “do not
adequately address the issue.”).
Moreover, the examiner has ignored certain teachings of the prior art
references that would lead one away from the claimed invention. Obviousness is
not based on isolated teachings in the art, but is determined in view of the sum
of all of the relevant teachings in the art. See In re Kuderna, 426 F.2d 385, 389,
165 USPQ 575, 578 (CCPA 1970); see also In re Shuman, 361 F.2d 1008, 1012,
150 USPQ 54, 57 (CCPA 1966). For example, Caldwell teaches that the use of
an effervescent tablet to deliver a H-2 antagonist reduces the bioavailability of
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Application No. 08/790,528

the active ingredient. See Caldwell, page 2, first full paragraph. Gottwald
teaches that H-2 antagonists, such as cimetidine, have a very bitter taste, and
thus they are usually administered as a tablet. Moreover, Gottwald also teaches
that a tablet containing the antagonist should release the active ingredient rapidly
and completely upon reaching the stomach. See Gottwald, page 3, lines 5-23.
In addition, France teaches that H-2 receptor antagonists are bitter, and thus
have palatability problems. See France, page 2. These disclosures thus teach
away from placing an H-2 receptor antagonist integral with a chewing gum matrix
because of the problems of bioavailability of the antagonist, as well as its bitter
taste, which, as noted by France, would reduce patient compliance.
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Application No. 08/790,528

CONCLUSION
As the rejections under 35 U.S.C. § 103(a) fail to set forth a prima facie
case of obviousness, they are reversed.

REVERSED

Donald E. Adams )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Greeen )
Administrative Patent Judge )

LG/dym

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Application No. 08/790,528

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