Ex Parte Uemura et al

Patent Trial and Appeal Board

Apr 29, 2016

11989030 (P.T.A.B. Apr. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111989,030 01/18/2008
127226 7590 05/03/2016
Birch, Stewart, Kolasch & Birch, LLP
P.O. Box 747
Falls Church, VA 22040-0747
FIRST NAMED INVENTOR
Katsuji Uemura
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
0283-0263PUS 1 3392
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
05/03/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
mailroom@bskb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KA TSUJI UEMURA, MASAAKI SUGIMOTO,
SHINY A TAKATSUKA, and TOSHINOBU KOMORI1
Appeal 2013-011057
Application 11/989,030
Technology Center 1600
Before LORA M. GREEN, JOHN G. NEW, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1Appellants state the real party-in-interest is Mitsubishi Tanabe Pharma
Corporation. App. Br. 1.
Appeal 2013-011057
Application 11/989,030
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 7-16 and 23-25. Specifically, claims
7-9, 11-16, and 25 stand rejected as unpatentable under 35 U.S.C. § 103(a)
as being obvious over the combination of Ohkouchi et al. (US 6,740,339 Bl,
May 25, 2004) ("Ohkouchi") and Sugimoto et al. (US 2004/0109890 Al,
June 10, 2004) ("Sugimoto").
Claim 10 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Ohkouchi, Sugimoto, and Kajiyama
(WO 2002/02083 Al, January 10, 2002) ("Kajiyama").2
Claims 23 and 24 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Ohkouchi, Sugimoto, and
Onuki et al. (US 2004/0147605 Al, July 29, 2004) ("Onuki").
Claims 7-9, 11-13, 15, 16, and 25 also stand provisionally rejected as
unpatentable under the nonstatutory doctrine of obviousness-type double
patenting over claims 17-20 of co-pending Sugimoto et al. (Appl. No.
10/468,208) ("the '208 application")3 and Ohkouchi.
Claim 10 also stands provisionally rejected as unpatentable under the
nonstatutory doctrine of obviousness-type double patenting over claims 17-
20 of the '208 application and Kajiyama.
2 Although the Examiner, in the Final Office Action, states that a certified
English translation of the Abstract of this publication was submitted by
Appellants in their information disclosures, submitted January 18, 2008, it is
missing from the record. See Final Act. 9. However, because Appellants do
not argue claim 10 separately, or otherwise rely upon the teachings of
Kajiyama in their appeal, we need not address the issue of this imperfection
in the record.
3 The '208 application issued as US 7,927,623 B2 on April 19, 2011.
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Claim 14, 23, and 24 also stands provisionally rejected as
unpatentable under the nonstatutory doctrine of obviousness-type double
patenting over claims 17-20 of the '208 application and Ohkouchi and
Onuki.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' claimed invention is directed to a method of suppressing
the bitter taste of a drug when a rapidly disintegrating tablet in an oral cavity
is produced. Abstract. When a rapidly disintegrating tablet in an oral cavity
is produced, the bitter taste of a drug is suppressed by utilizing (a) a granule
which contains a drug having a bitter taste and an excipient and in which the
bitter taste has not been suppressed and (b) a granule containing a water
soluble saccharide. Id.
REPRESENTATIVE CLAIM
Claim 7 is representative of the claims on appeal and recites:
7. A method of producing a rapidly disintegrating
tablet in an oral cavity, in which tablet a bitter taste of a drug is
suppressed, comprising the following steps:
( 1) a step of mixing (a) a granule which contains a drug
having a bitter taste and an excipient and in which the bitter taste
has not been suppressed and (b) a granule containing a water
soluble saccharide which is insoluble in an alcohol based solvent
and a binder which is soluble in water and in an alcohol based
solvent,
(2) a step of compression-molding the mixture of (1), and
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Application 11/989,030
(3) a step of treating the compression-molded product of
(2) with an alcohol based solvent.
App. Br. App'x A 3.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are prima facie obvious over the cited prior art
references. We address the arguments raised by Appellants on appeal
below.
A. Claims 7-16 and 25 under 35 U.S.C. § 103(a)
Issue
Appellants argue the Examiner erred by impermissibly employing
hindsight analysis and misinterpreting the prior art in concluding the claims
are obvious over the combined cited prior art. App. Br 6.
ANALYSIS
Appellants argue the Examiner impermissibly and arbitrarily selected
the various teachings of Ohkouchi and Sugimoto, without providing any
rationale or basis as to why a person of ordinary skill in the art would have a
reasonable expectation of success in combining the references. App. Br. 6.
Specifically, Appellants contend that, contrary to the Examiner's conclusion
that it would be obvious to select diphenhydramine as a substitute for the
active ingredient of Ohkouchi' s Example 8, diphenhydramine is just one of
many potential active ingredients taught by Ohkouchi and there would be no
obvious reason to select it. Id. Appellants also dispute the Examiner's
conclusion that that it would be obvious to add hydroxypropyl cellulose
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Application 11/989,030
(HPC) to granule H, which does not contain the active ingredient, in the
same Example. Id.
Appellants also disagree with the Examiner's finding that it would be
obvious to apply the step of treating the tablets with ethanol, as taught by
Sugimoto because the Examiner has overlooked or ignored other technical
features taught by Ohkouchi and Sugimoto. App. Br. 6. By way of
example, Appellants argue that Ohkouchi teaches using a saccharide or
sugar alcohol with a large particle diameter and a saccharide or sugar
alcohol with a small particle diameter. Id. at 7. Appellants state that
moldability is thus improved when dry tableting even under a low
compression pressure. Id. (citing e.g., Spec. iJ 7). However, Appellants
contend, Ohkouchi teaches it is not necessary to employ two kinds of
granules; in the fifteen working examples and three comparative examples
taught by Ohkouchi, only Examples 2--4 and 8 use two kinds of granules.
Id.
Appellants also dispute the Examiner's finding that Ohkouchi teaches
that cellulose compounds include crystalline cellulose and hydroxypropyl
cellulose and that, in two exemplary embodiments, the cellulose compound
may be included in the particle which does not contain the active ingredient.
App. Br. 7 (citing Ohkouchi col. 3, 11. 2-4; Ex. 4). Appellants contend,
however, that the cellulose compound disclosed in column 3, lines 2-4 of
Ohkouchi is not hydroxypropyl cellulose ("HPC"), but is, rather, low-
substituted hydroxypropyl cellulose ("L-HPC"). Id. Appellants assert that
L-HPC is insoluble in water, whereas HPC is water soluble. Id. at 7-8
(citing Shin-Etsu Chemical Co., Low Substituted Hydroxypropyl Cellulose
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NF: L-HPC, 5 (no date provided)). 4 Appellants also assert HPC is typically
used as a granulation binder in aqueous solutions, but L-HPC cannot be
employed in this manner. Id. at 8. Appellants further state L-HPC, but not
HPC, is an effective disintegrant because it swells in water. Id. Therefore,
Appellants argue, HPC and L-HPC are distinguishable from each other in
the art, and the Examiner's conclusion that it would be obvious to one
skilled in the art to choose HPC as the cellulose compound in the particle not
containing the active ingredient in Example 8 is based on a misinterpretation
of the cited art. Id. (citing Ohkouchi Ex. 8; Final Act. 8).
Appellants next argue that, in Example 8 of Ohkouchi, crystalline
cellulose is added after combining granule G and granule H and in Example
4, the crystalline cellulose is included in the granule that does not contain the
active ingredient. App. Br. 8. Appellants contend that, in the context of the
teaching of Ohkouchi that moldability is improved when dry tableting, even
under a low compression pressure, and the good compressibility of
crystalline cellulose, the crystalline cellulose used in the Examples should be
the same cellulose compound described in claim 1 of Ohkouchi. Id.
Finally, Appellants argue that the teachings of Ohkouchi reveal "an
excellent invention has been completed." App. Br. 9. In other words,
Appellants argue, "it is not appropriate to interpret [the teachings of
Ohkouchi] to mean the completed invention still needs further
improvement." Id. Consequently, Appellants argue, a person of ordinary
skill would see no reason to combine the teachings of Ohkouchi with the
4 Brochure submitted to the record by Appellants prior to the Pre-Brief
Conference (August 1, 2012).
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additional step of Sugimoto of treating the tablets with the alcohol-based
solvent. Id. at 8-9 (quoting Ohkouchi col. 2, 11. 9-20).
The Examiner finds Ohkouchi teaches a process for making an orally
disintegrating tablet, in which the tablet contains two distinct types of
particles. Final Act. 3. The Examiner finds the first particle (G), contains
the active ingredient, crospovidone, lactose, com starch, and HPC (a
water/alcohol soluble binder). Id. (citing Example 8, col. 13, 11. 5-36). The
Examiner finds the second, particles (H), contains D-mannitol and
crospovidone. Id. The Examiner finds Ohkouchi teaches the granules are
sized to 1.0 mm, mixed with crystalline cellulose, aspartame (a sweetener),
and magnesium stearate (a lubricant) and then tableted. Id.
The Examiner finds Ohkouchi also teaches the active ingredient of granule
G may be the antihistamine diphenhydramine and that the cellulose
compounds may include crystalline cellulose and hydroxypropyl cellulose.
Final Act. 3 (citing Ohkouchi col. 5, 11. 30-32; col. 3, 11. 2-5). The
Examiner further finds Ohkouchi teaches that, in a two-particle system, the
cellulose compound may be included in the particle which does not contain
the active ingredient. Id. (citing, e.g., Example 4, col. 12, 11. 5-27).
The Examiner next finds Sugimoto teaches a process for preparing an
intraorally rapidly disintegrating tablet, which has hardness of 20 N or more,
porosity within the range of 25% to 50% and improved taste at the time of
ingestion. Final Act. 4 (citing Sugimoto claim 17). The Examiner finds
Sugimoto teaches treating compressed tablets with ethanol to enhance the
hardness of the tablet. Id. (citing Sugimoto iJ 24). The Examiner finds
Sugimoto teaches that, for the alcohol-solvent treatment to enhance the
hardness of a tablet, a water- and/or alcohol-soluble binding agent must be
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present; examples of such binding agents include polyvinyl pyrrolidone
(PVP) and hydroxypropyl cellulose (HPC). Id. (citing Sugimoto iJ 27).
The Examiner concludes it would have been obvious to one of
ordinary skill in the art to modify the method of making the tablets taught by
Ohkouchi by adding the step of treating the tablets with ethanol because
Sugimoto teaches the latter step enhances the hardness of the tablets. Final
Act. 5. The Examiner finds a person of ordinary skill would reasonably
expect the hardening treatment taught by Sugimoto to work on the tablet
taught by Ohkouchi because Sugimoto teaches the treatment works when a
water- and alcohol-soluble binding agent is present and Ohkouchi teaches
use of hydroxypropyl cellulose, a water- and alcohol-soluble binder. Id.
The Examiner also concludes it would have been obvious to a skilled
artisan to substitute the specific active ingredient used in Example 8 of
Ohkouchi for another suitable active ingredient also taught by Ohkouchi,
viz., diphenhydramine, which, the Examiner finds, is both bitter-tasting and
an antihistamine, i.e., an anti-allergy drug. Final Act. 5.
Finally, the Examiner concludes, it would have been obvious to use
the flavoring agent menthol or a sweetener, as taught by Ohkouchi in an
amount which would provide optimal taste. Final Act. 6.
We agree with the Examiner's findings and conclusions and we
explicitly adopt them here as our own.
First, Appellants allege the Examiner improperly used hindsight
analysis in making findings and conclusions. See App. Br. 6. However, any
analysis of obviousness is necessarily a reconstruction based upon hindsight
reasoning, "but so long as it takes into account only knowledge which was
within the level of ordinary skill at the time the claimed invention was made
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and does not include knowledge gleaned only from applicant's disclosure,
such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395
(C.C.P.A. 1971). Appellants adduce no evidence that the Examiner's
findings and conclusion were beyond the contemporary knowledge of one of
skill in the art or could only have been taken from Appellants' Specification.
We therefore find Appellants' allegation of improper hindsight analysis by
the Examiner is without merit.
With respect to Appellants' next argument, we are not persuaded that
it would not be obvious to a person of ordinary kill to substitute
diphenhydramine as the active ingredient in Example 8. See App. Br. 6.
Appellants suggest that, because Ohkouchi teaches a "laundry list" of
potential active ingredients, a person of ordinary skill would have no
particular reason to substitute diphenhydramine for the unnamed active
ingredient of Example 8. In the case of Ohkouchi, the reference is itself
suggesting diphenhydramine as an active ingredient suitable for
incorporation into its taught methods. See Ohkouchi col. 4, 11. 21-50. We
agree with the Examiner that a person of ordinary skill, on reading the
teachings of Ohkouchi, would realize that Ohkouchi explicitly suggests
diphenhydramine as an active ingredient in its methods.
Nor are we persuaded by Appellants that, because Ohkouchi teaches a
two granule-based tablet in only some of the working examples, such a
tablet would not be obvious to the skilled artisan. See App. Br. 6. In
conducting an obviousness analysis, "' ... all disclosures of the prior art,
including unpreferred embodiments, must be considered."' Merck & Co.,
Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re
Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)). In this instance, a two
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granule-based tablet is explicitly taught and claimed by Ohkouchi. See
Ohkouchi Ex. 8, claims 1--4, 14. We agree with the Examiner that these
embodiments would be obvious to a person of skill in the art upon reading
the teachings of Ohkouchi.
We find Appellants' argument that Example 8 of Ohkouchi teaches L-
HPC instead of HPC is without merit. See App. Br. 7-8. Ohkouchi teaches
L-HPC as one species of the larger genus of cellulose compounds. See
Ohkouchi col. 2, 11. 41--44; col. 3, 11. 1-5. However, Ohkouchi is quite
precise in using the term "low-substituted hydroxypropyl cellulose" where
that is what it means, and it nowhere explicitly suggests that the
"hydroxypropyl cellulose" of Example 8 is in fact "low-substituted
hydroxypropyl cellulose." See Ohkouchi col. 8, 11. 7-26; see also col. 13, 11.
10-15.
Similarly, we are not persuaded by Appellants' contention that the
crystalline cellulose used in the Ohkouchi's exemplary embodiments should
be the same cellulose compound described in claim 1 of Ohkouchi. See
App. Br. 8. Claim 1 of Ohkouchi recites:
1. A quickly disintegrating solid preparation comprising a)
an active ingredient, b-1) a saccharide or sugar alcohol with a
mean particle diameter of 5 µm to below 90 µm, b-2) a saccharide
or sugar alcohol with a mean particle diameter of 90 µm to 500
µm, c) a disintegrating agent, and d) a cellulose compound.
(Emphasis added). "In examining the specification for proper context" it is
improper to "import limitations from the specification into the claims."
CollegeNet, Inc. v. Apply Yourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir.
2005). Ohkouchi neither teaches nor suggests that the claim term a
"cellulose compound" should be defined strictly as crystalline cellulose. On
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the contrary, Ohkouchi defines a "cellulose compound" broadly, including,
but not limited to, "one or more substances selected from the group
consisting of crystalline cellulose, powder cellulose, low substituted
hydroxypropylcellulose, and carmellose." Ohkouchi col. 3, 11. 2-5.
Finally, we are not persuaded by Appellants' assertion that Ohkouchi
teaches "an excellent invention [that] has been completed" and is therefore
somehow not susceptible of further improvement and may rest upon its
laurels. See App. Br. 9. That is not the test of obviousness, rather, the
correct "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 (C.C.P.A. 1981); see also In re Peterson, 315 F.3d 1325, 1329 (Fed.
Cir. 2003 (noting that it is "[t]he normal desire of scientists or artisans to
improve upon what is already generally known."). In the appeal before us,
the Examiner has concluded that a person of ordinary skill would have been
motivated to combine the teachings of Ohkouchi with those of Sugimoto
because Sugimoto teaches treating the tablets with ethanol enhances the
hardness of the tablets. See Final Act. 5. We agree. Consequently, we
affirm the rejections of claims 7-16, and 25. Furthermore, Appellants make
no separate argument for the separately-rejected claim 10, and so we affirm
the Examiner's rejection of that claim for the same reasons related above.
B. Claim 8 under 35 U.S.C. § 103(a)
Issue
Appellants argue claim 8 separately. App. Br. 9-10. Claim 8 recites:
"The method according to claim 7, comprising further formulating ( c) a cool
flavoring ingredient and a sweetener to one or both of (a) and (b) in (1), and
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mixing a lubricant as a component in addition to (a) and (b) in (l)." Id. at
App'x A 3. Appellants argue the Examiner erred in finding the combined
cited prior art teaches or suggests "a cool flavoring ingredient."
The Examiner finds Ohkouchi teaches that menthol may be added as a
flavoring agent. Final Act. 3 (citing Ohkouchi col. 8, 11. 53-54).
We agree with the Examiner. Appellants' Specification discloses,
with respect to a "cool flavoring ingredient": "A cool flavoring ingredient
refers to a component giving a cool feeling in an oral cavity with a small
amount, and it includes natural and artificial components. For example, one
or two or more kinds selected from menthol, ... , and it is preferable that
menthol, mentha oil and the like are used." Spec. 16, 11. 1-9. The
Specification thus discloses menthol as an example of a preferred cool
flavoring agent.
Ohkouchi explicitly teaches the addition of excipients including:
"Flavoring agents include lemon oil, orange oil, menthol, and the like."
Ohkouchi col. 8, 11. 53-54 (emphasis added). We agree that a person of
ordinary skill in the art would realize that menthol is a cooling agent and that
Ohkouchi thus teaches the limitation of claim 8.
C. Claims 23 and 24 under 35 U.S.C. § 103(a)
Issue
Appellants argue these claims together. App. Br. 10-11. Independent
claim 23 is representative and recites:
23. A method of producing a rapidly disintegrating
tablet in an oral cavity, in which tablet a bitter taste of a drug is
suppressed, comprising the following steps:
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(1) a step of mixing (a) a granule which contains
bepotastine besilate and an excipient and in which a bitter taste
has not been suppressed, (b) a granule containing a water soluble
saccharide which is insoluble in an alcohol based solvent and a
binder which is soluble in water and in an alcohol based solvent
and ( c) a cool flavoring ingredient, a sweetener and a lubricant,
(2) a step of compression-molding the mixture of (1)
and
(3) a step of treating the compression-molded product
of (2) with the alcohol based solvent.
Id. at App'x A 6. Appellants repeat their arguments supra with respect to
claim 7, and argue further that the Examiner erred in finding the combined
references teach or suggest the limitation of claim 23 reciting "a cool
flavoring ingredient." Id. at 11.
Analysis
We have related our reasons supra for concluding that claim 7 is
obvious and we incorporate them here by reference. Furthermore, and as we
have related with respect to claim 10 supra, Ohkouchi explicitly teaches the
addition of excipients including: "Flavoring agents include lemon oil, orange
oil, menthol, and the like." Ohkouchi col. 8, 11. 53-54 (emphasis added).
We consequently agree with the Examiner that a person of ordinary skill in
the art would realize that menthol is a cooling ingredient and that Ohkouchi
thus teaches the limitation of claims 23 and 24.
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D. Claims 7-16 and 23-25 under the Nonstatutory Doctrine ofObviousness-
Type Double Patenting
Issue
Appellants argue the Examiner erred in rejecting as unpatentable
claims 7-9, 11-13, 15, 16, and 25 on the ground ofnonstatutory
obviousness-type double patenting over claims 17-20 of the '208 application
and Ohkouchi. App. Br. 11. Appellants also argue claim 10 was
erroneously rejected on the same ground over the combination of the '208
application and Onuki. Id. Finally, Appellants argue that claims 14, 23, and
24 were erroneously rejected on the same ground over the combination of
the '208 application, Ohkouchi, and Onuki. Id. at 11.
Analysis
Appellants argue that claim 17 of the '208 application5 recites, inter
alia, the limitation: "wherein at least one of the ingredients (i) and (ii) is
coated with a water-soluble coating agent being insoluble in alcoholic
solvent .... " App. Br. 11. According to Appellants, the '208 application
further discloses: "a medicinal substance (i) which is hardly water-soluble
under neutral or alkaline conditions and is highly water-soluble under an
acidic conditions yet presents unpleasant taste under acidic conditions, is
characterized in that it comprises a water-soluble acidic substance" and
which "(ii) is coated with a water-soluble coating agent being insoluble in
5 Claim 7 of the issued US 7,927,623 B2. To avoid potential confusion, we
refer to it as the '"208 application" throughout.
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alcoholic solvent." Id. at 11-12 (quoting US 7,927,623 B2 (col. 3, 11. 22-
39)).
In contrast, argue Appellants, claims 7 and 22 of their application on
appeal require that the bitter taste of a drug has not been suppressed in
precursor granule (a), but the bitter taste of the drug is suppressed in the
tablet produced by the claimed method. App. Br. 12. Therefore, Appellants
contend, the claimed method of the application on appeal is different from
the method of claim 17 of the '208 application, even in view of the
secondary references. Id.
The Examiner responds that the '208 application teaches coating at
least one of ingredients (i) or (ii) with a water soluble coating agent being
insoluble in alcoholic solvent, but it does not teach this coating would taste
mask the active ingredient. Ans. 16. Further, the Examiner finds that, given
that the coating is water-soluble, even if ingredient (i) (i.e., the medicinal
component) were selected for coating, one of skill in the art would recognize
that the water soluble coating would dissolve in the oral cavity thus
permitting the taste of the active to be perceived by the user. Id.
The Examiner finds the wording of claims 7 and 23 of the present
application requires granule (a) not mask the taste of the active ingredient at
the time the substances are mixed. Ans. 16. However, the Examiner finds,
in the '208 application, it is not until the step of treating the tablets obtained
with an alcohol that the taste-masking occurs. Id. Therefore, concludes the
Examiner, the instant claims are properly rendered obvious by Sugimoto
'208 and the remaining references. Id.
"As a general rule, obviousness-type double patenting determinations
tum on a comparison between a patentee's earlier and later claims, with the
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earlier patent's written description considered only to the extent necessary to
construe its claims." Eli Lilly and Co. v. Teva Parenteral Medicines, Inc.,
689 F.3d 1368, 1378-79 (Fed. Cir. 2012). "This is so because the nonclaim
portion of the earlier patent ordinarily does not qualify as prior art against
the patentee and because obviousness-type double patenting is concerned
with the improper extension of exclusive rights-rights conferred and
defined by the claims." Id. at 1379 (emphasis in original).
Claim 17 of the '208 application requires, in relevant part: "at least
one of the ingredients (i) and (ii) is coated with a water-soluble coating agent
being insoluble in alcoholic solvent." The claim further requires "subjecting
the mixture obtained in the step ... above to compression under a low
compressing pressure" and "treating the tablets obtained in the compression
... with an alcohol followed by drying." Ingredient (i) of claim 17 is
selected from a group of medicinal agents6 and ingredient (ii) is "a water-
soluble acidic substance selected from the group consisting of fumaric acid,
tartaric acid, succinic acid, malic acid, ascorbic acid and aspartic acid."
Claim 17 also recites ingredients (iii) "a water-soluble binding agent being
soluble in alcoholic solvent selected from the group consisting of
polyvinylpyrrolidone and hydroxypropylcellulose" and (iv) "a water-soluble
saccharide selected from the group consisting of mannitol, xylitol, erythritol,
6 The group consists of: (1) (S)-2-(2-hydroxymethy 1-1-pyrrolidinyl)-4-(3 -
chloro-4-methoxybenzylamino )-5-[N-(2-pyrimidinyl methyl)carbamoyl]
pyrimidine; (2) 2-(5,6,7,8-tetrahydroimidazo[l,2-a]pyrazin-7-yl)-4-(3-
chloro-4-methoxybenzy lamino )-5-[N-(2-pyrimidiny lmethy 1) carbamoy 1]
pyrimidine; (3) 2-(5,6,7 ,8-tetrahydro-l, 7-naphthyridin-7-yl)-4-(3-
chloro-4-methoxybenzylamino )-5 [N -(2-morpholinoethyl) carbamoyl]-
pyrimidine; and ( 4) (S)-2-(2-hydroxymethyl-l-pyrrolidinyl)-4-(3-chloro-4-
methoxybenzylamino )-5-[N-( 5-pyrimidinylmethy 1) carbamoyl ]-pyrimidine.
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maltitol, sorbitol and lactose." The Specification of the '208 application
discloses that it is known in the art that the "the medicinal substances to
which the present invention is applicable are those which present unpleasant
taste such as bitterness, astringency, acridness, etc. under acidic conditions."
US 7,927,623 B2 col. 4, 11. 46-53. We rely on this disclosure to enable us to
construe the limitation of claim 17 as to whether each of the medicinal
agents recited in the claim is a bitter-tasting drug, as recited in claim 7 of
Appellants' present application.
Claim 7 of Appellants' present application recites, in relevant part: a
"step of mixing [granules] (a) ... and (b) .... " Claim 7 then requires "a step
of compression-molding the mixture" of (a) and (b ), and a step of "treating
the compression-molded product ... with an alcohol based solvent."
Granule (a) is defined as "a granule which contains a drug having a bitter
taste and an excipient and in which the bitter taste has not been suppressed."
Granule (b) is defined in the claim as "a granule containing a water soluble
saccharide which is insoluble in an alcohol based solvent and a binder which
is soluble in water and in an alcohol based solvent."
Consequently both claim 17 of the '208 application and claim 7 of the
instant application claim a process in which (1) a medicinal substance that is
bitter-tasting (ingredient (i) of the '208 application and granule (a) of the
instant application); (2) an excipient which does not mask the bitter taste
(granule (a)); (3) a water-soluble saccharide which is insoluble in an alcohol
(granule (b) and the coating of (i) or (ii)); ( 4) a binder which is soluble in
water and in an alcohol based solvent (granule (b) and ingredient (iii)); (5)
mixing the granules/ingredients supra; (5) compressing the mixture into
tablets under low compression pressure; and ( 6) treating the resultant tablets
17
Appeal 2013-011057
Application 11/989,030
with "an alcohol followed by drying" ('208 application) or "an alcohol based
solvent" (instant application).
It is thus evident that the '208 application teaches or suggests each
element of the instant application with the exception of the portion of
granule (a) that is "an excipient which does not mask the bitter taste"
although the water water-soluble saccharide of ingredient (iv) suggests such
an excipient, and such excipients were certainly well-known in the art at the
time of invention. See, e.g., Ohkouchi col. 8, 11. 31--40. We are not
persuaded by Appellants' arguments that seek to expand the definition of
ingredients (i) and (ii) beyond the scope of the claims as recited in claim 17
because, as we have stated supra, referral to the Specification of the '208
application beyond that which is necessary to construe the claim is
impermissible. Eli Lilly, 689 F.3d at 1378-79. We consequently affirm the
Examiner's provisional rejection of claims 7-16 and 23-25. Moreover,
because the '208 application has since issued as US 7,927,623 B2, the
rejection is made permanent.
CONCLUSION
We explicitly adopt the Examiner's findings and prima facie
conclusion that claims 7-16 and 23-25 are unpatentable as being obvious
under 35 U.S.C. § 103(a) and under the nonstatutory doctrine of
obviousness-type double patenting. We consequently affirm the rejections
of claims 7-16, and 23-25.
18
Appeal 2013-011057
Application 11/989,030
DECISION
The Examiner's rejection of claims 7-16 and 23-25 as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
The Examiner's rejection of claims 7-16 and 23-25 as unpatentable
under the doctrine of obviousness-type double patenting is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a)(l). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
19