Ex Parte Maruyama

Board of Patent Appeals and Interferences

Sep 27, 2005

09963738 (B.P.A.I. Sep. 27, 2005)

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for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte NAOSUKE MARUYAMA
__________

Appeal No. 2005-1746
Application No. 09/963,738
__________

ON BRIEF
__________

Before WILLIAM F. SMITH, 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 1-21. Claims 1 and 21 are representative of the subject
matter on appeal, and read as follows:
1. A dry direct tableting base material comprising low-substituted
hydroxypropyl cellulose impregnated with a sugar or a sugar alcohol wherein the
product resulting therefrom is dried, and wherein said low-substituted
hydroxypropyl cellulose has a hydroxypropyl content in the range from 5 to 16%
by weight.

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Application No. 09/963,738

21. The dry direct tableting base material as claimed in claim 1 wherein
said low-substituted hydroxypropyl cellulose is in fibrous form.

The examiner relies upon the following references:
Koyanagi et al. (Koyanagi) 3,852,421 Dec. 03,1974
Obara 6,380,381 Apr. 30, 2002
Shimizu et al. (Shimizu) WO 98/53798 Dec. 03,1998

Clams 1-20 stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Shimizu and Koyanagi. In addition, claim 21 stand
rejected under 35 U.S.C. § 103(a) as being obvious over the previous
combination as further combined with Obara. After careful review of the record
and consideration of the issues before us, we affirm.
DISCUSSION
Clams 1-20 stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Shimizu and Koyanagi. As claims 1-20 stand or fall
together, see Appeal Brief, page 3, we focus our analysis on the broadest claim,
claim 1.
The first step in deciding patentability issues under 35 U.S. C. § 103 is
determining what is being claimed. See Key Pharmaceuticals v. Hercon
Laboratories Corp., 161 F.3d 709, 714, 48 USPQ2d 1911, 1915 (Fed. Cir. 1998).
The preamble of claim 1 states that the composition is “[a] dry direct tableting
base material.” “If the claim preamble, when read in the context of the entire
claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to
give life, meaning, and vitality’ to the claim, then the claim preamble should be
construed as if in the balance of the claim.” Pitney Bowes Inc. v. Hewlett
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Application No. 09/963,738

Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999).
“Where . . . a patentee defines a structurally complete invention in the claim body
and uses the preamble only to state a purpose or intended use for the invention,
the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478, 42
USPQ2d 1550, 1553 (Fed. Cir. 1997).
In this case, the preamble merely states the intended use of the claimed
composition. The preamble’s statement that the composition is intended as “[a]
dry direct tableting base material” does not add any further limitations to those
recited in the body of the claim. “If the preamble adds no limitations to those in
the body of the claim, the preamble is not itself a claim limitation and is irrelevant
to proper construction of the claim.” IMS Technology, Inc. v. Haas Automation,
Inc., 206 F.3d 1422, 1434, 54 USPQ2d 1129, 1137 (Fed. Cir. 2000). Therefore,
we interpret claim 1 as encompassing compositions comprising low-substituted
hydroxypropyl cellulose impregnated with a sugar or a sugar alcohol wherein the
product resulting therefrom is dried, and wherein said low-substituted
hydroxypropyl cellulose has a hydroxypropyl content in the range from 5 to 16%
by weight.
Turning now to the rejection, Shimizu is cited for teaching a solid
preparation that “comprises a water-soluble sugar alcohol that may be selected
as sorbitol and erythritol” and “a low-substituted hydroxypropyl cellulose.”
Examiner’s Answer, page 4. Shimizu is also cited for teaching that a preferred
dosage form is a tablet, which the examiner asserts “embraces the ‘dry direct
tableting’” as required by claim 1. Id. The rejection states that “[t]he instant
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Application No. 09/963,738

claims differ from the Shimuzu [ ] patent by claiming that the base material is for
dry direct tableting.” Page 4.
Based on the panel’s construction of the claim, however, the fact that
Shimuzu fails to specifically teach that the base material is for dry direct tableting
is irrelevant, as Shimuzu teaches all of the components of the composition of
claim 1, i.e., a low-substituted hydroxypropyl cellulose impregnated with a sugar
or sugar alcohol, and thus would anticipate the composition of claim 1. Thus, we
need not reach the teachings of Koyanagi, and as we find no error in the
examiner’s conclusion that the subject matter of claim 1 is obvious, the rejection
is affirmed.1
Appellant argues that the instant claims require that the low-substituted
hydroxypropyl cellulose be impregnated with a sugar or sugar alcohol, where,
upon drying, the sugar or sugar alcohol exists inside the low-substituted
hydroxypropyl cellulose. See Appeal Brief, page 4. Shimuzu, according to
appellant, uses a fluidized bed granulator in Working Example 6 and others,
which appellant asserts allows the sugar or sugar alcohol to attach only to the
surface of the low-substituted hydroxypropyl cellulose. See id. Thus, appellant
contends, the product of Shimizu is structurally different from the claimed
product. See id.
Appellant’s arguments are not found to be convincing. Appellant’s
specification specifically teaches that:

1 In fact, under the construction of the claim set forth here, claim 1 may in fact be anticipated by
the Shimizu reference.
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Application No. 09/963,738

According to one preferred process for preparing this base
material for dry direct tableting obtained by impregnating low-
substituted hydroxypropyl cellulose with a sugar or a sugar alcohol
and then drying it, a wet granular material is prepared by dry-
blending low-substituted hydroxypropyl cellulose with a sugar or
sugar alcohol and then adding water to the resulting blend while
agitating it, or by adding an aqueous solution of a sugar or a sugar
alcohol to low-substituted hydroxypropyl cellulose while agitating it.
Thereafter, the resulting granular material is dried in the usual
manner, and may be pulverized and classified as required. Thus,
the desired base material for dry direct tableting comprising low-
substituted hydroxypropyl cellulose impregnated with a sugar or a
sugar alcohol can be obtained. In addition to the above-described
agitation granulation process, this base material may also be
prepared by fluidized bed granulation, spray drying and other
suitable processes.

Id. at 6-7 (emphasis added).
Shimizu teaches that
The solid preparation of the present invention can be
produced in accordance with a conventional method in the fields of
pharmaceutics. Such methods include, for instance, a method
which comprises blending, if necessary after addition of water, a
pharmaceutically active ingredient, a water-soluble sugar alcohol
and low-substituted hydroxypropylcellulose having hydroxypropyl
group contents of 7.0 to 9.9 percent by weight, and molding, if
necessary followed by drying.

Id. at 14. Moreover, in Working Example 1, a fluidized bed granulator is used, in
which granulation is carried out while spraying distilled water. See id. at 17.
Thus, the composition taught by Shimizu appears to be the same as that
of the composition of claim 1, and the burden is shifted to appellant to
demonstrate that they are different. See In re Best, 562 F.2d 1252, 1255, 195
USPQ 430, 433-34 (Fed. Cir. 1977). Arguments of counsel cannot take the
place of evidence in the record. See in re Scarbrough, 500 F.2d 560, 566, 182
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Application No. 09/963,738

USPQ 298, 302 (CCPA 1974); In re DeBlauwe, 736 F.2d 699, 705, 222 USPQ
191, 196 (Fed. Cir. 1984).
Appellant also contends that the declaration of Naosuke Maruyama
submitted under 37 CFR § 1.132 “show that the product provided by Shimuzu
has a lower flowability index as well as a longer disintegration time as compared
to the base materials provided in Examples 1 through 4 of the present
application.” Appeal Brief, page 7.
Appellant’s declaration is not deemed to be sufficient to overcome the
rejection. The declaration refers to Examples 1-4 of the specification, which all
appear to be limited to the use of a single type of low-substituted hydroxypropyl
cellulose, LH-11, and thus are not commensurate in scope with the subject
matter of claim 1, which is drawn to the use of any low-substituted hydroxypropyl
cellulose, wherein said low-substituted hydroxypropyl cellulose has a
hydroxypropyl content in the range from 5 to 16% by weight. See In re Peterson,
315 F.3d 1325, 1330, 65 USPQ2d 1379, 1383(Fed. Cir. 2003)(“the applicants’
showing of unexpected results must be commensurate in scope with the claimed
range). Finally, appellant has not explained how Comparative Example 2
represents the closest prior art, i.e., Shimizu. For example, Shimizu’s preferred
low-substituted hydroxypropyl cellulose appears to be LH-32 (hydroxypropyl
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Application No. 09/963,738

group content of 8.8% by weight), whereas Comparative Example 2 uses LH-11.
Thus, the declaration is not a comparison with the closest prior art.2
Claim 21 stands rejected under 35 U.S.C. § 103(a) as being obvious over
the previous combination as further combined with Obara. As appellant argues
only that Obara fails to supply the deficiencies of the previous rejection, see
Appeal Brief, page 9, this rejection is also affirmed for the reasons set forth
supra.
CONCLUSION
As the examiner has set forth a prima facie case of obviousness, the
rejection is affirmed.

2 Moreover, as Shimizu teaches all of the components of the composition of claim 1, and thus
would appear to anticipate the claimed composition, and evidence of unexpected results may not
be used to overcome an anticipatory reference.
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Application No. 09/963,738

No time period for taking any subsequent action in connection with this
Appeal may be extended under 37 CFR § 1.136(a).
AFFIRMED

William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

LG/dym
Appeal No. 2005-1746 Page 9
Application No. 09/963,738

Myers Biegel Sibley & Sajovec
PO Box 37428
Raleigh, NC 27627