Ex Parte Maruyama et al

Patent Trials and Appeals Board

May 2, 2019

13909516 - (D) (P.T.A.B. May. 2, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/909,516 06/04/2013
826 7590 05/06/2019
ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000
FIRST NAMED INVENTOR
Naosuke Maruyama
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.
066035/434209 3259
EXAMINER
ROSENTHAL, ANDREWS
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
05/06/2019 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):
usptomail@alston.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NAOSUKE MARUYAMA and Y ASUYUKI HIRAMA,
Appeal2018-009010
Application 13/909,516
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
VALEK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134(a) involving
claims to methods of preparing a composite granule for tableting. The
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the real party in interest as Shin-Etsu Chemical Co.,
LTD. App. Br. 1. Herein we refer to the Final Office Action mailed
September 8, 2017 ("Final Act."), Appeal Brief filed June 7, 2018 ("App.
Br."), Examiner's Answer mailed July 20, 2018 ("Ans."), and Reply Brief
filed September 20, 2018 ("Reply Br.").
Appeal2018-009010
Application 13/909,516
STATEMENT OF THE CASE
Appellants' invention relates to the preparation of composite granules
to serve as "a base material for preparing orally fast disintegrating tablets."
Spec. ,r 5. According to the Specification, "an orally fast disintegrating
tablet having high tablet hardness and excellent disintegrability can be
obtained by tableting a granule" that has been made by "granulating a sugar
or sugar alcohol while using an aqueous dispersion comprising at least low-
substituted hydroxypropyl cellulose, polyvinyl alcohol, another sugar or
sugar alcohol, and water." Id. ,r 7.
Claims 1-5 are on appeal and can be found in the Claims Appendix of
the Appeal Brief. Claim 1 is the only independent claim and representative
of the claims on appeal. It reads as follows:
1. A method of preparing a composite granule for tableting,
comprising at least a step of granulating a second sugar or sugar
alcohol while spraying thereto an aqueous dispersion comprising
at least low-substituted hydroxypropyl cellulose having a degree
of hydroxypropoxy substitution of 5 to 16% by weight, polyvinyl
alcohol, a first sugar or sugar alcohol, and water, wherein the
aqueous dispersion coats a surface of the second sugar or sugar
alcohol for surface-modification of the second sugar or sugar
alcohol with the low-substituted hydroxypropyl cellulose and the
polyvinyl alcohol, and wherein the composite granule is
characterized by the absence of a drug except for the first sugar
or sugar alcohol and the second sugar or sugar alcohol.
App. Br. 13. Appellants seek review of the following obviousness
rejections:
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Application 13/909,516
I. Claims 1-5 under 35 U.S.C. § 103 as unpatentable over Ohkouchi2
and Maruyama, 3 and
II. Claims 1-5 under 35 U.S.C. § 103 as unpatentable over Nagahara4
and Maruyama.
The question for both rejections is: Does the preponderance of
evidence of record support Examiner's conclusion that the cited prior art
renders obvious the claimed methods?
Analysis
I. Obviousness Rejection over Ohkouchi and Maruyama
Examiner found that Ohkouchi teaches the preparation of tableting
granules comprising a sugar alcohol (mannitol) that is sprayed with an
aqueous solution ofhydroxypropyl cellulose (HPC). Final Act. 5. Relying
on Ohkouchi Example 1, Examiner found "the preparation may [also]
contain additives such as ... release-sustaining agents" that include
polyvinyl alcohol. Id. Examiner found that Maruyama teaches a modified
low-substituted hydroxypropyl cellulose (LHPC) that is impregnated with a
sugar or sugar alcohol. Id. at 6. Examiner determined that it would be
obvious to substitute Maruyama's LHPC for the HPC taught in Ohkouchi to
arrive at Appellants' claimed method "since both agents are identified as
being binding agents with the LHPC providing added benefits." Id. at 7.
Appellants argue that it would not be obvious "to replace the HPC in
2 Kazuhiro Ohkouchi et al., US 2006/0141128 Al, published June 29, 2006
("Ohkouchi").
3 Naosuke Maruyama, US 2002/0058714 Al, published May 16, 2002
("Maruyama").
4 Naoki Nagahara, US 2008/0138427 Al, published June 12, 2008
("N agahara").
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Application 13/909,516
Ohkouchi with the LHPC of Maruyama" because HPC is water-soluble,
whereas LHPC is not, and therefore one of skill would not view them to be
equivalent binding agents. App. Br. 5---6. In particular, Appellants urge that
Maruyama teaches its modified LHPC only as a base material and that the
sugar or sugar alcohol therein is mixed-not sprayed in an aqueous
dispersion, as recited in claim 1. App. Br. 7. Similarly for Examiner's
finding regarding Ohkouchi Example 1, Appellants point out that the
release-sustaining agent there is added after drying and not sprayed in an
aqueous dispersion, as claimed. App. Br. 5. Appellants argue that the
claimed method of producing granules by spraying these ingredients in an
aqueous dispersion provides "unexpected results" compared to granules
made by simply mixing the same ingredients together. App. Br. 10-11;
Reply 10.
On this record, we find that Appellants have the better position. The
rejection is largely based on Examiner's finding that the cited prior art
teaches granules that collectively include all of the same ingredients recited
in claim 1. Claim 1, however, requires more than that. Specifically,
Appellants' claims are directed to a method of preparing granules by
"spraying ... an aqueous dispersion" comprising LHPC, "polyvinyl alcohol,
a first sugar or sugar alcohol, and water" onto a second sugar or sugar
alcohol for "surface-modification of the second sugar or sugar alcohol."
Even assuming that one of ordinary skill in the art would find it obvious to
combine Ohkouchi and Maruyama, Examiner has not shown where those
references, either individually or in combination, teach the "spraying" (as
opposed to mixing or blending) of an "aqueous dispersion" containing the
recited ingredients. In particular, Maruyama's LHPC is described as a "base
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Application 13/909,516
material" formed by mixing LHPC with a sugar or sugar alcohol. Thus, if
anything, Maruyama suggests that the LHPC should be mixed with-not
sprayed----onto Ohkouchi' s mannitol to form a granule. Examiner has not
articulated a sufficient rationale to explain why it would be obvious to one of
ordinary skill in the art to use Maruyama's LHPC base material as part of a
sprayed-on dispersion, as claimed.
Appellants' Specification further evidences that the spraying required
by the claimed method significantly affects the tableting properties of the
resulting granules. Example 2 and Comparative Example 1 in the
Specification describe tablets consisting of the same amounts of the same
ingredients (i.e., LHPC, polyvinyl alcohol and mannitol). Spec. ,r 65 (Tables
1 and 2). Example 2 was prepared by spraying an aqueous dispersion to
form granules, as recited in claim 1. Id. ,r 49. Comparative Example 1 was
obtained by "a simple physical mixture" of the same ingredients. Id. ,r 66.
According to data in the Specification, the material prepared according to
the claimed method produced a significantly harder tablet that disintegrated
in less time than Comparative Example 1. See id. ,r,r 65 (Table 2); 66.
Examiner dismisses these results, stating that the "difference in
preparation methods would have been expected to result in some differences
in properties," but that response misses the salient point. Ans. 18.
Appellants' claims are limited to a particular preparation method. Thus, to
demonstrate a prima facie case of obviousness Examiner must show that the
cited prior art teaches, or otherwise renders obvious, the claimed preparation
method. Examiner has not done that. Moreover, we agree with Appellants
that the data in Table 2 of the Specification evidences that the claimed
method provides unexpected and improved results over simply mixing the
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Application 13/909,516
various ingredients as taught in Ohkouchi and Maruyama. Examiner fails to
provide any persuasive rebuttal to the data. For these reasons, we reverse.
II. Obviousness Rejection over Nagahara and Maruyama
Examiner found that Nagahara "teaches a process for making a tablet
from granules wherein the core may or may not contain an active agent" and
may comprise various ingredients, including a sugar or sugar alcohol,
polyvinyl alcohol, and LHPC. Final Act. 12. Examiner determined that it
would be obvious to use Maruyama's LHPC in Nagahara's process because
Maruyama teaches "a superior form thereof' that "imparts a high binding
power and good flowability to the resulting tablet." Id. at 14.
Appellants argue that Examiner erred by conflating N agahara' s
teachings regarding a core that does not contain a biologically active
substance, i.e., one "characterized by the absence of a drug," as required by
claim 1, with Nagahara's teachings regarding drug-containing granules.
App. Br. 9. Appellants further urge that Nagahara's teachings regarding an
"intermediate coating layer" are inapplicable because N agahara teaches that
such a layer is applied only when the granule contains a drug. Id.
We find that Appellants have the better position. While the
combination ofNagahara and Maruyama generally teaches all of the
ingredients in claim 1, Examiner has again failed to show where either
reference teaches the "spraying" of the claimed "aqueous dispersion" onto a
sugar or sugar alcohol core that does not contain a drug. As we explained
for the first rejection above, claim 1 is directed to a method of making
granules that requires this spraying step. Examiner does not demonstrate
that Maruyama teaches or suggests this step. And for the most part, the
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Application 13/909,516
passages Examiner cites from Nagahara are silent as to how the ingredients
are combined. See, e.g., Nagahara ,r,r 15-18, 20, 67----69, 91, and 122.
The only exception is Nagahara paragraphs 124--126, but Examiner
has not explained why it would be obvious to apply the "intermediate
coating layer" taught in those paragraphs to a granule "characterized by the
absence of a drug," as recited in claim 1. Specifically, Nagahara teaches that
"core granules containing [ a drug] ... may be further coated to provide an
intermediate coating layer" for "improving the stability of a drug" or
providing for "controlled release." Nagahara ,r 124. In other words,
Nagahara teaches that this layer is applied to a drug-containing granule for
purposes relating to the presence of that drug. Examiner has not articulated
a sufficient rationale for why it would be obvious to one of ordinary skill in
the art to apply the same layer to coat a granule that has no drug in it.
Accordingly, Examiner have not met the burden of presenting a prima facie
case of obviousness for these references. See In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992) ("[T]he examiner bears the initial burden, on review
of the prior art ... of presenting a prima facie case of unpatentability. "). For
these reasons, we reverse.
SUMMARY
We reverse the rejection of claims 1-5 under 35 U.S.C. § 103 as
unpatentable over Ohkouchi and Maruyama.
We reverse the rejection of claims 1-5 under 35 U.S.C. § 103 as
unpatentable over N agahara and Maruyama.
REVERSED
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