Gopi Venkatesh et al.

Patent Trials and Appeals Board

Oct 9, 2020

2020002049 (P.T.A.B. Oct. 9, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/310,632 12/02/2011 Gopi M. Venkatesh ADAR-12701US
325049-2806
7936
91543 7590 10/09/2020
Cooley LLP / Eurand
ATTN: Patent Group
1299 Pennsylvania Avenue, Suite 700
Washington, DC 20004
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
10/09/2020 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):
zIPPatentDocketingMailboxUS@cooley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GOPI M. VENKATESH, VIJAYA SWAMINATHAN,
JIN-WANG LAI, and JAMES M. CLEVENGER
Appeal 2020-002049
Application 13/310,632
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
ULRIKE W. JENKS, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–4, 6, 8, and 24 as obvious and on the grounds of
non-statutory obviousness type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as Adare
Pharmaceuticals, Inc. Appeal Br. 2.
Appeal 2020-002049
Application 13/310,632
2
STATEMENT OF THE CASE
The Specification describes pharmaceutical compositions
incorporated into an orally disintegrating tablet (ODT) that disintegrates in
the oral cavity of a mammal, without the need of water or other fluids. Spec.
1:8–10. Aged persons or children who are unwilling or individuals with
dysphagia have difficulty swallowing tablets and capsules and would benefit
from such an ODT. Id. at 2:4–6. While oral formulations such as
suspensions, syrups, and sachets are known, they often suffer from bitter
taste and unpleasant mouthfeel making compliance difficult. See id. at 2:5–6.
CLAIMED SUBJECT MATTER
The claims are directed to rapidly disintegrating microgranules.
Claim 1, reproduced below, is illustrative of the claimed subject matter:
1. Rapidly dispersing microgranules, which microgranules have
a median particle size in the range of about 100 μm to about
300 μm, comprising at least one sugar alcohol, saccharide, or a
mixture thereof, at least one super disintegrant, and at least one
multifunctional additive, wherein the at least one
multifunctional additive is pregelatinized starch, and is present
in an amount of 1-3 weight% of the microgranules, and the
microgranules are without an active ingredient.
Appeal Br. 22 (Claims App.) (emphasis added).
REJECTIONS
Examiner rejects the claims as follows:
1. Claims 1–4, 6, 8, and 24 are rejected under 35 U.S.C. 103(a) as
unpatentable over Venkatesh,2 in view of Hsu3 and Beatch.4

2 Venkatesh et al., US 2009/0092672 A1, publ. Apr. 9, 2009 (“Venkatesh”).
3 Hsu et al., US 2005/0147670 Al, publ. July 7, 2017 (“Hsu”).
4 Beatch et al., US 2008/0188547 A1, publ. Aug. 7, 2008 (“Beatch”).
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Application 13/310,632
3
2. Claims 1–4, 6, 8, and 24 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1–13 of
US 8,545,881 in view of Beatch.
3. Claims 1–4, 6, 8, and 24 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1–18 of
US 8,747,895 in view of Beatch.
4. Claims 1–4, 6, 8, and 24 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1–48 of
US 8,962,022 in view of Beatch.
5. Claims 1–4, 6, 8, and 24 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1–15 of
US 9,089,490 in view of Beatch.
6. Claims 1–4, 6, 8, and 24 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1–13, 23, and 24
of US 9,730,896 in view of Beatch.
7. Claims 1–4, 6, 8 and 24 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1–18 of
US 9,884,014 in view of Beatch.
OPINION
1. Obviousness over Venkatesh, Hsu, and Beatch
Examiner finds that Venkatesh teaches rapidly dispersing granules
containing disintegrant, sugar alcohol and/or saccharide, where the granules
are not greater than 300 µm. See Final Act.5 2–3 (citing Venkatesh ¶¶ 31,
43–45, 69, 72, 99). Examiner finds that “[t]he microgranules [of Venkatesh]
can also contain a binder such as corn starch at about 1%–2% (Klucel®

5 Final Office Action mailed January 28, 2019 (“Final Act.”).
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Application 13/310,632
4
LF).” Id. at 3 (citing Venkatesh ¶ 40). Examiner acknowledges that
“Venkatesh does not teach that the corn starch is pregelatinized” as recited
in the rejected claims. Id.
Examiner finds that Hsu teaches corn starch and pregelatinized starch
are suitable binders for use in oral disintegrating dosage forms, and that
starches and modified starches additionally have disintegration properties.
Final Act. 3 (citing Hsu ¶¶ 46, 47, 50, 55). In addition, Examiner finds that
“Beatch teaches that pregelatinized starch (i.e. Starch 1500) is known as a
glidant and a disintegrant.” Id. (citing Beatch (Table 5)).
Based on these teachings, Examiner concludes:
It would have been obvious to one of ordinary skill in the
art making the granules of Venkatesh to substitute the corn
starch of Venkatesh for the pregelatinized starch of Hsu, given
Hsu teaches that both corn starch and pregelatinized starch are
suitable starch binders for use in oral disintegrating
formulations. See MPEP 2144.06. Further, one of ordinary skill
in the art would expect better oral disintegration upon
substitution of pregelatinized starch for a non-disintegrant
binder because pregelatinized starch is also known as a
disintegrant.
Final Act. 3.
Appellant contends that Examiner failed to make a prima facie case
for the production of rapidly dispersing granules containing pregelatinized
starch and no drug. See Appeal. Br. 8–9.
“[E]xaminer bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability.” In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Upon review of the evidence in light of Examiner’s articulated
rationale, we agree with Appellant that Examiner has not made out a prima
facie case. In presenting the prima facie case, Examiner relies on substituting
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Application 13/310,632
5
equivalents known for the same purpose. See Final Act. 3 (citing MPEP
2133.06); Ans. 4. Specifically, Examiner relies on substituting the corn
starch taught in Venkatesh with the pregelatinized starch taught in Hsu. See
Ans. 4. We agree with Appellant that substitution of the corn starch in
Venkatesh for the pregelatinized of Hsu would not result in microgranules as
presently claimed.
Claim 1 recites that the pregelatonized starch is present in the
microgranules, but the microgranules are expressly required by the claim to
be “without an active ingredient.” Thus, active ingredients are excluded
from the claim. Venkatesh teaches the production of orally disintegrating
tablets containing lamotrigine. Venkatesh, Abstract. “Lamotrigine is an
anticonvulsant drug used in the treatment of epilepsy and bipolar disorder.”
Id. ¶ 5. According to the Specification, “active ingredients” is reasonably
interpreted to encompass pharmaceutical drug actives. See Spec. 10:12–20.
Therefore, Venkatesh’s lamotrigine is reasonably considered an “active
ingredient” as recited in the present claims and is thereby an excluded
ingredient from the rapidly disintegrating granules.
Venkatesh teaches the production two types of lamotrigine containing
orally disintegrating tablets: tablets containing only lamotrigine granules
(Venkatesh ¶ 7) or tablets containing lamotrigine granules in conjunction
with disintegrating granules containing no active ingredient (id. at 9).
Venkatesh teaches using film-forming binder in the lamotrigine containing
granules, and the film forming binder includes corn starch. Id. ¶ 40.
Venkatesh teaches that the lamotrigine containing granules can include other
ingredients such as modified starch. Id. ¶ 41. Additionally, Venkatesh
teaches that “[t]he lamotrigine-containing layer comprises about 90%-99%
lamotrigine, and about 1 % to about 10% binder.” Id. ¶ 50. Thus, the use of
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Application 13/310,632
6
corn starch and modified starch in Venkatesh is limited to the lamotrigine
containing granules. Based on these disclosures, we agree with Appellant
that Examiner has not sufficiently articulated a rationale to arrive at the
rapidly disintegrating granules that contain no active ingredient as claimed.
See Appeal Br. 14; Reply Br. 2. Examiner relies on substitution of corn
starch with pregelatinized starch, but such a substitution would only result in
granules that contain active ingredient. Examiner has not articulated a
rationale for removing the active ingredient from these granules. The
evidence of record, therefore, does not support Examiner’s position that the
combination of Venkatesh, Hsu, and Beatch renders the claims obvious.
Accordingly, we reverse the rejection relying on the combination of
Venkatesh, Hsu, and Beatch.
2–7. Non-statutory double patenting
Examiner rejected claims 1–4, 6, 8, and 24 on the basis of non-
statutory obviousness type double patenting over Patent Nos.: US 8,545,881,
US 8,747,895, US 8,962,022, US 9,089,490, US 9,730,896, and
US 9,884,014. See Final Act. 9; Ans. 5–8.
Appellant does not argue the merits of these non-statutory double
patenting rejections, but notes that they will consider submitting a terminal
disclaimer upon the indication of allowable subject matter. See Appeal Br.
21 (“Appellant requests that these rejections be held in abeyance until the
pending claims are otherwise allowable, at which time Appellant may file a
terminal disclaimer to obviate [these] rejection[s].”). We therefore
summarily affirm these rejections. See Manual of Patent Examining
Procedure § 1205.02 (9th Ed., Rev. 08.2017, Jan. 2018) (“If a ground of
rejection stated by the examiner is not addressed in the appellant’s brief,
appellant has waived any challenge to that ground of rejection and the Board
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Application 13/310,632
7
may summarily sustain it, unless the examiner subsequently withdrew the
rejection in the examiner’s answer.”).
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 6, 8, 24 103 Venkatesh, Hsu,
Beatch
1–4, 6, 8, 24
1–4, 6, 8, 24 Non-statutory
double patenting
over US 8,545,881
1–4, 6, 8, 24
1–4, 6, 8, 24 Non-statutory
double patenting
over US 8,747,895
1–4, 6, 8, 24
1–4, 6, 8, 24 Non-statutory
double patenting
over US 8,962,022
1–4, 6, 8, 24
1–4, 6, 8, 24 Non-statutory
double patenting
over US 9,089,490
1–4, 6, 8, 24
1–4, 6, 8, 24 Non-statutory
double patenting
over US 9,730,896
1–4, 6, 8, 24
1–4, 6, 8, 24 Non-statutory
double patenting
over US 9,884,014
1–4, 6, 8, 24
Overall
Outcome
1–4, 6, 8, 24
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED