Ghosh, Indrajit et al.

Patent Trials and Appeals Board

Jan 24, 2020

15934595 - (D) (P.T.A.B. Jan. 24, 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.
15/934,595 03/23/2018 Indrajit Ghosh 298046-22 2799
152174 7590 01/24/2020
ECKERT SEAMANS CHERIN & MELLOTT LLC
ATTN: Franziska Forbriger-Kramer
Two Liberty Place
50 South 16th Street, 22nd Floor
Philadelphia, PA 19102
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
01/24/2020 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):
ip2mail@eckertseamans.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte INDRAJIT GHOSH and JIA-AI ZHANG
____________

Appeal 2019-005051
Application 15/934,595
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals2 from Examiner’s
decision to reject claims 37, 38, and 47–54. 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. Appellant identifies the real party in interest as “Novartis
AG” (Appellant’s January 23, 2019 Appeal Brief (Appeal Br.) 4).
2 This Appeal is related to Appeal 2018-009026 (Application 15/017,084)
(see Appeal Br. 5). A Decision in Appeal 2018-009026 affirming
indefiniteness, obviousness, and obviousness-type double patenting
rejections was entered July 25, 2019.
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STATEMENT OF THE CASE
Appellant’s disclosure “describes formulated compositions and the
corresponding technology of manufacturing tablets for ExjadeTM
(deferasirox) to prevent gastrointestinal irritation, having no food effect and
improve patient compliance” (Spec.3 2). Appellant’s claims 37, 47, 48, and
51 are reproduced below:
37. A method of treatment of chronic iron overload in a
patient, comprising directly orally administering 90 mg
deferasirox or a pharmaceutically acceptable salt thereof in a
solid swallowable dosage form, wherein the dosage form is a
whole and intact tablet, wherein the tablet exhibits a reduced
deferasirox dissolution rate and an equivalent AUC in the
patient compared to administration of a dispersible tablet
containing 125 mg deferasirox approved by Food and Drug
Administration as Product Number 001 of New Drug
Application 021882.
(Appeal Br. 48 (emphasis added).)
47. A method of treatment of chronic iron overload in a
patient, comprising directly orally administering an amount of
deferasirox selected from the group consisting of 90, 180, and
360 mg in a solid swallowable dosage form, wherein the solid
swallowable dosage form is a whole and intact tablet, and
wherein the tablet comprises
(i) at least one filler selected from the group consisting of
microcrystalline cellulose, and ethylcellulose in a total amount
of 10% to 40% by weight based on total weight of the tablet,
(ii) at least one disintegrant selected from the group
consisting of cross-linked polyvinylpyrrolidone, starch, CMC-
Ca, CMC-Na, microcrystalline cellulose, alginic acid, sodium
alginate, and guar gum in a total amount of 1 % to 10% by
weight based on the total weight of the tablet; and,

3 Appellant’s March 23, 2018 Specification.
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(iii) at least one binder selected from the group consisting
of polyvinylpyrrolidone, hydroxypropylmethyl cellulose,
hydroxypropyl cellulose, hydroxyethyl cellulose,
microcrystalline cellulose, hypromellose, and starch in a total
amount of 1% to 5% by weight based on the total weight of the
tablet,
wherein the tablet exhibits an equivalent AUC in the
patient compared to administration of a dispersible tablet
containing 125, 250, and 500 mg deferasirox, respectively,
wherein each of the dispersible tablet containing 125, 250, and
500 mg deferasirox is approved by Food and Drug
Administration as correspondingly Product Numbers 001, 002
and 003 of New Drug Application 021882.
(Id. at 48–49 (emphasis added).)
48. A method according to claim 47 wherein the tablet comprises about 1-
55% microcrystalline cellulose.
(Id. at 49.)
51. A method of treatment of chronic iron overload in a
patient, comprising directly orally administering an amount of
deferasirox selected from the group consisting of 90, 180, and
360 mg in a solid swallowable dosage form, wherein the solid
swallowable dosage form is a whole and intact tablet, and
wherein the tablet comprises at least one binder selected from
the group consisting of polyvinylpyrrolidone,
hydroxypropylmethyl cellulose, hydroxypropyl cellulose,
hydroxyethyl cellulose, microcrystalline cellulose, and starch in
a total amount of 1% to 5% by weight based on the total weight
of the tablet, wherein the tablet exhibits a disintegration time of
5-10 minutes when measured by a standard USP disintegration
test, and wherein the tablet exhibits an equivalent AUC and a
similar therapeutic effect in the patient compared to
administration of a dispersible tablet containing 125, 250, and
500 mg deferasirox, respectively, wherein each of the
dispersible tablet containing 125, 250, and 500 mg deferasirox
is approved by Food and Drug Administration as
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correspondingly Product Numbers 001, 002 and 003 of New
Drug Application 021882.
(Id. at 49 (emphasis added).)

Grounds of rejection before this Panel for review:4
Claims 37, 38, and 47–54 stand rejected under 35 U.S.C. § 112,
second paragraph.
Claims 37, 38, and 47–54 stand rejected under the written description
provision of 35 U.S.C. § 112, first paragraph.
Claims 37, 38, and 47–54 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Zadok.5

DEFINITENESS:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that Appellant’s claims are indefinite?
ANALYSIS
Examiner finds that “[t]he FDA document referred to [in Appellant’s
claims, specifically New Drug Application (“NDA”) 021882,] does not

4 Appellant acknowledges that “[c]laims 37, 38 and 47-52 stand rejected on
the ground of nonstatutory double patenting as being unpatentable over
claims of U.S. Patent No. 9,283,209, of copending Application Nos.
15/017,084, 15/263[,]531, and 15/625,863” and asserts that “[t]hese
obviousness-type double patenting rejections are not on appeal” (Appeal Br.
11). Appellant, instead, asserts that “[u]pon an indication of the allowable
subject matter, a terminal disclaimer will be filed” (id.). Therefore, these
rejections are not included in our deliberations.
5 Zadok et al., US 2009/0142395 A1, published June 4, 2009.
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appear to be of record in the instant Application” (Final Act.6 3). Examiner
further finds that, upon “search of the FDA website,” the FDA product
claimed is based on the trademark Exjade®” (id. (emphasis omitted)). Thus,
Examiner concludes that Appellant’s claims are indefinite for failing to
identify or describe the claimed product (see id. at 3–4). We find no error in
Examiner’s conclusion.
“If the trademark or trade name is used in a claim as a limitation to
identify or describe a particular material or product, the claim does not
comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.
112, second paragraph.” MPEP § 2173.05(u). Therefore, we are not
persuaded by Appellant’s contentions relating to subject matter based on the
use of a trademark in the claims (see Appeal Br. 19).
We recognize Appellant’s contention that “the NDA claim language
was an amendment in an effort to replace ‘Exjade® . . .’ in order to
overcome the previous rejections” (Appeal Br. 17). In other words,
Appellant amended the claims in an effort to describe the claimed invention
without resort to the use of a trademark or trade name. The evidentiary
documents Appellant relied upon to support claim limitations relating to the
NDA, submitted with Appellant’s November 16, 2018 After-Final
Amendment, however, were not entered into this record and, therefore, are
not properly before this Panel for review (see Appeal Br. 17–18
(“Applicants made of record that New Drug Application 021882 Product
Numbers 001, 002 and 003 refer to EXJADE®”); cf. Advisory Action ¶ 9
(denying entry of the evidence submitted with Appellant’s November 16,

6 Examiner’s September 27, 2018 Final Office Action.
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2018 After-Final Amendment). Because the evidence relied upon by
Appellant is not properly before this Panel for review, we decline
Appellant’s invitation to consider this evidence (see Appeal Br. 19–21).
Thus, in sum, because the evidence necessary to identify the scope of
Appellant’s claimed invention is not properly before this Panel for review,
the scope of Appellant’s claims cannot be ascertained. See, Amgen Inc. v.
Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1217 (Fed. Cir. 1991)
(The legal standard for indefiniteness under 35 U.S.C § 112, second
paragraph, is whether a claim reasonable apprises those of skill in the art of
its scope).
CONCLUSION
The preponderance of evidence supports Examiner’s conclusion that
the Appellant’s claim 37 is indefinite. Appellant’s claims 38 and 47–54 are
not separately argued and fall with Appellant’s claim 37.

WRITTEN DESCRIPTION:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention?
ANALYSIS
Examiner finds that Appellant contends “that the instantly recited
FDA-NDA number is equivalent to the trademark Exjade®. However, no
documentation confirming such is of record. Thus, the recitation of the
FDA-NDA number constitutes new matter” (Final Act. 4). We find no error
in Examiner’s findings. Because the evidence relied upon by Appellant to
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support its contentions is not properly before this Panel, we are not
persuaded by Appellant’s contentions relating to the written description
rejection (see Appeal Br. 17–21).
CONCLUSION
The preponderance of evidence on this record supports Examiner’s
finding that Appellant’s Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 37 under the
written description provision of 35 U.S.C. § 112, first paragraph is affirmed.
Appellant’s claims 38 and 47–54 are not separately argued and fall with
Appellant’s claim 37.

OBVIOUSNESS:
ISSUE
Should this rejection be reversed, pro forma?
ANALYSIS
Because the appealed claims fail to satisfy the requirements of the
second paragraph of 35 U.S.C. § 112, we reverse, pro forma, Examiner’s
obviousness rejection. See Ex parte Miyazaki, 89 USPQ2d 1207, 1217–18
(BPAI 2008) (precedential) (prior art rejections of indefinite claims reversed
by Board “pro forma” where claim interpretation required resort to
“speculative assumptions as to the meaning of the claims”); accord, In re
Steele, 305 F.2d 859, 862 (CCPA 1962) (it is legal error to analyze claims
based on “speculation as to meaning of the terms employed and assumptions
as to the scope of such claims”).

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CONCLUSION
The rejection of claims 37, 38, and 47–54 under 35 U.S.C. § 103(a) as
unpatentable over Zadok is reversed, pro forma.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
37, 38, 47–54 112(a) Written Description 37, 38, 47–
54

37, 38, 47–54 112(b) Indefiniteness 37, 38, 47–
54

37, 38, 47–54 103 Zadok 37, 38, 47–
54
Overall
Outcome
37, 38, 47–
54

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).

AFFIRMED