D&D Pharmatech Inc.

Patent Trials and Appeals Board

Oct 1, 2021

2021002136 (P.T.A.B. Oct. 1, 2021)

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.
14/645,276 03/11/2015 Kang Choon Lee THER 102 4935
23579 7590 10/01/2021
PABST PATENT GROUP LLP
1355 PEACHTREE STREET NE
SUITE 800
ATLANTA, GA 30309
EXAMINER
ALLEN, MARIANNE P
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
10/01/2021 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):
docketing@pabstpatent.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KANG CHOON LEE and HA NA EOM
____________

Appeal 2021-002136
Application 14/645,2761
Technology Center 1600
____________

Before DONALD E. ADAMS, CHRISTOPHER G. PAULRAJ, and
DAVID COTTA, Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to method of
treating rheumatoid arthritis. The Examiner rejected the claims on appeal on
the ground of non-statutory obviousness-type double patenting and under 35
U.S.C. § 112 for failure to comply with the written description requirement,
failure to comply with the enablement requirement, improper dependency,
and indefiniteness. An oral hearing was held on August 10, 2021, a

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. According to Appellant, the real party in interest is D&D
Pharmatech Inc. App. Br. 2.
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transcript from which has been entered into the record (“Tr.”). We affirm in
part.
STATEMENT OF THE CASE
The Specification discloses that tumor necrosis factor-related
apoptosis-inducing ligand (TRAIL) “is a type-II membrane protein that
binds to four membrane receptors, TRAIL-R1 (DR4), -R2 (DRS), -R3
(DcR1) and-R4 (DcR2), and one soluble receptor, OPG.” Spec. 2. Two of
these receptors, DR4 and DR5 have a “death domain,” which allows them to
“to trigger caspase-3 activation and apoptosis via recruitment of adaptor
molecules and the formation of a Death Inducing Signaling Complex (DISC)
when bound to TRAIL.” Id.
According to the Specification, “[s]tudies in mice . . . and human
samples show that TRAIL plays a role in arthritis” and that when TRAIL is
blocked, arthritis worsened. Id. Conversely, “when TRAIL production was
increased . . . , symptoms were diminished.” Id. Based on these and other
studies, “TRAIL and the DR4 and DR5 receptors have been identified in
therapeutic strategies for treatment of RA [rheumatoid arthritis].” Id. at 3.
However, clinical application is complicated by TRAIL’s “rapid
inactivation, low stability and solubility, fast renal clearance, and side-
effects that include hepatotoxicity.” Id. Studies have explored
reformulating TRAIL to improve its biological half-life and bioactivity in
animal models but there “remains a need for improved TRAIL-based
formulations for treatment of autoimmune diseases, particularly rheumatoid
arthritis.” Id. at 3–4.
Claims 1–3, 7, 11, 12, 15, 16, 21, 22, 26–28, 32, and 33 are on appeal.
Claim 1 is representative and reads as follows:
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1. A method of treating rheumatoid arthritis comprising
systemically administering a tumor necrosis factor-related
apoptosis-inducing ligand (TRAIL) conjugate to a subject with
rheumatoid arthritis by injection twice a week, once a week, once
every two weeks, or about once every 28 days, in an amount
between 1 mg/kg and 100 mg/kg effective to increase apoptosis
of pro-inflammatory immune cells and increase the quantity of
anti-inflammatory Foxp3+ regulatory T cells (Treg), wherein the
TRAIL conjugate comprises a
TRAIL polypeptide comprising amino acids 114-281 of
SEQ ID NO:1 fused to a multimerization domain that allows
trimerization, where the fusion polypeptide is conjugated to
polyethylene glycol (PEG) or a derivative of PEG, wherein the
PEG or the derivative thereof has a molecular weight between
5,000 and 60,000 Da.
App. Br. 33.
The claims stand rejected as follows:
I. Claims 1–3, 7, 11, 12, 22, 26–28, and 32 were rejected on the
ground of non-statutory obviousness-type double patenting over the
combination of claims 1 and 3–11 of U.S. Patent No. 10,046,059 (“the ’059
patent”) and Lee. 2
II. Claims 1–3, 7, 11, 12, 15, 16, 21, 22, 26–28, 32, and 33 were
rejected under 35 U.S.C. § 112 for failure to comply with the written
description requirement.
III. Claims 1–3, 7, 11, 12, 15, 16, 21, 22, 26–28, 32, and 33 were
rejected under 35 U.S.C. § 112 for failure to comply with the enablement
requirement.
IV. Claims 1–3, 7, 11, 12, 15, 16, 21, 22, 26–28, 32, and 33 were
rejected under 35 U.S.C. § 112 as indefinite for failing to particularly point

2 Lee et al., U.S. Patent Publication No. 2009/0203599, published Aug. 13
2009 (“Lee”).
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out and distinctly claim the subject matter which the inventors regard as the
invention.
V. Claim 22 was rejected under 35 U.S.C. § 112 as being of
improper dependent form for failing to further limit the subject matter of the
claim from which it depends.
REJECTION I
The Examiner rejected claims 1–3, 7, 11, 12, 22, 26–28, and 32 on the
ground of non-statutory obviousness-type double patenting over the
combination of claims 1 and 3–11 of the ’059 patent and Lee. Appellant
does not address the Examiner’s double patenting rejection and did not file a
terminal disclaimer that would obviate this rejection. We therefore
summarily affirm the rejection. See Manual of Patent Examining Procedure
§ 1205.02 (“If a ground of rejection stated by the examiner is not addressed
in the appellant's brief, that ground of rejection will be summarily sustained
by the Board.”).
REJECTION II
The Examiner rejected claims 1–3, 7, 11, 12, 15, 16, 21, 22, 26–28,
32, and 33 under 35 U.S.C. § 112 for failure to comply with the written
description requirement.
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must “clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation omitted, alteration
in original). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
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inventor had possession of the claimed subject matter as of the filing date.”
Id.
Claim 1
Claim 1 recites administering the claimed TRAIL conjugate “about
once every 28 days.” In rejecting claim 1 and the claims depending
therefrom for failure to comply with the written description requirement, the
Examiner found that “the specification does not provide any standard for
measuring the degree of ‘about.’” Ans. 6. The Examiner contends that it is
unclear whether the term “about” modifies the dose (“once”) or the time
period of the dose (“28 days”). Id. The Examiner also contends that it is
unclear how much variance the term “about” permits. Id. Thus, according
to the Examiner, “it is unknown what range around 28 days is
encompassed.” Id.
Appellant disputes that the uncertain scope of the term “about”
prevents the ordinary artisan from understanding that it was in possession of
the claimed subject matter. In particular, Appellant argues that the term
“about” would be understood as modifying “28 days” and not as modifying
“once.” Appeal Br. 14. Appellant explains that otherwise, “the phrase
would be interpreted as ‘about twice every 28 days,’ which would be
equivalent to ‘about once every two weeks,’” a limitation that is already
recited in claim 1. Id. Appellant also argues that the term “about” would
reasonably be understood to mean “approximately.” Id.
We begin by construing the claim. The Examiner contends that the
term “about” can be construed to modify either “28 days” or “once.” Ans. 6.
We disagree. As Appellant explains, if the term “about” were applied to
allow “about once” to encompass “twice,” it would render the recitation
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“once every two weeks” in claim 1 superfluous, because “once every two
weeks” is the same as “about twice every 28 days.” Appeal Br. 14. While
claims are given their broadest reasonable interpretation during prosecution,
this standard does not encompass construing claim 1 in a manner that would
create unnecessary redundancy. Cf., Texas Instruments, Inc. v. International
Trade Comm., 988 F.2d 1165, 1171 (Fed. Cir. 1993) (“[T]o construe the
claims in the manner suggested by TI would read an express limitation out
of the claims. This we will not do.”); Beachcombers, Int’l Inc. v. Wildewood
Creative Prods., Inc., 31 F.3d 1154, 1162 (Fed. Cir. 1994) (holding that a
claim construction that results in a dependent claim having the same scope
as the claim from which it depends, and thus renders the dependent claim
superfluous, is “presumptively unreasonable”).
The Examiner also contends that “the specification does not provide
any standard for measuring the degree of ‘about’” and thus it is unclear how
much variance the term “about” permits. Ans. 6, 13. We recognize that the
term “about” is an imprecise term. However, when considered in context of
what was claimed and what is disclosed in the Specification, the ordinary
artisan would have understood it to mean “approximately,” and thus to
encompass some modest variation from the 28 days recited in the claim. See
Modine Manufacturing Co. v. U.S. ITC, 75 F.3d 1545, 1554 (Fed. Cir. 1996)
(“Although it is rarely feasible to attach a precise limit to ‘about,’ the usage
can usually be understood in light of the technology embodied in the
invention.”); Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370
(Fed. Cir. 2014) (“Claim language employing terms of degree has long been
found definite where it provided enough certainty to one of skill in the art
when read in the context of the invention.”).
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Accordingly, we construe the term “about” to mean “approximately,”
and to modify only the phrase “once every 28 days.”
In view of our construction of “about,” we are not persuaded by the
Examiner’s contention that the ordinary artisan would not have understood
that the inventors were in possession of the claimed subject matter because it
is unclear how much variance the term allows and whether the term modifies
the dose (“once”) on the time period of the dose (“28 days”). Ans. 6.
The Specification discloses:
The dosage and frequency of administration can depend on the
TRAIL-conjugate that is selected. In some embodiments, the
TRAIL-conjugate is administered systemically once, twice, or
three times every 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,
16, 17, 18, 19, 20, 21, 28, or more days. Preferably the TRAIL-
conjugate need only be administered once every 3, 4, 5, 6, 7, or
more days. In the most preferred embodiments, the TRAIL
conjugate need only be administered once a week, once every
10 days, or once every two weeks.
Spec. 35. We recognize that this passage does not expressly recite the
phrase “about once every 28 days.” However, it does recite administration
once every 28 days and supports variation above 28 days by reciting “or
more” and variation below 28 days be reciting more frequent dosing. The
Examiner has not persuaded us that this description is insufficient to support
administration “about once every 28 days.” In re Alton, 76 F.3d 1168, 1175
(Fed. Cir. 1996) (“If . . . the specification contains a description of the
claimed invention, albeit not in ipsis verbis (in the identical words), then the
examiner . . ., in order to meet the burden of proof, must provide reasons
why one of ordinary skill in the art would not consider the description
sufficient.”). Accordingly, we reverse the Examiner’s rejection of claim 1
and the claims depending therefrom on the basis that the Specification does
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not support administration of the claimed TRAIL conjugate “about once
every 28 days.”
Claim 15
Claim 15 depends from claim 1 and further recites “administering to
the subject an agent which reduces the expression or circulation of a pro-
inflammatory molecule TNF-α.” In rejecting claim 15 for failure to comply
with the written description requirement, the Examiner found that “agents”
encompassed by claim 15 include “any agent of unspecified structure or type
(e.g., antibody, small molecule, siRNA, etc.) that could act on any part of the
TNF-α signaling pathway to reduce TNF-α expression or circulation.” Ans.
7. The Examiner concedes that the Specification discloses administering
etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol,
but contends that the disclosure of these species does not support the broader
genus of agents that reduce the expression or circulation of TNF-α. Id.
Appellant argues that the Specification identifies “etanercept,
infliximab, adalimumab, golimumab, and certolizumab pegol” as “TNA-α
inhibitors.” Reply Br. 10. Appellant also asserts that it has provided
evidence that the mechanisms of action for these inhibitors “include
reducing both the circulating levels of TNF-α and its expression.” Id.
According to Appellant, “this fully supports and describes agents listed as
TNF-α inhibitors in the application that reduce the expression or circulation
of a pro-inflammatory molecule TNF-α.” Id.
We find that Appellant has the better position. “Sufficient description
of a genus . . . requires the disclosure of either a representative number of
species falling within the scope of the genus or structural features common
to the members of the genus so that one of skill in the art can ‘visualize or
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recognize’ the members of the genus.” Ariad Pharms., Inc. v. Eli Lilly &
Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010). Here, the Specification identifies
“etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol”
as [e]xemplary TNF-α inhibitors.” Spec. 6. The Examiner does not provide
persuasive evidence or explanation why these species are insufficient to
represent the claimed genus. In re Alton, 76 F.3d 1168, 1175 (Fed. Cir.
1996) (“The examiner . . . ‘bears the initial burden . . . of presenting a prima
facie case of unpatentability.’ Insofar as the written description requirement
is concerned, that burden is discharged by ‘presenting evidence or reasons
why persons skilled in the art would not recognize in the disclosure a
description of the invention defined by the claims.’”) (internal citation
omitted). Accordingly, we reverse the Examiner’s rejection of claim 15 on
the basis that the Specification does not support the claimed genus of agents
that “reduce[] the expression or circulation of a pro-inflammatory molecule
TNF-α.”
REJECTION III
The Examiner rejected claims 1–3, 7, 11, 12, 15, 16, 21, 22, 26–28,
32, and 33 under 35 U.S.C. § 112 for failure to comply with the enablement
requirement.
Claim 1 recites a “method of treating rheumatoid arthritis” by
administering TRAIL conjugated to PEG “wherein the PEG . . . has a
molecular weight between 5,000 and 60,000 Da.” Claim 1 further recites
that the administration frequency for the TRAIL conjugate can range from
“twice a week” to “about once every 28 days.” In rejecting claim 1 for lack
of enablement, the Examiner found that the working examples provided in
the Specification “cannot be extrapolated to all sizes of PEG embraced by
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the claims.” Ans. 9. The Examiner pointed to the Specification’s teaching
that “[w]eekly administration of 5K-PEG-TRAIL did not have a statistically
significant therapeutic effect” as support that some TRAIL conjugates within
the scope of the claims were inoperative “when administered by at least
some of the timing intervals encompassed by claim 1.” Id. The Examiner
further found that there were “no experimental results where the TRAIL-
conjugate is administered once every two weeks or about once every 28
days” and “no experimental results where the PEG in the TRAIL-conjugate
is larger than 30,000 Da.” Id.
The Examiner bears the burden of explaining why the scope of
protection claimed is not adequately enabled by the description of the
invention provided in the specification including, “providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement.” In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
Here, the Specification discloses that “the frequency of administration
[of TRAIL conjugate] can be determined based on the structure of the
TRAIL-conjugate.” Spec. 35. According to the Specification, this is
because “in some embodiments, a large molecular weight PEG conjugate is
associated with a longer in vivo half-life.” Id. at 31. This is consistent with
the results reported in the Specification. For example, the Specification
discloses that, in trials using mice with collagen-induced arthritis (“CIA”),
300 μg of unconjugated TRAIL showed therapeutic effect when
administered every day, but not when administered every three days. Id. at
48. Unlike unconjugated TRAIL, 300 μg of 5K-PEG conjugated TRAIL
showed therapeutic effect when administered every three days. Id.
However, 300 μg of 5K-PEG-TRAIL was not effective when administered
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once a week. Id. at 48, 53. Unlike 5K-PEG conjugated trail, 30K-PEG
conjugated TRAIL was effective when administered once a week. Id. at 53.
These examples support that as the molecular weight of PEG increases, the
TRAIL conjugate can be administered less frequently while still retaining
therapeutic effect. Accordingly, we agree with Appellant that the
Specification “explains the relationship between the size of PEG conjugate
and the frequency of administration” by teaching that “a TRAIL conjugate
with a large molecular weight PEG has a longer in vivo half-life, requiring
less frequent administration.” Appeal Br. 24.
On this record, the Examiner has not provided sufficient reason to
doubt the assertions in the Specification that larger molecular weight PEG
conjugates are associated with longer in vivo half-lives and that the skilled
artisan could determine frequency of administration based on the structure of
the TRAIL-conjugate. We recognize that the claim encompasses some
inoperative embodiments. For example, the Examiner explains, “the
specification demonstrates that the 5K-PEG-TRAIL embodiments are
inoperative when administered by at least some of the timing intervals
encompassed by claim 1.” Ans. 9. However, the existence of inoperative
embodiments within the scope of the claims is not necessarily fatal. The
Federal Circuit explains that whether inoperative embodiments result in a
lack of enablement depends on whether the number of inoperative
embodiments requires the ordinary artisan to engage in undue
experimentation:
Even if some of the claimed combinations were inoperative, the
claims are not necessarily invalid. “It is not a function of the
claims to specifically exclude . . . possible inoperative
substances . . . .” Of course, if the number of inoperative
combinations becomes significant, and in effect forces one of
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ordinary skill in the art to experiment unduly in order to
practice the claimed invention, the claims might indeed be
invalid.
Atlas Powder Co. v. E.I. Dupont de Nemours & Co., 750 F.2d 1569, 1576–
77 (Fed. Cir. 1984) (internal citations omitted) (alterations in original).
Here, particularly given the disclosed relationship between the molecular
weight of the PEG and the half-life of the PEG-TRAIL conjugate, the
existence of inoperative embodiments does not persuaded that it would
require undue experimentation to practice the claimed method.
Accordingly, we reverse the Examiner’s rejection of claims 1–3, 7,
11, 12, 15, 16, 21, 22, 26–28, 32, and 33 under 35 U.S.C. § 112 for failure to
comply with the enablement requirement.
REJECTION IV
The Examiner rejected claims 1–3, 7, 11, 12, 15, 16, 21, 22, 26–28,
32, and 33 under 35 U.S.C. § 112 as indefinite for failing to particularly
point out and distinctly claim the subject matter that the inventors regard as
the invention.
Claim 1
Claim 1 recites “about once every 28 days.” In rejecting claim 1 and
the claims depending therefrom as indefinite, the Examiner found that “the
specification does not provide any standard for measuring the degree of
‘about.’” Ans. 11. The Examiner contends that it is unclear whether the
term “about” modifies the dose (“once”) on the time period of the dose (“28
days”). Id. The Examiner also contends that it is unclear how much
variance the term “about” permits. Id. We are not persuaded.
The Examiner’s positions as to why the term “about” is indefinite are
substantially identical to the positions the Examiner took in connection with
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the written description rejection. We do not find them persuasive for the
same reasons discussed in connection with the written description rejection
(Rejection II). Accordingly, we reverse the Examiner’s rejection of claims
1–3, 7, 11, 12, 15, 16, 21, 22, 26–28, 32, and 33 under 35 U.S.C. § 112 as
indefinite on the basis that the word “about” is unclear.
Claim 15
Claim 15 recites an “agent which reduces the expression or circulation
of a pro-inflammatory molecule TNF- α.” The Examiner rejected claim 15
as indefinite because, “[t]he use of the article ‘a’ implies that there are
multiple forms of TNF-α where some are pro-inflammatory and some are
not” and thus “[t]he claim is not clear as to what is intended.” Ans. 11. We
are not persuaded because the Specification supports that TNF-α was
known. See e.g, Spec. 1 (citing a 2007 article that describes TNF-α as an
“inflammatory cytokine” the production of which initiates “hyperplasia of
synovium”). The Examiner does not direct us to any evidence supporting
the existence of an alternative pro-inflammatory TNF-α beyond the one
known and described in the art. Accordingly, we reverse the Examiner’s
rejection of claim 15 as indefinite on the basis that the article “a” implies
multiple forms of TNF-α.
REJECTION V
The Examiner rejected claim 22 as being of improper dependent form
for failing to further limit the subject matter of the claim from which it
depends.
Claim 22 depends from claim 1 and further recites that “the TRAIL
polypeptide comprises a fragment of human TRAIL effective to bind to and
induce apoptotic signaling through TRAIL-R1 or TRAIL-R2.” In rejecting
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this claim for improper dependency, the Examiner found the recitation of
claim 22 “does not further limit the structure of the TRAIL polypeptide
(amino acids 114–281 of SEQ ID NO:1) as recited in claim 1.” Ans. 20.
The Examiner reasoned that both claim 1 and claim 22 recite the same
polypeptide and thus the properties recited in claim 22 would be inherent in
the polypeptide of claim 1.
Appellant does not dispute that the properties of claim 22 would be
inherent in the polypeptide of claim 1. See Tr. 13. Instead, Appellant argues
that in another Board decision, Ex parte Lui, Appeal No. 2018-008439, the
Board found that “[c]laims explicitly requiring a limitation implied in the
base claim . . . further limit the base claim.” Appeal Br. 29. We are not
persuaded.
As an initial matter, Ex parte Lui is not controlling because it has not
been published or found to be precedential. But even if we were bound by
Ex parte Lui, we would find it distinguishable from the present case. In Ex
parte Lui, the panel found that dependent claims including method steps that
were “implied, but not explicitly stated, in their base claims” further limited
the claims from which they depended. Here, the subject matter recited in
dependent claim 22 is more than “implied” in the base claim; it is inherent.
Therefore, unlike the claims in Ex parte Lui, claim 22 does not further limit
the claim from which it depends. Accordingly, we affirm the Examiner’s
rejection of claim 22 as being of improper dependent form for failing to
further limit the subject matter of the claim from which it depends.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–3, 7,
11, 12,
22, 26–
28, 32
Non-statutory
obviousness-type double
patenting
1–3, 7,
11, 12,
22, 26–
28, 32

1–3, 7,
11, 12,
15, 16,
21, 22,
26–28,
32, 33
112 Written Description

1–3, 7,
11, 12,
15, 16,
21, 22,
26–28,
32, 33
1–3, 7,
11, 12,
15, 16,
21, 22,
26–28,
32, 33
112 Enablement 1–3, 7,
11, 12,
15, 16,
21, 22,
26–28,
32, 33
1–3, 7,
11, 12,
15, 16,
21, 22,
26–28,
32, 33
112 Indefiniteness 1–3, 7,
11, 12,
15, 16,
21, 22,
26–28,
32, 33
22 112 Improper Dependency 22
Overall
Outcome
1–3, 7,
11, 12,
22, 26–
28, 32
15, 16,
21, 33

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-IN-PART