Lee, Dong Ki.

Patent Trials and Appeals Board

Apr 26, 2021

2020005151 (P.T.A.B. Apr. 26, 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.
15/678,823 08/16/2017 Dong Ki Lee OLX-001C2/116825-5001 3298
23517 7590 04/26/2021
MORGAN, LEWIS & BOCKIUS LLP (BO)
1111 PENNSYLVANIA AVENUE, N.W.
WASHINGTON, DC 20004
EXAMINER
SHIN, DANA H
ART UNIT PAPER NUMBER
1635
NOTIFICATION DATE DELIVERY MODE
04/26/2021 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):
kcatalano@morganlewis.com
patents@morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_____________

Ex parte DONG KI LEE and CHAN II CHANG
_____________

Appeal 2020-005151
Application 15/678,823
Technology Center 1600
_____________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a small
interfering RNA molecule (siRNA molecule). The Examiner rejected the
claims as anticipated, as obvious, and for double patenting. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm but designate our affirmance
as a new ground.

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 the Dong Ki
Lee (see Appeal Br. 3).
2 We have considered the Specification of Aug. 16, 2017 (“Spec.”); Final
Office Action of Apr. 16, 2019 (“Final Act.”); Appeal Brief of Jan. 16, 2020,
(“Appeal Br.”); Examiner’s Answer of Apr. 27, 2020 (“Ans.”); and Reply
Brief of June 29, 2020 (“Reply Br.”).

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Statement of the Case
Background
“RNA interference (hereinafter abbreviated as ‘RNAi’) is a
phenomenon in which, when cells or the like are introduced with double-
stranded RNA . . . the dsRNA can induce degradation of the target gene
mRNA and suppress the expression of the target gene” (Spec. 1:14–19). “In
mammalian cells, like other organisms, there have been attempts to induce
RNAi by introducing exogenous dsRNA.” (id. at 2:3–4). The Specification
states
it was reported that siRNA molecules having a 2 nt overhang at
the 3’ end of each of the antisense and sense strands and
comprising a 19-bp duplex region were the initiator of RNAi
pathway and that either siRNA molecules having blunt ends or
siRNA molecules having a duplex region shorter than 19 bp
(base pair) showed low efficiency, even when they were tested
at high concentrations.
(id. at 2:14–18). However, “unexpected problems were found in gene
silencing mediated by RNAi molecules. Specifically, the problems are that
exogenous siRNA molecules saturate the RNAi machinery” and “in
conventional siRNA molecules, the sense strand rather than the antisense
strand can act, and thus the risk of off-target effects exists” (id. at 2:23–30).
The Claims
Claims 1–8 are on appeal. Claim 1 is representative and reads as
follows:
1. A small interfering RNA molecule (siRNA molecule)
comprising: a 19-21 nucleotide (nt) antisense strand; and a 15-
16 nt sense strand complementary to the antisense strand,
wherein the 5’ end of the antisense strand has a blunt end
and the 3’ end of the antisense strand has an overhang.
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The Rejections
A. The Examiner rejected claims 1–3 and 5–7 under 35 U.S.C. § 102(e)
as anticipated by Rana3 (Final Act. 2–6; Ans. 4–10).
B. The Examiner rejected claims 1–3 and 5–7 under 35 U.S.C. § 102(e)
as anticipated by Li4 (Final Act. 6–8; Ans. 10–13).
C. The Examiner rejected claims 1–8 under 35 U.S.C. § 102(e) as
anticipated by Usman5 (Final Act. 9–11; Ans. 13–16).
D. The Examiner rejected claims 1–8 under 35 U.S.C. § 103(a) as
obvious over Ford,6 Zamore,7 and Rana (Final Act. 12–19; Ans. 16–26).
E. The Examiner rejected claims 1–8 on the ground of nonstatutory
double patenting as being unpatentable over claims 1–15 of US 9,260,470
(Final Act. 19–20; Ans. 26–28).
F. The Examiner rejected claims 1–3 and 5–7 on the ground of
nonstatutory double patenting as being unpatentable over the issued claims
of US 10,059,949 (Final Act. 20–21; Ans. 28–29).
G. The Examiner rejected claims 1–4 on the ground of nonstatutory
double patenting as being unpatentable over claims of US Application No.
15/422,186, now US 10,358,648 (Final Act. 21; Ans. 29–31).
H. The Examiner rejected claims 1–3 and 5–7 on the ground of
provisional nonstatutory double patenting as being unpatentable over the
issued claims of US 15/422,122, now US 10,519,449 (Final Act. 21; Ans.
31–32).

3 Rana, T., US 2006/0069050 A1, published Mar. 30, 2006.
4 Li et al., US 2009/0208564 A1, published Aug. 20, 2009.
5 Usman et al., US 2008/0188430 A1, published Aug. 7, 2008.
6 Ford et al., US 2006/0142228 A1, published June 29, 2006.
7 Zamore et al., US 2006/0134787 A1, published June 22, 2006.
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A. 35 U.S.C. § 102(e) over Rana
The Examiner finds Rana “expressly disclosed 12 non-canonical
siRNA structures (see Figure 3) and when Rana’[s] teaching of ‘no dTdT’
overhang in the 3’end (see paragraph 0037) is taken into consideration, one
skilled in the art would at once envisage three additional structures
encompassed by the first enumerated non-canonical structure in Figure 3”
(Final Act. 3). The Examiner finds “the Rana reference does allow a person
of ordinary skill in the art, who is not an automaton, to at once envisage all
three ‘no dTdT’ structures encompassed by a 16-bp, RNAi-mediating, non-
canonical siRNA structure” (id. at 5).
Appellant contends that based on “Rana, there is no ‘generic formula’
and the Examiner does not point to any generic formula or ‘each of the
compounds included’ in such generic formula that would allow the claimed
subject matter to be anticipated per In re Petering[, 301 F.2d 676 (CCPA
1962)]” (Appeal Br. 7). Appellant contends that “the number of compounds
encompassed by Rana’s definition of non-canonical siRNA, while difficult
to precisely delineate, is massive, nearly 8,000 or more” (id. at 8).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s finding that Rana anticipates
the claims?
Findings of Fact
1. Rana teaches that “nucleic acids previously thought to be
ineffective in RNAi/gene silencing applications because of having non-
canonical ends, e.g., having a non-canonical length (i.e., being shorter than
21 nucleotides) or noncanonical overhang (i.e., lacking a 3’dTdT overhang)
are as effective as RNAi/gene silencing agents” (Rana ¶ 7).
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2. Rana teaches “[p]referably, the non-canonical siRNAs of the
invention include an antisense strand of about 19, 20, 21, or 22 nucleotides
in length and a shortened or truncated sense strand (e.g., a sense strand of
about 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,or21 nucleotides in length)”
(Rana ¶ 36).
3. Figure 3 of Rana is reproduced below:

“Exemplary non-canonical siRNAs are shown in FIG[]. 3[]” (Rana ¶ 37).
Rana explains that
non-canonical ends include a 5’ ends with 1, 2, 3, 4, 5, 6, 7, 8,
9, 10 or more nucleotide deletions (or truncations) and/or no
dTdT (also referred to as a 5’ non-canonical end) as well as a 3’
end with 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more nucleotide deletions
and/or no dTdT (also referred to as a 3’ non-canonical end).
(Rana ¶ 37).
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4. Figure 9 is reproduced, in part, below:

“FIG. 9 shows the effects of antisense strand siRNA deletions on RNAi
activity” (Rana ¶ 23). “Briefly, SS1-16dTdT AS4-19dTdT exhibited wild-type
levels of GFP knockdown (FIG. 9), indicating that a 16-nt dTdT siRNA is
as efficient at causing RNAi in vivo as a 19-nt dTdT siRNA” (Rana ¶ 147).
Principles of Law
“A patent is anticipated ‘if a single prior art reference discloses each
and every limitation of the claimed invention.’” In re Rambus, Inc., 753
F.3d 1253, 1256 (Fed. Cir. 2014) (citations omitted). And it is clear that
picking and choosing may be entirely proper in the making of a
103, obviousness rejection, where the applicant must be
afforded an opportunity to rebut with objective evidence any
inference of obviousness which may arise from the similarity of
the subject matter which he claims to the prior art, but it has no
place in the making of a 102, anticipation rejection.

In re Arkley, 455 F.2d 586, 587–88 (CCPA 1972).
Analysis
We agree with Appellant that Rana does not anticipate claim 1
because the ordinary artisan would not at once envisage an siRNA with a
truncated sense strand of 15 or 16 nucleotides hybridized to a blunt ended
antisense strand lacking the dTdT sequence. The Specification clearly
indicates that the term blunt ended refers to the situation where the sense and
antisense hybridize into a double stranded form and terminate in a base-pair,
with no overhanging base pairs (see, e.g., Spec. 19, Tables 7 and 8, where
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(b) in each table has a blunt end at the 5’ end of the antisense. Contrasted
with (a) with overhangs at both ends and (c) with an overhang at the 5’ end
of the antisense and a blunt end at the 3’ end of the antisense).
We recognize that Rana suggests a “noncanonical overhang (i.e.,
lacking a 3’dTdT overhang)” (FF 1), but there is no suggestion that this non-
canonical overhang is necessarily blunt ended, and figure 3 does not clearly
show any species with blunt end at the 5’ end of the antisense (FF 3). And
while figure 9 of Rana does show one such species with a blunt end at the 5’
end of the antisense strand and a 16 nucleotide sense strand, that species has
an 18 nucleotide antisense strand which does not fall within the requirement
of claim 1 for a 19–21 nucleotide antisense strand (see FF 4, top structure).
We also agree with Appellant that the citation of KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) (see Ans. 8) by the Examiner is
suggestive of obviousness, not anticipation.
For the purposes of whether they are anticipatory, lists and
genera are often treated differently under our case law . . . . This
distinction collapses when the class of compounds that falls
within the genus is so limited that a person of ordinary skill in
the art can “at once envisage each member of this limited
class.”
In re Gleave, 560 F.3d 1331, 1337–38 (Fed. Cir. 2009) (citing Eli Lilly &
Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1376 (Fed. Cir. 2006)).
The instant case is a genus, but not a list, and we are not persuaded that a
person of ordinary skill could at one envisage the claimed invention from the
disclosure of Rana.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s finding that Rana anticipates the claims.
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B. 35 U.S.C. § 102(e) over Li
Appellant contends the Lee Declaration is
sufficient to establish prior inventorship of the genus claimed,
which, as indicated by the Examiner, covers a mere 6 species.
The Examiner makes no factual finding as to why the difference
between these six species (19-21 nt antisense strand, with a 15
or 16 nt sense strand) are unpredictable given the Declaration
evidence showing a 19 nt antisense strand and a 15 nt sense
strand, together with knowledge available in the prior art.
(Appeal Br. 15).
The Examiner responds that
prior to Li’s invention date, it was not generally predicted in the
relevant art that a non-conventional, shorter, asymmetric
duplexes of 15-16 bps with a blunt end at the 5’ end of the anti
sense strand and an overhang at the 3’ end of the anti sense
strand, which were deemed “a novel design”, would be
considered as a “small interfering RNA molecule (siRNA
molecule)” as claimed in the instant case.
(Ans. 12).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s finding that the Lee
Declaration fails to antedate Li?
Findings of Fact
5. Table 4 of Li is reproduced, in part, below:

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“The aiRNAs, summarized in Table 4, contained modifications including,
but not limited to, length of the sense and anti-sense strands, degree of sense
and anti-sense overhangs” (Li ¶ 285).
6. The Lee Declaration8 states
siTLG3 in the 15+4A format showing highly potent gene
silencing activity, equivalent to the conventional 19+2 format
. . . The 15+4A construct includes a 19-mer antisense strand
and a 15-mer strand, where the 5’ end of the antisense strand
anneals with a blunt end of the 3’ end of the sense strand.
(Lee Decl. ¶ 6).
Principle of Law
“In general, where the reference or activity discloses the claimed
genus, a showing of completion of a single species within the genus is
sufficient to antedate the reference or activity under 37 CFR § 1.131(a)”
MPEP § 715.03(II). However, in “cases where predictability is in question,
on the other hand, a showing of prior completion of one or a few species
within the disclosed genus is generally not sufficient to overcome the
reference or activity” (id.).
Analysis
We find that Appellant has the better position. The genus of claim 1
is composed of six species of blunt ended siRNA molecules, a 15 nucleotide
sense strand with either a 19, a 20, or a 21 nucleotide antisense strand and a
16 nucleotide sense strand with either a 19, a 20, or a 21 nucleotide antisense
strand. In the §131 Declaration, Lee has shown a 15 nucleotide sense strand
with a 19 nucleotide antisense strand (FF 5).

8 Declaration of Dr. Dong-Ki Lee, Ph.D., dated Sept. 13, 2018.
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The Examiner finds that the reference, Li, teaches two anticipatory
species within the scope of claim 1, a 15 nucleotide sense strand and a 21
nucleotide antisense strand termed “aiRNA#2” and a 15 nucleotide sense
strand and a 19 nucleotide antisense strand termed “aiRNA#21” (see Non-
Final Act. 6 dated 4/3/2018)9.
Thus, the Lee Declaration teaches one of the six species in the genus
and one of the two species disclosed in the prior art. There Examiner has
presented no persuasive evidence that any of the other five species recited by
claim 1 would have been unpredictable. The Examiner’s reference to the
prior art only shows that the use of siRNA with the structure of claim 1 were
novel and were not disclosed in the prior art, but provides no statement that
siRNA with these structures would have been inoperable or otherwise
unpredictable. Because predictability is not reasonably in question based on
the evidence, completion of the species recited in the Lee Declaration is
sufficient to antedate Li.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s finding that the Lee Declaration fails to antedate Li.

C. 35 U.S.C. § 102(e) over Usman
The Examiner finds
that when paragraph 0054 [of Usman] is read with reasonable
interpretation in context, one of ordinary skill in the art would

9 We note that the Examiner also points to “aiRNA#25” but this is composed
of a 15 nucleotide sense strand and a 17 nucleotide antisense strand which
falls outside the small genus of claim 1 because the minimum length for an
antisense strand is 19 nucleotides in claim 1.
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readily understand that the phrase “each strand is about 19
nucleotides long” in the context of making an siNA molecule
forming “at least 15” base pairs with one blunt end refers to
asymmetric lengths of two strands. It is true that the third
sentence does state “where each strand is about 19 nucleotide
long”. However, one of ordinary skill in the art, who is not an
automaton, would readily understand that the third sentence in
Usman’s paragraph 0054 does describe a blunt-ended siNA
structure of about 15 base pairs.
(Final Act. 9).
Appellant contends the Examiner “relies on hindsight reconstruction
of Appellant’s claimed siRNA by cherry-picking unrelated portions (in some
instances selecting partial sentences!) from the reference” (Appeal Br. 11).
Appellant contends Usman does “not contemplate an siRNA molecule with
‘a 19-21 nucleotide (nt) antisense strand’ and ‘a 15-16 nt sense strand
complementary to the antisense strand, wherein the 5’ end of the antisense
strand has a blunt end and the 3’ end of the antisense strand has an
overhang,’ as required by claim 1” (id. at 12).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s finding that Usman
anticipates the claims?
Findings of Fact
7. Usman teaches an embodiment where
the siNA molecule is a double stranded nucleic acid molecule,
where each strand is about 19 nucleotide long and where the
nucleotides of each fragment of the siNA molecule are base-
paired to the complementary nucleotides of the other fragment
of the siNA molecule to form at least about 15 (e.g., 15, 16, 17,
18, or 19) base pairs, wherein one or both ends of the siNA
molecule are blunt ends.
(Usman ¶ 54).
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8. Usman teaches:
[A]n asymmetric duplex siNA molecule of the invention can
comprise an antisense region having length sufficient to
mediate RNAi in a cell or in vitro system (e.g. about 15 to
about 30, or about 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26,
27, 28, 29, or 30 nucleotides) and a sense region having about 3
to about 25 (e.g., about 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,
16, 17, 18, 19, 20, 21, 22, 23, 24, or 25) nucleotides that are
complementary to the antisense region.
(Usman ¶ 203).
Analysis
We agree with Appellant that Usman does not anticipate because the
species in claim 1 cannot be immediately envisaged from the disclosure of
Usman. Instead, obtaining these species would require selection of a 19
nucleotide antisense and blunt ends from paragraph 54 of Usman (FF 7) and
selection of a 15 and 16 nucleotide sense regions from paragraph 203 of
Usman (FF 8). Such “picking and choosing . . . has no place in the making
of a 102, anticipation rejection.” Arkley, 455 F.2d at 587–88. We also note
that the Examiner’s reference to “automaton” also implicitly refers to KSR
and obviousness, not the standard for anticipation.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s finding that Usman anticipates the claims.

D. 35 U.S.C. § 103(a) over Ford, Zamore, and Rana
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s finding that Ford, Zamore,
and Rana render the claims obvious?

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Analysis
We rely solely on Rana for this obviousness rejection. While we note
the Board may rely on less than all of the references applied by the
Examiner in an obviousness rationale without designating it as a new ground
of rejection (In re Bush, 296 F.2d 491, 496 (CCPA 1961)), because our
reasoning differs from that of the Examiner, we will designate this rejection
as a new ground of rejection.
Rana teaches, in Figure 9, an siRNA composition that is composed of
a 16 nucleotide sense strand, an 18 nucleotide antisense strand, with a blunt
end at the 3’ end of the antisense strand (FF 4). Rana’s siRNA therefore
differs from the limitations of claim 1 solely in the antisense strand being 18
nucleotides, one (1) nucleotide shorter than the minimum 19 nucleotides
required by claim 1.
Rana teaches, however, that “[p]referably, the noncanonical siRNAs
of the invention include an antisense strand of about 19, 20, 21, or 22
nucleotides in length and a shortened or truncated sense strand (e.g., a sense
strand of about 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21 nucleotides in
length)” (FF 2).
Thus, Rana expressly suggests that the noncanonical siRNAs (where
noncanonical includes siRNAs that lack only the dTdT and are therefore
blunt ended at the 3’ end (FF 3)), preferably have 19, 20, or 21 nucleotide
long antisense strands and may have 15 or 16 nucleotide sense strands (FF
2). Thus, Rana teaches overlapping ranges of siRNA lengths, with overlap
of the antisense strand almost fully overlapping the range of claim 1 and
overlap of the sense strand length (FF 2). In “cases involving overlapping
ranges, [courts] have consistently held that even a slight overlap in range
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establishes a prima facie case of obviousness.” In re Peterson, 315 F.3d
1325, 1329 (Fed. Cir. 2003). And in this obviousness context, it can be
properly noted that a “person of ordinary skill is also a person of ordinary
creativity, not an automaton.” KSR, 550 U.S. at 421.
Appellant contends that “in order to render the obviousness rejection,
the Examiner ignores the conclusion of Rana that 16+2 (16 nt bp with dTdT
overhangs on both ends) is the desired structure, and ignores the
demonstration in Ford that duplexes less than 18 substantially lose
effectiveness” (Appeal Br. 19).
We find this argument unpersuasive for two reasons. First, to the
extent that Rana teaches the 16+2 with dTdT shows 100% activity, Rana
also teaches that the 16+2 with a blunt end has 95% activity (FF 4). Thus,
Rana showed that a duplex with 18 nucleotides was effective, and Ford’s
teaching away is irrelevant because it does not discourage, discredit, or
otherwise teach away from either Rana’s 18 nucleotide antisense example or
Rana’s preference for siRNAs with 19–22 nucleotide antisense (FF 2, 4).
Second, disclosed examples and preferred embodiments do not constitute a
teaching away from a broader disclosure or non-preferred embodiments. In
re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971). Thus, even if Rana prefers
16+2 with no blunt ends, Appellant does not identify a teaching away from
an siRNA with a 19 nucleotide antisense strand, a 16 nucleotide sense
strand, and a blunt end at the 3’ end of the antisense strand, as is obvious
over Rana.
Appellant contends that as disclosed
in Figures 3, 4, 5(a), 6(b), 7, 8, 10, 18, and 20 of the present
application, the currently claimed siRNA shows potencies for
gene silencing that are comparable to, or more efficient than,
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the conventional 19+2 format, while substantially reducing the
silencing activity of the sense strand and not interfering with
endogenous miRNA activity or saturating the RNAi machinery.
(Appeal Br. 17).
We are not persuaded by Appellant’s reliance on unexpected results
for several reasons. First, Appellant does not show the results are
unexpected by a comparison to the closest prior art of Figure 9 of Rana,
which differs from the claim by a single nucleotide. See In re Baxter
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.”).
Second, while Appellant states “the Application as-filed contains
objective evidence of non-obviousness in the form of unexpected results,”
citing figures in the Specification, Appellant does not identify any statement
or recognition that the results were unexpected in the Specification. “[A]ny
superior property must be unexpected to be considered as evidence of non-
obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir.
2007). “[A]ttorney argument [is] not the kind of factual evidence that is
required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d
1465, 1470 (Fed. Cir. 1997).
Third, Appellant does not explain how the results are commensurate
in scope with the claims. Unexpected results must be “commensurate in
scope with the degree of protection sought by the claimed subject matter.”
In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
finding that Ford, Zamore, and Rana render the claims obvious.
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E. Double Patenting over US 9,260,470
Appellant contends “claim 1 recites that a 15-16 nt sense strand is
complementary to the antisense strand . . . Thus, the entire sense strand is
completely complementary to the corresponding nucleotides of the antisense
strand and the antisense strand has the overhang” (Appeal Br. 22).
Appellant contends: “Claim 1 does not recite or encompass any bulges or
mismatches in the duplex portion, while the claims of the ’470 patent do,
and the distinction is apparent” (id.).
The Examiner responds that
the examiner fails to see how the conflicting claims are
patentably distinct and why the term “complementary” recited
in the instant claims should differ from the “complementary”
recited in the ’470 patent claims. Note that both sets of
conflicting claims do recite the same limitation “sense strand
complementary to the antisense strand” as indicated with
underlining hereinabove.
(Ans. 27). The Examiner further contends “it is noted that a two-way test is
not required because there is no evidence that appellant ‘could not have filed
the claims in a single application and the Office is solely responsible for any
delays.’ (original emphasis). See MPEP §804” (id. at 26).
We agree with Appellant that the term “complementary” is reasonably
understood as distinct from “substantially complementary” as defined in the
Specification (see Spec. 9:11–16). So when instant claim 1 uses the term
“complementary” without the modifier of “substantially,” we understand
instant claim 1 to require 100% complete complementarity between the
sense and antisense strands of the siRNA.
When we apply this interpretation to the ’470 patent claims, we agree
with Appellant that claims 1, 4, and 5 of the ’470 patent neither anticipate or
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suggest the invention of instant claim 1 because claim 1 of the ’470 patent
requires the presence of a “single nucleotide bulge” at “a second eighteenth
or nineteenth position from the 5’ end region.” Therefore, the siRNA of the
’470 patent is necessarily not 100% complementary as required by the
instant claim 1. The Examiner provides no reason why the required single
nucleotide bulge in the ’470 patent, a requirement not only of claim 1, but
also dependent claims 4 and 5 of the ’470 patent would be removed to obtain
the siRNA of instant claim 1. Thus, under the one-way test, we agree with
Appellant that the instant claims are not obvious over the claims of the ’470
patent.
And if the two-way test were applicable, the Examiner provides no
reason why it would have been obvious to include a “single nucleotide
bulge” at “a second eighteenth or nineteenth position from the 5’ end
region” of the instant claim 1 to render claim 1 of the ’470 patent obvious.
For these reasons, we reverse the obviousness-type double patent
rejection over the claims of the ’470 patent.

F-H. Double Patenting over US 10,059,949, US 10,358,648, and US
10,519,449
Each of these patents includes claims to particular siRNA species,
with the ’949 patent reciting two pairs of specific siRNA sequences drawn to
the MyD88 gene, the ’648 patent reciting siRNA drawn to the F2RL1 gene
sequence, and the ’449 patent reciting a pair of specific siRNA sequences
drawn to the PDGFB gene (see Appeal Br. 23–24).
In each rejection, Appellant does not dispute that these species claims
would anticipate the genus of siRNA recited in the instant claim 1. Instead,
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Appellant asserts for each of these obviousness-type double patenting
rejections that the two-way test for distinctness should apply as per MPEP
§ 804, and that the instant claims would not render the species claims of the
’949 patent, the ’648 patent, or the ’449 patent obvious (see Appeal Br. 23–
24).
The Examiner responds, for each patent, that “there is no evidence
that the two conditions are satisfied to necessitate a two-way test” (Ans. 28).
The Examiner quotes MPEP § 804, which states: “A two-way test is to be
applied only when the applicant could not have filed the claims in a single
application and the Office is solely responsible for any delays” (id.). The
Examiner does not, however, provide any reasoning addressing whether the
instant claims render those of the ’949 patent, the ’648 patent, or the ’449
patent obvious, if the two-way test does apply.
As to the two-way test, we agree with Appellant that the first prong of
the test is met because the claims recited in the ’949 patent, the ’648 patent,
or the ’449 patent could not have been filed in the single instant
Specification. That is because the instant Specification does not provide
descriptive support for the particular species claims recited in the ’949
patent, the ’648 patent, or the ’449 patent.
However, as to the second prong regarding delays during the
pendency of the instant application, US 15/678,823 and its parent, US
12/808,772, Appellant provides no evidence that delays are solely due to the
USPTO. First, we note that US 15/678,823 was filed on Aug. 16, 2017,
after the Nov. 15, 2016 filing of the ’949 patent, the Feb. 1, 2017 filing of
the ’648 patent, and the Feb. 1, 2017 filing of the ’449 patent.
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US 15/678,823 includes delays due to Appellant including filing an
incomplete reply to the Notice to File Corrected Application Papers mailed
8/25/2017 necessitating a Notice of Incomplete Reply mailed 12/20/2017.
In addition, a Miscellaneous Communication to Applicant mailed 1/31/2018
noted: “The item(s) indicated below are also required and should be
submitted with any reply to this notice to avoid further processing delays.
. . . A properly executed inventor’s oath or declaration has not been received
for the following inventor(s): Dong Ki Lee Chan II Chang.” In response to
the Examiner’s Non-Final Rejection mailed 4/3/2018, Appellant filed a Req.
for Reconsideration on 9/26/2018, and paid an extension fee due to the delay
beyond the three months statutory response period (see Fee Worksheet
9/26/2018).
Similarly, US 12/808,772 was filed on June 17, 2010. However, the
sequence listing filed with the Application did not comply with the Sequence
Requirements and a notice to that effect was mailed 2/9/2012, with the
requirements being met by Appellant in a filing on 4/9/2012. Appellant also
submitted a new sequence listing on 2/6/2013 with a statement of identity
(see Resp. filed 2/6/2013 at 5). These delays are due to Appellant.
When the Federal Circuit addressed double patenting in In re Berg,
140 F.3d 1428, 1431–33 (Fed. Cir. 1998), the court stated that the two-way
test is a narrow exception to the general rule of the one-way test, and that the
two-way test applied when a later-filed improvement patent issues before an
earlier filed basic invention. Berg clearly requires that the “two-way
exception can only apply when the applicant could not avoid separate
filings, and even then, only if the PTO controlled the rates of prosecution to
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Application 15/678,823

20
cause the later filed species claims to issue before the claims for a genus in
an earlier application.” Berg, 140 F.3d at 1435.
Even if we agree that Appellant could not have avoided separate
filings, due to lack of descriptive support in US 12/808,772, Appellant has
provided no evidence that the USPTO controlled the rate of prosecution and
the evidence of Appellant’s filings as discussed above does not support such
a finding. We note the “two-way test is only appropriate in the unusual
circumstance where, inter alia, the United States Patent and Trademark
Office (PTO) is ‘solely responsible for the delay in causing the second-filed
application to issue prior to the first.’” Eli Lilly & Co. v. Barr Labs., Inc.,
251 F.3d 955, 968 n.7 (Fed. Cir. 2001) (quoting Berg, 140 F.3d at 1437).
Here, the evidence appears to show that Appellant at least partially
controlled the rate of prosecution.
We conclude that the Examiner properly applied the one-way test in
light of the Federal Circuit’s guidance in Berg and therefore affirm the
Examiner’s double patenting rejections.

DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed New
Ground
1–3, 5–7 102(e) Rana 1–3, 5–7
1–3, 5–7 102(e) Li 1–3, 5–7
1–8 102(e) Usman 1–8
1–8 103(a) Ford, Zamore,
Rana
1–8
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Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed New
Ground
1–8 Nonstatutory
Double Patenting
US 9,260,470
1–8
1–3, 5–7 Nonstatutory
Double Patenting
US 10,059,949
1–3, 5–7
1–4 Nonstatutory
Double Patenting
US 10,358,648
1–4
1–3, 5–7 Provisional
Nonstatutory
Double Patenting
US 10,519,449
1–3, 5–7
Overall
Outcome
1–7 1–8

We designated a new ground pursuant to 37 C.F.R. § 41.50(b).
Section 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.” Section
41.50(b) also provides:
When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision,
must exercise one of the following two options with respect to
the new ground of rejection to avoid termination of the appeal
as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. The new ground of rejection
is binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
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opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.

AFFIRMED; 37 C.F.R. § 41.50(b)