Punit Seth et al.

Patent Trials and Appeals Board

Jul 10, 2020

14238439 - (D) (P.T.A.B. Jul. 10, 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.
14/238,439 07/07/2014 Punit P. Seth CORE0099USA 1096
130682 7590 07/10/2020
McNeill Baur PLLC/Ionis Pharmaceuticals
125 Cambridge Park Drive
Suite 301
Cambridge, MA 02140
EXAMINER
POLIAKOVA-GEORGA, EKATERINA
ART UNIT PAPER NUMBER
1635
NOTIFICATION DATE DELIVERY MODE
07/10/2020 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):
docketing@mcneillbaur.com
eofficeaction@appcoll.com
rebecca.scarr@mcneillbaur.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PUNIT P. SETH, MICHAEL OESTERGARRD,
and ERIC E. SWAYZE

Appeal 2020-000744
Application 14/238,439
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS,
and ELIZABETH A. LAVIER, Administrative Patent Judges.
LAVIER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 273 and 275–292. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The claims are directed to modified oligomeric compounds. Claim
273 is illustrative:
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273. An oligomeric compound comprising a modified oligonucleotide
having a modification motif comprising:
a 5'-region consisting of a motif selected from: AABB, AAAB,
ABAB, ABABAB, ABABBB, AAABB, AAAABB, AAAAB,
AABBB, and ABBBB;
a 3'-region consisting of a motif selected from: BBA, AAB, AAA,
BBB, BBAA, AABB, WAAB, BBBBA, BBBB, BBBBBA,
ABBBBB, BBAAA, AABBB, BBBAA, BBBBA, BBBBB,
BBAAAA, AABBBB, BAAAA, and ABBBB; and
a central region between the 5'-region and the 3'-region consisting of a
nucleoside motif selected from: DDDDDD, DDDDDDD,
DDDDDDDD, DDDDDDDDD, DDDDDDDDDD, DDDDDDDDD,
DXDDDDDDD, DDXDDDDDD, DDDXDDDDD, DDDDXDDDD,
DDDDDXDDD, DDDDDDXDD, DDDDDDDXD, DXXDDDDDD,
DDDDDDXXD, DDXXDDDDD, DDDXXDDDD, DDDDXXDDD,
DDDDDXXDD, DXDDDDDXD, DXDDDDXDD, DXDDDXDDD,
DXDDXDDDD, DXDXDDDDD, DDXDDDDXD, DDXDDDXDD,
DDXDDXDDD, DDXDXDDDD, DDDXDDDXD, DDDXDDXDD,
DDDXDXDDD, DDDDXDDXD, DDDDXDXDD, and
DDDDDXDXD, DDDDDDDD, DXDDDDDD, DDXDDDDD,
DDDXDDDD, DDDDXDDD, DDDDDXDD, DDDDDDXD,
DXDDDDXD, DXDDDXDD, DXDDXDDD, DXDXDDDD,
DXXDDDDD, DDXXDDDD, DDXDXDDD, DDXDDXDD,
DXDDDDXD, DDDXXDDD, DDDXDXDD, DDDXDDXD,
DDDDXXDD, DDDDXDXD, and DDDDDXXD, DXDDDDD,
DDXDDDD, DDDXDDD, DDDDXDD, DDDDDXD, DXDDDXD,
DXDDXDD, DXDXDDD, DXXDDDD, DDXXDDD, DDXDXDD,
DDXDDXD, DDDXXDD, DDDXDXD, and DDDDXXD,
DXDDDD, DDXDDD, DDDXDD, DDDDXD, DXXDDD,
DXDXDD, DXDDXD, DDXXDD, DDXDXD, and DDDXXD;
wherein each A is a non-bicyclic modified nucleoside, each B is a
bicyclic nucleoside, each W is a modified nucleoside, each D is an
unmodified deoxynucleoside, and each X is a modified nucleoside or
comprises a modified nucleobase; and wherein the modified
Appeal 2020-000744
Application 14/238,439
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oligonucleotide has a nucleobase sequence complementary to the
nucleobase sequence of a target region of a target nucleic acid.

Appeal Br. 21–22 (Claims Appendix).
REFERENCES
The Examiner relies on the following references:
Name Reference Date
’418 patent US 9,695,418 B2 July 4, 2017
’142 patent US 9,752,142 B2 Sept. 5, 2017
’069 application App. No. 14/435,069 Apr. 10, 2015 (filed)
’248 application App. No. 14/911,248 Feb. 9, 2016 (filed)
’037 application App. No. 15/407,037 Jan. 16, 2017 (filed)
’489 application App. No. 15/468,489 Mar. 24, 2017 (filed)
REJECTIONS
1. Claims 273 and 275–292 stand rejected on the ground of
obviousness-type double patenting as obvious over claims 1–17 of
the ’418 patent. Non-Final Action 3.2
2. Claims 273 and 275–292 stand rejected on the ground of
obviousness-type double patenting as obvious over claims 1–26 of
the ’142 patent. Non-Final Action 4.
3. Claims 273 and 275–292 stand rejected provisionally on the
ground of obviousness-type double patenting as obvious over

2 Non-Final Office Action dated October 1, 2018.
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claims 372–383, 385, 386, and 388–391 of the ’069 application.
Non-Final Action 4.
4. Claims 273 and 276–291 stand rejected provisionally on the
ground of obviousness-type double patenting as obvious over
claim 200 of the ’248 application. Non-Final Action 5.
5. Claims 273 and 275–292 stand rejected provisionally on the
ground of obviousness-type double patenting as obvious over
claims 1–22 of the ’037 application. Non-Final Action 5.
6. Claims 273 and 275–292 stand rejected provisionally on the
ground of obviousness-type double patenting as obvious over
claims 41–62 of the ’489 application. Non-Final Action 6.
OPINION
Although there are six rejections on appeal, four can be dispensed
with quickly, and the other two share a single, controlling legal issue.
A. Rejections 1, 3, 4, & 6
Rejection 1 was obviated by Appellant’s successfully-filed terminal
disclaimer, dated October 29, 2019. Accordingly, Rejection 1 is reversed.
Rejections 3, 4, and 6 are based on claims of applications that have
been abandoned. Accordingly, Rejections 3, 4, and 6 are dismissed as moot.
B. Rejections 2 & 5
This leaves Rejections 2 and 5. In sum, the reference claims (for each
rejection) are drawn to a genus that, per the disclosure of the reference
patent/application, encompass certain species recited in the rejected claims.
1. Rejection 2
With respect to Rejection 2, the Examiner finds:
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Although the claims at issue are not identical, they are not
patentably distinct from each other because instant claims
rendered obvious by ’142 claims drawn to gapped oligomeric
compounds including a variety of modifications such as bicyclic
nucleosides. Further ’142 teaches specific wing and gap motifs,
identical to instantly claimed (see Table 1 in column 37) and one
of the motifs is exemplified in Example 30 (see column 90, lines
55–61): AAABB-(D)7-BBAAA (5'-central-3' regions).
Therefore one of the ordinary skill in the art would understand
that oligomeric compounds, identical to instantly claimed, are
within the scope of compounds claimed in ’142.
Non-Final Action 4; see also Ans. 8 (“[T]he only difference between instant
claims and claims from ’142 is that the instant claims specify modifications
in the gap and the wings, while claims from ’142 essentially claim the same
gapped oligomeric compound, but without specifying the possible structures
for the gap and the wings.”).
Appellant does not appear to dispute the Examiner’s characterization
of the ’142 claims or its specification. See generally Appeal Br. 7–12; Reply
Br. 8–9. Rather, Appellant argues that the Examiner’s reliance on the ’142
specification was inappropriate to an obviousness-type double patenting
analysis, which focuses on the claims (rather than the disclosure overall) of
the reference patent:
Even if the ’142 patent specification discloses certain
compounds within the scope of the present claims . . . the
Examiner may not rely on that disclosure to “bridge the distance”
between the ’142 patent claims and the present claims. Appellant
maintains that it is improper to import limitations from the
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specification that are otherwise not present in the ’142 claims.
To do so is treating the ’142 patent disclosure as prior art . . . .
Appeal Br. 12.
2. Rejection 5
Similarly, for Rejection 5, the Examiner finds:
Although the claims at issue are not identical, they are not
patentably distinct from each other because instant claims are
anticipated and rendered obvious by ’037 claims drawn to
gapped oligomeric compounds including a variety of
modifications such as bicyclic nucleosides. Further specification
of ’037 teaches specific wing and gap motifs, identical to
instantly claimed (see paragraphs [0235, 0250, Table 1] of ’037
specification) and one of the motifs is exemplified in Example
25 (see Table in paragraph [0449], compound 05/571123, of ’037
specification): AAA BB-(D)7-BBA (5'-central-3' regions).
Therefore one of the ordinary skill in the art would understand
that oligomeric compounds, identical to instantly claimed, are
within the scope of compounds claimed in ’037.
Non-Final Action 5–6; see also Ans. 11–12.
Again, Appellant does not take issue with the Examiner’s factual
findings with respect to the ’037 claims and its specification. See generally
Appeal Br. 12–16; Reply Br. 9–10. Instead, Appellant similarly maintains
that this rejection improperly imports structural elements from the reference
specification into the claims:
Neither claim 1 nor any of the dependent claims of the ’037
application recites any particular motifs in the 5' or 3' region. The
only contention the Examiner makes in order to reach those
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specific motifs is by reference to particular compounds disclosed
in the ’037 specification.
Appeal Br. 14.
3. Analysis
The guiding principle behind the doctrine of obviousness-type double
patenting is “to prevent a patentee from obtaining a time-wise extension of
[a] patent for the same invention or an obvious modification thereof.” In re
Lonardo, 119 F.3d 960, 965 (Fed. Cir. 1997). This principle informs a two-
step analytical process: (1) claim construction, to “determine the
differences” between the claim at issue and the reference claim from a
commonly-owned patent, and (2) an assessment of “whether the differences
in subject matter between the two claims render the claims patentably
distinct.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967–72 (Fed.
Cir. 2001). Notably, “[b]ecause nonstatutory double patenting compares
earlier and later claims, an earlier patent’s disclosure is not available to show
nonstatutory double patenting.” Geneva Pharm., Inc. v. GlaxoSmithKline
PLC, 349 F.3d 1373, 1385 (Fed. Cir. 2003). But as with any other claim
construction exercise, the specification is a key source for understanding the
meaning of its claims; indeed, the disclosures of both the reference patent
and that of the claims at issue are available “to ascertain any overlap in the
claim scope for the double patenting comparison.” Id.; see also Pfizer, Inc.
v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1363 n.8 (Fed. Cir. 2008)
(explaining that, in an obviousness-type double patenting analysis, “[t]here
is nothing that prevents us from looking to the specification to determine the
proper scope of the claims”).
In Geneva, the Federal Circuit found that a later claim to a method of
using a compound was not patentably distinct from an earlier-issued claim to
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that compound, where the earlier-issued patent disclosed (but did not claim)
the utility that was the subject of the later patent’s method claim. See
Geneva, 349 F.3d at 1385–86. To be sure, that is not the fact pattern here, as
the present claims and the reference claims are all drawn to compounds. But
using the reference patent’s disclosure to inform the bounds of the reference
claims is not limited to compound-then-method situations. Geneva is
illustrative in that respect. The Federal Circuit, like the Court of Customs
and Patent Appeals before it, has consistently recognized the need (and
propriety) of turning to the reference patent’s disclosure to construe its
claims when evaluating obviousness-type double patenting:
While we stated in [In re] Kaplan, [789 F.2d 1574 (Fed. Cir.
1986),] that it is impermissible to treat a “patent disclosure as
though it were prior art” in a double patenting inquiry, we further
reaffirmed the holding in In re Vogel, 57 C.C.P.A. 920, 422 F.2d
438 (CCPA 1970), that certain instances may exist where a
patent’s disclosure may be used. Kaplan, 789 F.2d at 1580.
Indeed, our predecessor court stated that a patent’s disclosure
may be used to determine whether an application claim is merely
an obvious variation of an invention claimed in a
patent. Vogel, 422 F.2d at 441–42. The court stated that the
disclosure may be used to learn the meaning of terms and in
“interpreting the coverage of [a] claim.” Id. at 441. It may also
be used to answer the question whether claims merely define an
obvious variation of what is earlier disclosed and claimed. The
court stated that the disclosure “sets forth at least one tangible
embodiment within the claim, and it is less difficult and more
meaningful to judge whether [something] has been modified in
an obvious manner.” Id. at 442. The court further stated that
“use of the disclosure is not in contravention of the cases
forbidding its use as prior art, nor is it applying the patent as a
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reference under 35 U.S.C. § 103, since only the disclosure of the
invention claimed in the patent may be examined.” Id.
In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1378–79 (Fed. Cir.
2008); see also Sun Pharm. Indus. Ltd. v. Eli Lilly & Co., 611 F.3d 1381,
1387 (Fed. Cir. 2010).
Claim 1 of the ’142 patent and claim 1 of the ’037 application are
each drawn to “[a] gapped oligomeric compound,” which those claims
further define in different respects. And it is this term for which the
Examiner looks to the respective specifications for additional elucidation.
See Ans. 8, 10. Correctly noting that neither set of reference claims recites
gap or wing structural elements, or motifs or patterns thereof (see Reply Br.
9–10), Appellant argues the Examiner is not using the reference
specifications to define the term “gapped oligomeric compound,” but rather
to impermissibly import limitations into the reference claims, that is, to
“bridge the distance” to the appealed claims by improperly using the
reference specifications as prior art (see id.).
Although a term may be defined through its description in the
specification, it can also be defined by examples, i.e., with respect to
individual species that fall inside (or outside) the boundary of the genus
encompassed by the claim term. The Examiner’s use of the reference
specifications is an instance of this enumerative approach. To understand
the meaning of “gapped oligomeric compound” as used in the reference
claims, the Examiner consulted the examples of such gapped oligomeric
compounds in the reference specifications. Doing so, the Examiner found
species that fall within the present claims.
But as with an obviousness analysis under § 103, a claimed species is
not necessarily obvious in view of a broader claimed genus for purposes of
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obviousness-type double patenting. Accord AbbVie Inc. v. Mathilda &
Terence Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 1379
(Fed. Cir. 2014) (“To be sure, obviousness is not demonstrated merely by
showing that an earlier expiring patent dominates a later expiring
patent. . . . It is well-settled that a narrow species can be non-obvious and
patent eligible despite a patent on its genus.”). Among other non-
precedential PTAB decisions, Appellant cites Ex parte Charneau for the
premise that “[t]he fact that there is overlap between the two sets of
claims . . . is not dispositive” of obviousness-type double patenting (Reply
Br. 6 (quoting Charneau, Appeal No. 2017–007404, 2019 WL 1040999, at
*3 (PTAB Feb. 4, 2019)). Indeed not. But in Charneau, the Examiner
impermissibly used the reference specification “for how one might extend
the method invention recited in the claims” of the reference patent
(Charneau, 2019 WL 1040999, at *3). In contrast, here the Examiner turned
to the reference specifications for confirmation that a particular species is
within the genus covered by the reference claims; no extension of the
reference invention is at issue. More closely aligned with the facts before us
is thus Ex parte Van Berkel, Appeal No. 2018–008330, 2019 WL 7876464
(PTAB July 23, 2019), in which the Board affirmed an obviousness-type
double patenting rejection where the reference claim recited a genus
encompassing the narrower subject matter of the rejected claims. In Van
Berkel, the reference claim and the rejected claims were directed to a
conjugate comprising an anti-PMSA antibody, but the rejected claims
(unlike the reference claim) specified particular amino acid sequences. See
id. at *2. The Board concluded that the Examiner had correctly determined
that the rejected claims fell within the scope of the reference claim, having
consulted the reference specification to determine, by way of example, the
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meaning of the generic term “antibody” recited in the reference claims. See
id.
Here, as in Van Berkel, the Examiner looked to the reference
specification for examples of the particular species falling within the scope
of the reference claims. And unlike in Charneau, the Examiner does not use
the reference specification as a springboard from which to extend the
reference claims. We conclude that the ordinarily skilled artisan, reading the
claims of the ’142 patent or the ’037 application, would have readily
envisaged that the “gapped oligomeric compounds” so claimed would
encompass the species exemplified in their respective specifications.3
“[E]even a minimal concern for the public interest requires an
applicant to establish that the inventions are in fact independent and distinct
and hence that the grant of a patent on the later application will not result in
a timewise extension of the protection afforded by [their] earlier patent.” In
re Schneller, 397 F.2d 350, 354 (CCPA 1968). Were we to preclude the
Examiner from looking to the reference disclosure to determine whether a
newly-claimed species expressly falls within a genus claimed in the
reference patent (or application), an enterprising applicant could greatly
extend their patent protection simply by picking out each exemplified
species to claim in a separate application, one by one, like apples from a
tree. As with the harvest, patentability has its season.
Accordingly, for the reasons described herein and those already of

3 This finding is not unrebuttable. As the AbbVie court explained, “[a]
species contained in a previously patented genus may be patentable if the
species manifests unexpected properties or produces unexpected results.”
764 F.3d at 1380. But Appellant has proffered no such evidence here.

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record, we conclude that the Examiner correctly determined that claim 273
is not patentably distinct from claims 1–26 of the ’142 patent (Rejection 2)
or from claims 1–22 of the ’037 application (Rejection 5). Appellant does
not separately argue claims 275–292 from claim 273 with respect to either
rejection; these claims fall with claim 273. See 37 C.F.R. § 41.37(c)(1)(iv).
We affirm Rejections 2 and 5 in their entirety.
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CONCLUSION
Rejections 2 and 5 are affirmed, Rejection 1 is reversed, and
Rejections 3, 4, and 6 are dismissed as moot.

DECISION SUMMARY
Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed Dismissed
273, 275–
292
’418 patent claims
1–17
273,
275–292

273, 275–
292
’142 patent claims
1–26
273,
275–292

273, 275–
292
’069 application
claims 372–383,
385, 386, 388–391
273, 275–
292
273, 276–
291
’248 application
claim 200
273, 276–
291
273, 275–
292
’037 application
claims 1–22
273,
275–292

273, 275–
292
’489 application
claims 41–62
273, 275–
292
Overall
Outcome
273,
275–292

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