Court Opinion

ID: 4238481
Source: CourtListenerOpinion
Date Created: 2018-01-23 17:00:34.358004+00
Date Added: 2024-06-11T07:48:03.469133
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                 ______________________

   IN RE: JANSSEN BIOTECH, INC., NEW YORK
                  UNIVERSITY,
                    Appellants
              ______________________

                       2017-1257
                 ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. 90/012,851.
                  ______________________

               Decided: January 23, 2018
                ______________________

    WILLIAM C. ROOKLIDGE, Gibson, Dunn & Crutcher
LLP, Irvine, CA, argued for appellants. Also represented
by JEFFREY PAUL KUSHAN, Sidley Austin LLP, Washing-
ton, DC.

   FRANCES LYNCH, Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, argued for
appellee Joseph Matal. Also represented by NATHAN K.
KELLEY, KAKOLI CAPRIHAN.
                ______________________

    Before PROST, Chief Judge, REYNA and WALLACH,
                    Circuit Judges.
PROST, Chief Judge.
    Janssen Biotech, Inc., and New York University (col-
lectively, “Janssen”) appeal from a decision of the United
2                                IN RE: JANSSEN BIOTECH, INC.

States Patent and Trademark Office (“PTO”), Patent Trial
and Appeal Board (“Board”) resulting from an ex parte
reexamination of U.S. Patent No. 6,284,471 (“’471 pa-
tent”). The Board affirmed the rejection of claims 1–7 of
the ’471 patent as unpatentable under the doctrine of
obviousness-type double patenting. Because the claims
are barred under that doctrine, we affirm.
                             I
    “The doctrine of obviousness-type double patenting is
intended to prevent the extension of the term of a patent
by prohibiting the issuance of the claims of a second
patent that are not patentably distinct from the claims of
the first patent.” G.D. Searle LLC v. Lupin Pharm., Inc.,
790 F.3d 1349, 1351 (Fed. Cir. 2015) (citing Eli Lilly &
Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376
(Fed. Cir. 2012)). In this case, Janssen’s principal argu-
ment is that obviousness-type double patenting is not
applicable because the safe-harbor provision of 35 U.S.C.
§ 121 protects the ’471 patent claims. Thus, as in Searle,
the double-patenting issue in this case turns on whether
Janssen is entitled to invoke § 121 as a defense against a
double patenting rejection. That issue depends, in turn,
on an interpretation of the prosecution history of the ’471
patent and that patent’s relationship to application
No. 08/013,413 (“’413 application”).
IN RE: JANSSEN BIOTECH, INC.                             3

   Below is a diagram illustrating the relationship be-
tween the relevant applications.

See Appellee’s Br. 11.
    On October 27, 1993, an examiner issued a 5-way re-
striction requirement in the ’413 application. 1 As rele-
vant here, Group I was drawn to antibodies,
pharmaceutical compositions, and assay methods, and
Group IV was drawn to methods for treating an animal by
administering a pharmaceutical composition containing
an antibody. On February 4, 1994, rather than filing a

    1   “If two or more independent and distinct inven-
tions are claimed in a single application, the examiner in
an Office action will require the applicant in the reply to
that action to elect an invention to which the claims will
be restricted, this official action being called a require-
ment for restriction (also known as a requirement for
division).” 37 C.F.R. § 1.142(a) (emphasis added).
4                               IN RE: JANSSEN BIOTECH, INC.

response to the restriction in the ’413 application, Janssen
expressly abandoned that application and stated that it
was filing a continuation-in-part (“CIP”) application. 2
That same day, Janssen filed application No. 08/192,093
(“’093 application”) and application No. 08/192,102 (“’102
application”). The challenged patent, the ’471 patent,
issued on the ’093 application. A reference patent, U.S.
Patent No. 5,656,272 (“’272 patent”), issued on the ’102
application.
    When Janssen filed the ’093 application, it disclosed
and claimed subject matter not only from the ’413 applica-
tion, but also from application No. 08/010,406 (“’406
application”). Accordingly, Janssen designated the ’093
application as a CIP of the ’413 application and as a CIP
of the ’406 application. The ’413 application relates to
antibodies specific to human tumor necrosis factor
(“TNF”) alpha. Its original claims included claims to a
chimeric antibody and methods of treatment. All of the
chimeric antibody claims were limited to antibodies that
bind to TNF alpha. The ’406 application relates to immu-
noreceptor molecules that are specific for TNF alpha or
beta. Claim 1 recited an immunoreceptor molecule capa-
ble of binding to TNF alpha or TNF beta or both. De-
pendent claims specified that the TNF receptor comprises
at least a portion of p55 or at least a portion of p75.
Janssen allowed the ’406 application to go abandoned
about six months after it filed the ’093 application.

    2   “A continuation-in-part is an application filed dur-
ing the lifetime of an earlier application by the same
applicant, repeating some substantial portion or all of the
earlier application and adding matter not disclosed in the
said earlier case.” Manual of Patent Examining Proce-
dure (“MPEP”) § 201.08 (5th ed., Rev.15, 1993) (emphasis
added); see also MPEP § 201.08 (2015).
IN RE: JANSSEN BIOTECH, INC.                              5

     A little over ten months after the filing date, Janssen
filed a preliminary amendment in the ’093 application,
which cancelled, amended, and added claims.              The
amendment cancelled claims drawn to the non-elected
treatment-method invention (Group IV) pursuant to the
restriction requirement set forth in the ’413 application.
The amendment did not, however, limit the claimed
subject matter to only subject matter claimed and dis-
closed in the ’413 application. After the amendment, the
’093 application still included claims directed to chimeric
antibodies (based on the ’413 application) and immunore-
ceptor molecules comprising TNF receptors p55 or p75
(based on the ’406 application). The amendment also did
not limit claim 1 to the species TNF alpha but rather
retained language regarding binding to the TNF genus
generally.
    About three months after Janssen filed the prelimi-
nary amendment, the examiner mailed an office action
requiring Janssen to elect between species I (which in-
cluded chimeric antibodies and immunoreceptors which
comprise the epitope binding region of an antibody) and
species II (which included immunoreceptor molecules
comprising TNF receptors p55 or p75). The claims di-
rected to species II were originally disclosed and claimed
only in the ’406 application and not in the ’413 applica-
tion. Janssen elected species I.
    The examiner next issued an office action in the ’093
application provisionally rejecting claims on obviousness-
type double patenting grounds over yet another applica-
tion, No. 08/324,799 (“’799 application”). The ’799 appli-
cation is a CIP of the ’102 application. As noted, the ’102
application has the same filing date as the ’093 applica-
tion, and it is similarly a CIP of both the ’406 and ’413
applications. After receiving the double patenting rejec-
tion in the ’093 application, Janssen filed a preliminary
amendment in the ’102 application, cancelling all of the
pending claims and replacing them with seven new claims
6                              IN RE: JANSSEN BIOTECH, INC.

directed to a method of treating Crohn’s disease. Janssen
similarly filed a preliminary amendment in the ’799
application, replacing all of the pending claims with seven
new claims directed to methods of treatment of rheuma-
toid arthritis. The ’799 application issued as U.S. Patent
No. 5,698,195 (“’195 patent”) and, as noted, the ’102
application issued as the ’272 patent. Both the ’272 and
the ’195 patents are reference patents in this appeal.
    Following the examiner’s double patenting rejection in
the ’093 application, Janssen cancelled and amended
claims in that application, including limiting claim 1 to
TNF alpha. The examiner issued another office action
maintaining these rejections and Janssen appealed.
    Janssen then filed another amendment cancelling and
amending claims. Janssen argued that the double patent-
ing rejection over the ’799 application should be with-
drawn because all of the claims in that application had
been cancelled and replaced by seven new claims directed
to methods of treatment of rheumatoid arthritis. Accord-
ingly, Janssen argued, pointing to the October 1993
restriction requirement received in the ’413 application,
that “35 U.S.C. § 121 precludes an obviousness-type
double patenting rejection in this case.” J.A. 13771. In
view of the cancellation of claims in the ’093 and ’799
applications, the examiner withdrew the double patenting
rejection in the ’093 application but continued to reject
the claims on other grounds.
    The ’093 application eventually issued as the ’471 pa-
tent on September 4, 2001, with 9 claims. Claims 1, 3,
and 5–6 are directed to a chimeric antibody specific for
TNF alpha. Claims 2 and 4 are directed to immunoassay
methods for detecting human TNF. Claims 8 and 9 are
directed to polypeptides of particular amino acid sequenc-
es that bind to hTNF alpha.
    Several years later, in 2013, in response to a third-
party request, the PTO instituted reexamination of the
IN RE: JANSSEN BIOTECH, INC.                             7

’471 patent on double patenting grounds over three pa-
tents including the ’272 and ’195 patents (the reference
patents). During the reexamination, Janssen cancelled
claims 8 and 9 and requested that the ’471 patent be
amended to delete the benefit claim to the ’406 applica-
tion. Janssen also requested that the specification, ab-
stract, and drawings of the ’471 patent be conformed to
the ’413 application (i.e., by deleting portions that were
not present in the ’413 application) and that the ’093
application be designated as a divisional of that applica-
tion.
    The PTO entered the amendments for the “purpose of
reexamination” but did not confirm the status of the ’471
patent as a divisional. Whether the amendment would be
effective to alter the nature of the ’471 patent remained a
live issue. The examiner ultimately maintained the
double patenting rejections on the basis that the safe
harbor did not apply. The examiner noted that, although
Janssen had never received issued claims in the ’471
patent on the subject matter originating from the ’406
application, more than thirty-two issued patents “reached
through the ’471 patent for benefit of a prior filing date”
and the “patentability of those claims . . . cannot be de-
termined without reopening examination of those patents
in view of the deletion of the subject matter in the ’471
patent.” J.A. 691. The examiner further concluded that
only the one-way test for double patenting applied be-
cause the PTO was not “solely responsible” for the ’471
patent’s later issuance and that the claims of the ’471
patent are unpatentable under that test.
    The Board affirmed the double patenting rejections.
The Board confirmed that Janssen’s amendments during
the reexamination proceeding were only entered for
“procedural reasons” and that “[t]he Director did not, in
granting the petition, indicate that the effect of the
amendment would be to confirm the ’093 [a]pplication as
a divisional.” J.A. 27. The Board “f[ou]nd no reason to
8                                 IN RE: JANSSEN BIOTECH, INC.

permit [Janssen] now, by amendment, to acquire the
benefit of the safe harbor when [Janssen] voluntar[il]y
and deliberately filed a continuation[-in]-part application
with claims directed to subject matter absent from the
’413 [a]pplication and outside the scope of its restriction.”
J.A. 28. The Board then applied the one-way test for
double patenting because it found that there were at least
four instances where Janssen’s actions “constituted
deliberate and unnecessary actions that lengthened the
prosecution time of the ’093 [a]pplication.” J.A. 33.
    Janssen appeals the Board’s decision. We have juris-
diction pursuant to 28 U.S.C. § 1295(a)(4)(A).
                             II
    The main issue on appeal is whether the safe-harbor
provision of 35 U.S.C. § 121 applies to the ’471 patent and
protects it from invalidation based on the ’272 and ’195
reference patents. If the safe harbor applies, then the
reference patents cannot be used as references against the
’471 patent in a double-patenting rejection. Conversely,
the reference patents are available as references against
the ’471 patent if the safe harbor does not apply. Whether
the requirements of § 121 have been satisfied is a ques-
tion of law that we address de novo. Bristol-Myers Squibb
Co. v. Pharmachemie B.V., 361 F.3d 1343, 1348 n.1 (Fed.
Cir. 2004).
    The safe-harbor provision of § 121 provides as follows:
    A patent issuing on an application with respect to
    which a requirement for restriction under this
    section has been made, or on an application filed
    as a result of such a requirement, shall not be
    used as a reference either in the Patent and
    Trademark Office or in the courts against a divi-
    sional application or against the original applica-
    tion or any patent issued on either of them, if the
IN RE: JANSSEN BIOTECH, INC.                               9

    divisional application is filed before the issuance
    of the patent on the other application.
35 U.S.C. § 121.
    This court follows “a strict application of the plain
language of § 121.” Amgen Inc. v. F. Hoffman-La Roche
Ltd, 580 F.3d 1340, 1353 (Fed. Cir. 2009); see also Geneva
Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373,
1382 (Fed. Cir. 2003) (“Given the potential windfall [a]
patent term extension could provide to a patentee, this
court applies a strict test for application of § 121.” (foot-
note omitted)).
    The § 121 safe harbor, “by its literal terms, protects
only divisional applications (or the original application)
and patents issued on such applications.” Pfizer, Inc. v.
Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir.
2008) (internal quotation marks omitted). Accordingly,
patents issued on CIP applications are not within the
scope of § 121. Id. at 1362. Nor are patents issued on
continuation applications. Amgen, 580 F.3d at 1354. Our
precedent is clear: aside from the original application and
the original patent, the protection afforded by § 121 is
limited to divisional applications and patents issued on
divisional applications. 3 Pfizer, 518 F.3d at 1362.

    3   We recognize that this court has held that a pa-
tent need not have directly issued on a divisional applica-
tion to receive § 121 protection.        Any intervening
continuing applications, however, must descend from a
divisional application filed as a result of a restriction
requirement. See, e.g., Boehringer Ingelheim Int’l GmbH
v. Barr Labs., Inc., 592 F.3d 1340, 1352 (Fed. Cir. 2010)
(intervening divisional application); Amgen, 580 F.3d at
1354 (citing Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d
1569, 1580 (Fed. Cir. 1991)) (intervening continuation
10                               IN RE: JANSSEN BIOTECH, INC.

                             A
    This case presents the question of whether, several
years after a challenged patent issues on a CIP applica-
tion, a patent owner can retroactively bring the chal-
lenged patent within the scope of the § 121 safe harbor by
amending the CIP application during a reexamination
proceeding to redesignate it as a divisional application.
In Searle we answered this question in the reissue con-
text, holding that the patent owner could not take ad-
vantage of the safe-harbor provision simply by
designating the CIP as a divisional application in a reis-
sue application years after the fact. 790 F.3d at 1354–55.
     Leading up to the Searle case, this court in Pfizer con-
cluded that the statutory safe-harbor provision did not
shield a challenged patent when it issued on a CIP and
not a divisional application. Searle, 790 F.3d at 1352
(citing Pfizer, 518 F.3d at 1362). Following the disposition
in Pfizer, the patent owner filed an application with the
PTO seeking reissue of the patent challenged in Pfizer.
Searle, 790 F.3d at 1353. Just as Janssen’s reexamina-
tion amendments do here, the patent owner’s preliminary
amendments accompanying the reissue application delet-
ed portions of the challenged patent’s specification that
were not present in the original application and changed
the designation of the application on which the challenged
patent had issued from a CIP to a divisional application.
Id. The preliminary amendments also cancelled claims
that were not present in the original application. Id. The
PTO eventually allowed the claims of the reissue applica-
tion, which issued as a reissue patent. Id.

application). The effect of intervening applications is not
at issue here because the ’471 patent issued on the ’093
application, which descends directly from the original
application.
IN RE: JANSSEN BIOTECH, INC.                            11

    The patent owner filed suit, alleging infringement of
the reissue patent. Id. at 1353–54. The district court
found that the safe-harbor provision did not apply to the
reissue patent and that the relevant claims were invalid
for obviousness-type double patenting in light of the same
reference patent at issue in Pfizer. Id. at 1354. The
patent owner appealed. Id.
    Applying “a strict test” to determine whether the reis-
sue patent was entitled to § 121 protections, the court in
Searle concluded that, even assuming it was proper to
grant the reissue patent under 35 U.S.C. § 251, the reis-
sue patent was not entitled to safe-harbor protection. Id.
The application on which the challenged patent had
issued was not a divisional because it contained new
matter that was not present in the original application.
Id. at 1354–55. Nor could the nature of that application
be retroactively altered by simply deleting that new
matter. Id. at 1355. Moreover, the court concluded that
the patent owner could not (for purposes of § 121) retroac-
tively relinquish the new matter in the CIP application
after having enjoyed years of patent protection for it. Id.
    We are persuaded by the reasoning in Searle that a
patent owner cannot retroactively bring its challenged
patent within the scope of the safe-harbor provision by
amendment in a reexamination proceeding. 4 In Searle,
the court assumed the reissue patent was properly grant-
ed and still concluded the safe harbor did not apply. Id.
at 1354.     Thus, here too, even assuming Janssen’s

    4   Although Searle involved amendments made un-
der the Patent Act’s reissue provisions rather than the
reexamination provisions, the analysis in Searle is appli-
cable to the effect, if any, of amendments made during
reexamination on the applicability of § 121 to a chal-
lenged patent.
12                              IN RE: JANSSEN BIOTECH, INC.

amendments made during reexamination were to become
effective by way of a reexamination certificate, we con-
clude that the ’471 patent is not entitled to safe-harbor
protection.
    The reissue patent in Searle “[wa]s not entitled to safe
harbor protection, because it did not issue on either the
[original] application or a divisional of the [original]
application.” Id. (emphasis added). The reissue patent
issued on a CIP application, and that CIP application
could not retroactively become, for the purposes of § 121,
a divisional application. We explained that, “despite
being designated as such in the reissue patent,” the CIP
application could not be a divisional of the original appli-
cation because it contained new matter that was not
present in the original application. Id. at 1354–55.
“Simply deleting that new matter from the reissue patent
d[id] not retroactively alter the nature of the [CIP] appli-
cation.” Id. at 1355. Here, following the reasoning in
Searle, once the ’471 patent issued on the ’093 applica-
tion—which, like the application in Searle, at the time of
issuance included new matter not disclosed in the original
application and so was a properly designated CIP—the
’471 patent was barred from safe-harbor protections.
    A strict application of the plain language of § 121 also
supports this holding. Under the language of the statute,
in order to fall within the scope of the safe harbor, a
challenged patent must have “issue[ed] on” a divisional
application. 35 U.S.C. § 121 (stating that a reference
patent “shall not be used as a reference . . . against a
divisional application or against the original application
or any patent issued on either of them” (emphasis added)).
The ’471 patent cannot retroactively become, for the
purposes of § 121, a “patent issued on” a divisional appli-
cation after it already issued on a CIP application; not
even if that CIP application is effectively redesignated as
a divisional application during reexamination. See Searle,
790 F.3d at 1355. For a challenged patent to receive safe-
IN RE: JANSSEN BIOTECH, INC.                              13

harbor protections, the application must be properly
designated as a divisional application, at the very latest,
by the time the challenged patent issues on that applica-
tion.
     Janssen argues that Searle is distinguishable be-
cause, unlike the patent in Searle, no issued claims in the
’471 patent relied upon any of the new matter in the ’093
application. Janssen, therefore, maintains that it never
enjoyed, at the public’s expense, any benefit from having
filed the ’093 application as a CIP of both the ’406 and
’413 applications rather than as a divisional of the ’413
application. We disagree. For example, the examiner
found that Janssen had benefitted because more than
thirty patents issued to Janssen claiming priority to the
’471 patent and/or the ’093 application as a CIP of both
the ’406 and ’413 applications. Determining whether any
of those patents rely on the deleted subject matter for
support cannot be accomplished without reopening exam-
ination of each patent. Cf. Searle, 790 F.3d at 1355
(observing that where a patent owner had obtained for-
eign patent protection based on a PCT application, alter-
ing the scope of the PCT application could call into
question the proper scope of those foreign patents).
    Even if Janssen did not benefit from the period in
which the application was designated as a CIP, we none-
theless find no reason, under the plain language of § 121
or under our precedent, to permit Janssen now, by
amendment, to acquire the benefit of the safe harbor.
    Janssen voluntary and deliberately filed an applica-
tion properly designated as a CIP, having subject matter
not disclosed in the original ’413 application. At no time
during the pendency of the ’093 application did Janssen
request, by submitting amendments or otherwise, that
the relationship of the ’093 application to the ’413 applica-
tion be changed to anything other than a CIP. Janssen
contends that it informed the PTO that the ’093 applica-
14                              IN RE: JANSSEN BIOTECH, INC.

tion was a divisional of the ’413 application because it
“repeatedly” told the PTO that it was prosecuting the ’093
application to pursue examination of a non-elected inven-
tion. As the Board correctly recognized, however, the
statement Janssen references merely states that the
“Preliminary Amendment cancels subject matter which is
drawn to a non-elected invention pursuant to the re-
striction requirement set forth in parent application.”
J.A. 23 (citing J.A. 13856). Importantly, Janssen never
indicated that the remaining subject matter was limited
to only subject matter claimed and disclosed in the ’413
application, nor did the amendment eliminate the claimed
subject matter derived from the ’406 application. Not
until the reexamination amendments did Janssen ever
attempt to delete the subject matter disclosed in the ’406
application from its ’093 application. These statements,
therefore, cannot undo Janssen’s filing the ’093 applica-
tion as a CIP and properly designating it as such. See
Amgen, 580 F.3d at 1354 (declining “to construe ‘division-
al application’ in § 121 to encompass . . . properly filed,
properly designated continuation applications”). And
once the ’471 patent issued on a CIP application, it was
not entitled to safe-harbor protections. 5
                            B
    Janssen argues that our holding today creates a rigid
“divisional as filed” test. Such a test, Janssen argues,
lacks any statutory basis and ignores longstanding PTO
rules and practices that permit applicants to amend the
disclosure and claims of an application after it is filed.

     5 Given our conclusion, we do not consider the
PTO’s alternative argument that § 121 does not apply
because the ’471 patent and the reference patents did not
maintain consonance with the restriction requirement
made in the ’413 application. Pfizer, 518 F.3d at 1362.
IN RE: JANSSEN BIOTECH, INC.                             15

Amending an application to change its relationship to a
prior-filed application—for example, from a CIP to a
divisional—is expressly permitted.           See 37 C.F.R.
§ 1.78(d)(2) (2015) (providing that the specification must
“contain or be amended to contain a reference to each such
prior-filed application” and that “reference also must
identify the relationship of the applications”) (emphasis
added); see also MPEP § 211.03 (permitting the correction
of “a timely submitted benefit claim” by “[c]hanging the
relationship of the applications (e.g., changing . . . from
‘continuation-in-part’ to ‘continuation’ or ‘divisional’)”).
    Janssen points us to a “widely followed practice,”
where an applicant files a copy of the original application
with the same claims as those that were subjected to a
restriction and then files a preliminary amendment
limiting the claims to one or more of the non-elected
inventions prior to the commencement of examination.
This practice is permitted, Janssen argues, by MPEP
§ 714.01(e), which specifically allows references to prior
applications for priority claims to be made after filing.
Janssen also asserts that the PTO does not enforce a rigid
definition that excludes a CIP from ever being considered
also a divisional because it “routinely” allowed applicants
to designate applications as both a CIP and a divisional. 6
     These practices, whether or not they are widely prac-
ticed or even permitted under PTO rules, have no rele-
vance here because Janssen did not follow them. When
filing its ’093 application, Janssen did not file a copy of

    6   Any applications designated as both a CIP and di-
visional application, at the very least under the current
revision of the MPEP, were most likely improperly desig-
nated as such. See MPEP § 201.06 (2015) (“A continua-
tion-in-part application should not be designated as a
divisional application.”).
16                                IN RE: JANSSEN BIOTECH, INC.

the ’413 application with its original claims. Janssen filed
a CIP with claims and subject matter that originated from
both the ’413 and ’406 applications. Although Janssen’s
preliminary amendment may have limited its claims to
one group in the ’413 restriction requirement, Janssen
continued to present claims that relied on subject matter
disclosed in both the ’413 and ’406 applications. Janssen
also never identified the ’093 application as both a divi-
sional application and a CIP application.           Instead,
Janssen repeatedly identified the ’093 application only as
a CIP of both the ’413 and ’406 applications. When the
’471 patent issued, it issued on a CIP application.
    Because the practices Janssen points to are not pre-
sented in this case, we do not decide whether such filing
practices or amendments made prior to issuance—
wherein an application is designated as a divisional
application by the time the challenged patent issues on
that application—would be sufficient to bring the chal-
lenged patent within the scope of the safe-harbor protec-
tions.
                            III
    Because we find that Janssen’s ’471 patent is not enti-
tled to § 121 safe-harbor protections, we must also decide
whether the Board erred when it found that Janssen is
not entitled to the two-way test for obviousness-type
double patenting. The question of whether the one-way
test or the two-way test applies is one of law and is there-
fore reviewed by this court without deference. In re Berg,
140 F.3d 1428, 1432 (Fed. Cir. 1998).
    When determining whether claims are invalid for ob-
viousness-type double patenting, a one-way test is ap-
plied, in which “the examiner asks whether the
application claims are obvious over the patent claims.” In
re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1376
(Fed. Cir. 2008) (quoting Berg, 140 F.3d at 1432). In
“unusual circumstances,” however, a two-way test may
IN RE: JANSSEN BIOTECH, INC.                               17

apply, in which “the examiner also asks whether the
patent claims are obvious over the application claims.”
Id. (quoting Berg, 140 F.3d at 1432). Those unusual
circumstances occur only “when the applicants filed first
for a basic invention and later for an improvement, but,
through no fault of the applicants, the PTO decided the
applications in reverse order of filing, rejecting the basic
application although it would have been allowed if the
applications had been decided in the order of their filing.”
Berg, 140 F.3d at 1432.
    Accordingly, the two-way test is a “narrow exception
to the general rule of the one-way test,” and is only ap-
propriate where (1) a second-filed application issues prior
to a first-filed application, and (2) “the PTO is solely
responsible for the delay” in the issuance of the first-filed
application. Basell, 547 F.3d at 1376–77 (quoting Berg,
140 F.3d at 1437). Because neither of these circumstanc-
es is present here, we are unpersuaded by Janssen’s
assertion that the Board erred by failing to apply a two-
way test for double patenting.
     First, because the ’471 patent and the ’272 patent
were both filed on February 4, 1994, at least for the ’272
patent, the second-filed application issuing prior to a first-
filed application circumstance is not present here. Nor
does Janssen contend that either the ’272 patent or the
’195 patent is directed to “a basic invention” or that the
’471 patent is directed to “an improvement” over an
earlier filed basic invention. Thus, the “essential concern”
that the two-way test is intended to alleviate is not pre-
sent here. Berg, 140 F.3d at 1432.
    Second, the Board found that Janssen took, or failed
to take, several actions that caused the ’471 patent to
issue after the ’272 and ’195 reference patents. The Board
identified four specific instances where Janssen’s “actions
were not just part of the ordinary processing times.”
J.A. 33. These instances were: (1) Janssen’s filing a
18                              IN RE: JANSSEN BIOTECH, INC.

preliminary amendment in the ’093 application, which
contained claims from both the ’406 application and the
’413 application; (2) Janssen’s filing a Notice of Appeal
and waiting one year to file a submission under 37 C.F.R.
§ 1.129(a); (3) Janssen’s waiting more than three years
after the examiner deemed certain claims allowable to
cancel the rejected claims in order to gain allowance; and
(4) Janssen’s adding claims from another application after
a final rejection in this application. We find no error with
regard to the Board’s findings and conclude that Janssen
cannot establish that the PTO is “solely responsible” for
any alleged delay associated with the ’471 claims. For
this reason alone, the two-way test for double patenting
does not apply. We have considered Janssen’s arguments
and find them unpersuasive.
    Because the safe-harbor provision of 35 U.S.C. § 121
does not apply to the ’471 patent to protect it from invali-
dation based on the ’272 and ’195 reference patents, and
because Janssen is not entitled to the two-way test for
obviousness-type double patenting, we affirm the Board’s
rejection of claims 1–7 of the ’471 patent as unpatentable
under the doctrine of obviousness-type double patenting.
                       AFFIRMED