Pfizer, Inc. v. Lee

United States Court of Appeals
for the Federal Circuit
______________________

PFIZER, INC., A DELAWARE CORPORATION,
WYETH HOLDINGS CORPORATION, A MAINE
CORPORATION,
Plaintiffs-Appellants

v.

MICHELLE K. LEE, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Defendant-Appellee
______________________

2015-1265
______________________

Appeal from the United States District Court for the
Eastern District of Virginia in No. 1:12-cv-01131-GBL-
TRJ, Judge Gerald Bruce Lee.
______________________

Decided: January 22, 2016
______________________

SIMEON G. PAPACOSTAS, Kirkland & Ellis LLP, Chica-
go, IL, argued for plaintiffs-appellants. Also represented
by PATRICIA A. CARSON, DANIEL FORCHHEIMER, New York,
NY.

DENNIS C. BARGHAAN, JR., Office of the United States
Attorney, Eastern District of Virginia, Alexandria, VA,
2 PFIZER INC. v. LEE

argued for defendant-appellee. Also represented by DANA
J. BOENTE; KAKOLI CAPRIHAN, BRIAN RACILLA, SYDNEY O.
JOHNSON, JR., NATHAN K. KELLEY, Office of the Solicitor,
United States Patent and Trademark Office, Alexandria,
VA.
______________________

Before NEWMAN, DYK, and O’MALLEY, Circuit Judges.
Opinion for the court filed Circuit Judge O’MALLEY.
Dissenting opinion filed Circuit Judge NEWMAN.
O’MALLEY, Circuit Judge.
Appellants Pfizer, Inc. and Wyeth Holdings Corpora-
tion appeal the district court’s grant of summary judg-
ment in favor of the United States Patent and Trademark
Office (“PTO”) on the issue of whether the PTO properly
calculated the length of a patent term adjustment (“PTA”)
for U.S. Patent No. 8,153,768 (the “’768 patent”). 1 For the
reasons below, we affirm the judgment of the district
court.
BACKGROUND
A. Statutory Framework for Patent Term Adjustment
A patent has a term of twenty years from the patent
application’s effective filing date. 35 U.S.C. § 154(a)(2).
Thus, an issued patent’s twenty-year term is measured
from the filing date of the parent patent application. An
issued patent’s enforceable life thus depends on the
length of the PTO’s examination of a patent application.
To account for any undue delays in patent examination
caused by the PTO, Congress established a system of

1 Wyeth is the assignee of all rights, title, and in-
terest in the ’768 patent. Pfizer acquired Wyeth in 2009.
PFIZER INC. v. LEE 3

patent term adjustment to compensate inventors for lost
time on their patent term resulting from such delays.
The Patent Term Guarantee Act (“the Act”), 35 U.S.C.
§ 154(b), provides for the restoration of patent term in
three circumstances:
(i) an “A-Delay,” which awards PTA for delays
arising from the USPTO’s failure to act by certain
examination deadlines; (ii) a “B-Delay,” which
awards PTA for an application pendency exceed-
ing three years; and (iii) a “C-Delay,” which
awards PTA for delays due to interferences, secre-
cy orders, and appeals. The USPTO calculates
PTA by adding the A-, B-, and C-Delays, subtract-
ing any overlapping days, and then subtracting
any days attributable to applicant delay.
Pfizer, Inc. v. Lee, No. 12-cv-01131, 2014 U.S. Dist. LEXIS
184554, at *4-5 (E.D. Va. Nov. 6, 2014) (“District Court
Opinion”) (citing Wyeth v. Kappos, 591 F.3d 1364, 1367
(Fed. Cir. 2010)). It is “A Delay” that is at issue in this
appeal. With respect to A Delay, the Act provides for
restoration of patent term “if the issue of an original
patent is delayed due to the failure of the Patent and
Trademark Office to provide at least one of the notifica-
tions under section 132 or a notice of allowance un-
der section 151” within the times specified in the statute.
35 U.S.C. § 154(b)(1)(A) (emphasis added). Section 132 in
turn provides that, if a patent examiner finds that a
patent application does not comply with the standards of
patentability, the examiner will issue an office action with
respect to the application, “stating the reasons for such
rejection, or objection or requirement, together with such
information and references as may be useful in judging of
the propriety of continuing the prosecution of his applica-
tion.” Id. § 132. Thus, the Act provides that A Delay will
not accrue when the PTO “provide[s] at least one of the
notifications under section 132.” Id.
4 PFIZER INC. v. LEE

When a patent is ready to issue, the PTO determines
whether any PTA delay has accrued, and informs the
applicant regarding the length of any term to be restored
to the issued patent. An applicant can appeal the PTO’s
determination of PTA by filing an action in the United
States District Court for the Eastern District of Virginia.
35 U.S.C. § 154(b)(4). We have jurisdiction over an appeal
from a district court’s decision relating to PTA. 28 U.S.C.
§§ 1295(a)(1), (a)(4)(C).
B. Factual Background
As Appellants assert, “[t]his appeal presents a pure
question of statutory interpretation; no facts are in dis-
pute.” Appellants Br. at 17. On May 2, 2003, Wyeth filed
Patent Application No. 10/428,894 (“’894 application”)
entitled “Calicheamicin Derivative-Carrier Conjugates,”
which generally claimed a pharmacological method uti-
lized in the treatment of cancer. The ’894 application
eventually issued as the ’768 patent on April 10, 2012. At
the time of filing, pursuant to 37 C.F.R. § 1.136(a)(3),
Wyeth filed an authorization for the PTO to charge all
required fees necessary for it to qualify automatically for
all authorized extensions of time during the pendency of
the ’894 application. See 37 C.F.R. § 1.136(a)(3). On July
28, 2003, the PTO mailed a Notice to File Missing Parts of
Nonprovisional Application. Wyeth filed the missing
parts of its application on December 8, 2003. The statuto-
ry deadline for the PTO to issue its first office action
expired on July 2, 2004, fourteen (14) months from the
date the application was filed. On August 5, 2005, having
received no office action, Wyeth sent a letter to the PTO
asking when an office action on the merits might be
expected.
On August 10, 2005, 404 days after the July 2, 2004
deadline, the PTO mailed a restriction requirement. A
restriction requirement informs the applicant that “two or
more independent and distinct inventions are claimed in
PFIZER INC. v. LEE 5

one application,” and that the applicant is required to
elect one of the inventions if the applicant wishes to
continue prosecuting the application. 35 U.S.C. § 121.
Generally, a restriction requirement would be considered
an office action under Section 132 because it informs the
applicant of reasons why its claims are considered to be
directed to separate inventions. The deadline for Wyeth
to reply to the restriction requirement was extended
automatically for up to six months based on Wyeth’s
previously filed authorization for extension of time.
Accordingly, the deadline for Wyeth to respond was
February 10, 2006. On February 6, 2006, Wyeth partici-
pated in a telephone interview with the Examiner and
explained that the restriction requirement had omitted
claims 75, 76, and 103-106 from its categorization of the
various claims in the application. During the interview,
the Examiner acknowledged that the restriction require-
ment was not complete; he agreed to withdraw it and
issue a corrected restriction requirement. Joint Appendix
(“J.A.”) A579-80.
The PTO issued a corrected restriction requirement
on February 23, 2006, 601 days after the July 2, 2004
deadline. Appellants were given a new deadline to re-
spond to the corrected restriction requirement, which was
also extended automatically to six months. On May 22,
2006, Wyeth filed its response.
Later in the course of prosecution, the PTO delayed
the mailing of a separate office action with respect to the
applicants’ Request for Continued Examination (“RCE”).
The PTO’s delay with respect to the RCE amounted to 280
days of additional A Delay. See J.A. A2085-86. The
propriety of that calculation is not at issue in this appeal.
Prosecution of the ’894 application continued until Oc-
tober 11, 2011, when the PTO issued a Notice of Allow-
ance. On April 10, 2012, the ’894 application issued as
the ’768 patent, reflecting a total PTA award of 1291 days,
6 PFIZER INC. v. LEE

of which 684 days were attributed to A Delay. The PTO
calculated this A Delay based upon: (1) the issuance of the
examiner’s first restriction requirement on August 10,
2005, 404 days beyond fourteen months from the date on
which Wyeth filed the ’894 application, and (2) the issu-
ance of the response to Wyeth’s RCE on April 22, 2011,
280 days beyond four months from the date on which the
RCE was filed. The PTO did not award A Delay for the
197 days that elapsed between the issuance of the first
restriction requirement and the mailing of the corrected
restriction requirement. It is that 197 days which are at
issue.
C. Procedural Background
On October 5, 2012, Appellants brought an action in
the Eastern District of Virginia seeking a judgment
correcting the PTO’s Award of A Delay for the ’768 patent
to account for the 197-day period from August 10, 2005,
the date on which the PTO mailed the first restriction
requirement, to February 23, 2006, the date on which the
PTO mailed the corrected restriction requirement. The
parties cross-moved for summary judgment on the issue of
whether the PTO should have granted additional A Delay
for the 197 day period in question.
On November 6, 2014, after full briefing and oral ar-
gument on these cross-motions, the district court issued a
decision granting the PTO’s motion for summary judg-
ment, and denying Appellants’ motion for the same relief.
District Court Opinion, 2014 U.S. Dist. LEXIS 184554, at
*4-5. The district court entered final judgment on No-
vember 12, 2014, resolving all pending issues in the
underlying action. Appellants timely appealed.
STANDARD OF REVIEW
We review the district court’s grant of summary
judgment de novo, “applying the same standard as the
district court.” See Voter Verified, Inc. v. Premier Election
PFIZER INC. v. LEE 7

Sols., Inc., 698 F.3d 1374, 1379 (Fed. Cir. 2012). The
merits of Pfizer’s challenge to the PTO’s PTA determina-
tion are governed by those standards employed by the
Administrative Procedure Act (“APA”), see 5 U.S.C.
§ 154(b)(4)(A). Accordingly, we must affirm the PTO’s
patent term adjustment determination unless it is “arbi-
trary, capricious, an abuse of discretion, or otherwise not
in accordance with law.” 5 U.S.C. § 706; Centech Grp. v.
United States, 554 F.3d 1029, 1037 (Fed. Cir. 2009).
DISCUSSION
Appellants appeal the district court’s judgment declin-
ing to award Appellants restoration of patent term for the
extra 197-day period in question. Appellants argue that
the PTO’s original restriction requirement failed to satisfy
the notice requirement of Section 132. As a threshold
matter, the PTO argues that Appellants waived this
argument. For the following reasons, we find that Appel-
lants did not waive their argument, but that their argu-
ment nonetheless fails on the merits. Accordingly, we
affirm the judgment of the district court.
A. Waiver
The PTO argues that Appellants waived their argu-
ment that a defective restriction requirement does not
meet the requirements of Section 132, and therefore
cannot meet the requirements of § 154(b)(1)(A). Appel-
lants point to excerpts of their summary judgment motion
where they argue that the PTO’s first restriction require-
ment “failed to provide information sufficient for the
applicants to judge the propriety of continuing prosecu-
tion.” Brief in Support of Pfizer’s Motion for Summary
Judgment at 26, Pfizer, Inc. v. Lee, 1:12-cv-1131 (E.D. Va.
June 13, 2014), ECF No. 29. Appellants further point to
statements their counsel made during oral argument
before the district court that “Section 132 of Title 35 not
only defines what constitutes a response but also what
such a response must contain at a minimum in order to
8 PFIZER INC. v. LEE

qualify as a response under the statute.” J.A. A2293 at
4:24-6:25.
Waiver exists to ensure that “the lower court be fairly
put on notice as to the substance of the issue.” Nelson v.
Adams USA, Inc., 529 U.S. 460, 469-70 (2000). “Once a
federal claim is properly presented, a party can make any
argument in support of that claim; parties are not limited
to the precise arguments they made below.” Yee v. City of
Escondido, Cal., 503 U.S. 519, 534-35 (1992). Here, there
is ample evidence that Appellants raised their Section 132
arguments in their summary judgment brief and at oral
argument. And, the district court addressed Appellants’
arguments, finding that “[t]he language of the statute
requires only that the PTO ‘provide at least one of the
notifications under section 132,’ in order to stop the
clock.” Pfizer, 2014 U.S. Dist. LEXIS 184554, at *20. We
therefore conclude that Appellants did not waive their
Section 132 argument.
B. The District Court Properly Granted Summary
Judgment in Favor of the PTO
We now address the merits of Appellants’ arguments.
The Act provides that A Delay will stop accruing when the
PTO “provide[s] at least one of the notifications under
Section 132.” 35 U.S.C. § 154(b). Thus, under the stat-
ute’s plain meaning, the issue of whether the PTO provid-
ed a notification under Section 132 is dispositive of this
case. White v. United States, 543 F.3d 1330, 1337 (Fed.
Cir. 2008) (“It is a bedrock canon of statutory construction
that our judicial inquiry ends where statutory language is
plain and unambiguous.”). In Chester v. Miller, we held
that “Section 132 is violated when a rejection is so unin-
formative that it prevents the applicant from recognizing
and seeking to counter the grounds for rejection.” 906
F.2d 1574, 1578 (Fed. Cir. 1990). Chester concerned
whether an examiner’s rejection on the basis of anticipa-
tion under Section 102 satisfied the notice requirements
PFIZER INC. v. LEE 9

of Section 132. We noted that, to make a successful
rejection under Section 132, the PTO does not have to
“explicitly preempt every possible response to a section
102 rejection.” Id. Instead, Section 132 merely requires
that an applicant “at least be informed of the broad statu-
tory basis for [the rejection of] his claims, so that he may
determine what the issues are on which he can or should
produce evidence.” Id. (quoting In re Hughes, 345 F.2d
184, 185 (CCPA 1965)). Applying these principles, we
found the examiner’s rejection in Chester sufficient to
satisfy the requirements of Section 132. Id. (“In the
instant case, the reasons supporting the prima facie case
of anticipation did put Chester on notice. The [examiner]
specified exactly which claims read on exactly what prior
art.”).
Here, Appellants argue that the PTO’s original re-
striction requirement failed to satisfy the notice require-
ment of Section 132 because it failed to classify six
dependent claims 2 into the examiner’s defined invention
groups, and thus failed to place the applicants on notice of
the restriction requirement as to those dependent claims.
See J.A. A461-65. Appellants next argue that the initial
restriction requirement was not valid because the exam-
iner treated it as though it had “been withdrawn.” J.A.
A569. Appellants argue that the initial restriction re-
quirement should accordingly be treated as a “non-event”
for purposes of determining whether Section 132 was
satisfied, and, hence, whether A Delay should have ceased
accruing under the Act.

2 Namely, dependent claims 75-76 and 103-106
were omitted from the initial restriction requirement.
Claims 75-76 were both dependent from claim 73, and
claims 103-06 were all dependent from claim 98. J.A.
A363-66.
10 PFIZER INC. v. LEE

We find Appellants’ arguments unpersuasive. As in
Chester, the examiner’s initial restriction requirement
satisfied the statutory notice requirement because it
informed the applicant of “the broad statutory basis for
[the rejection of] his claims.” Chester, 906 F.2d at 1578.
Here, the examiner’s detailed descriptions of the 21
distinct invention groups outlined in the examiner’s
initial restriction requirement were clear, providing
sufficient information to which the applicants could have
responded. Indeed, the applicants never challenged the
content of the invention groups defined by the examiner.
And, significantly, the examiner’s defined invention
groups remained identical between the two restriction
requirements. Compare J.A. A461-65 (initial restriction
requirement), with A569-73 (revised restriction require-
ment). Viewed as a whole, the restriction requirement
provided adequate grounds on which the applicants could
“recogniz[e] and seek[] to counter the grounds for rejec-
tion.” Chester, 906 F.2d at 1578. Therefore, because the
examiner clearly defined to the applicants the invention
groups available for election and further prosecution, the
applicants were placed on sufficient notice of the reasons
for the examiner’s restriction requirement.
As for the six claims whose classifications were omit-
ted from the initial restriction requirement, Wyeth could
have taken direction for their classification from the fact
that their respective independent claims were each in-
cluded in the initial restriction requirement. See J.A.
A461-65. Here, the dependent claims would naturally
have been classified in a subset of the invention groups to
which the claims they depend from belong. 3

3 While we do not hold that the notice requirement
of Section 132 can never be satisfied where the classifica-
tion of an independent claim is omitted from a restriction
requirement, the fact that the omitted claims here were
PFIZER INC. v. LEE 11

To illustrate, independent claim 98 was placed in
eight groups in the original restriction requirement:
Groups VI, VII, VIII, IX, X, XI, XII and XIII. J.A. A462-
63. The classification of claims 103-106, which all depend
from claim 98, were omitted from the first restriction
requirement. In the second restriction requirement, the
examiner classified claims 103-105 into Group VI, and
claim 106 into Group XI. Responding to the corrected
restriction requirement, Wyeth elected Group VI, and also
asserted that claim 106 should be reclassified from Group
XI into Group VI:
Applicants hereby elect Group VI, claims 28-33,
37-44, 48, 54, 61-64, 91-98, 103-105, and 107-112
with traverse. Applicants respectfully submit that
. . . . claim 106 depends from claim 98 and incor-
porates all of the limitations in claim 98 that the
Examiner has found sufficient to include claim 98
in Group VI.
J.A. A582. The examiner accepted Appellants’ suggested
classification of claim 106 into Group VI, at which point
the examiner stated that the restriction requirement is
“deemed to be proper and is made FINAL.” J.A. A589. At
no time did the applicants dispute the examiner’s defini-
tions of the 21 distinct inventions themselves. Because
the descriptions of the inventions set forth in the original
restriction requirement remained identical when the
examiner issued the second restriction requirement, we
agree with the PTO that it did not require significant
guesswork for the applicants to determine where the
inadvertently omitted claims belonged. Wyeth’s success
in convincing the examiner to reclassify one of the omitted
claims after the issuance of the correction further evi-

limited to dependent claims is a factor that supports our
conclusion that the initial restriction requirement was
sufficiently informative to satisfy Section 132.
12 PFIZER INC. v. LEE

dences that the initial restriction requirement did not
preclude the applicants from determining where the
omitted claims should have been placed and was not “so
uninformative that it prevent[ed] the applicant from
recognizing and seeking to counter the grounds for rejec-
tion.” Chester, 906 F.2d at 1578. Indeed, Appellants
never identified any reason why they would not have been
able to suggest the proposed classification of the omitted
dependent claims in the first instance by responding with
a traverse to the initial restriction requirement.
Although the examiner did not classify the omitted six
dependent claims into one of the 21 defined invention
groups, the examiner made clear on the face of the initial
restriction requirement that he intended to account for all
pending claims. Specifically, the examiner noted in the
office action Summary that “Claims 1-144 are pending in
the application,” and that “Claims 1-144 are subject to
restriction and/or election requirement.” J.A. A460. The
original restriction requirement further articulated the
reasons that the examiner believed that the ’894 applica-
tion constituted 21 separate and independent “inven-
tions.” J.A. A461-65. The examiner’s original restriction
requirement thus satisfied the notice requirement of
Section 132 because, pursuant to Chester, it provided both
the “broad statutory basis” for the examiner’s rejection,
namely, that “[r]estriction to one of the following inven-
tions [was] required under 35 U.S.C. § 121,” and was
sufficiently informative to allow Wyeth to counter the
grounds for rejection. J.A. A461 (emphasis added); see
also Univ. of Mass. v. Kappos, 903 F. Supp. 2d 77 (D.D.C.
2012) (“UMass”) (“[T]he A delay clock stops ticking when
the first Office action is issued, regardless of what tran-
spires thereafter.”).
The Manual of Patent Examining Procedure (MPEP)
also supports the PTO’s position that the original re-
striction requirement satisfied the notice requirements of
Section 132. The MPEP’s restriction form letter instructs
PFIZER INC. v. LEE 13

PTO examiners to “look for omitted claims” in issuing a
restriction requirement, and provides that a restriction
requirement is not automatically invalid simply because
it fails to account for a particular claim:
While every claim should be accounted for, the
omission to group a claim, or placing a claim in
the wrong group will not affect the propriety of a
final requirement where the requirement is oth-
erwise proper and the correct disposition of the
omitted or erroneously grouped claim is clear.
MPEP § 814. Appellants argue that the examiner’s
omission of the six dependent claims failed to comply with
the MPEP’s guidance because it was not clear into which
group the omitted claims should fall. As discussed above,
however, we believe the initial restriction requirement
sufficiently informed the applicants of the grounds for
rejection and clearly defined the invention groups, such
that the applicants could and in fact did determine into
which group the omitted claims should be classified.
Therefore, we reject Appellants’ argument.
Appellants next argue that Section 121’s “safe harbor”
provision supports their position that the examiner’s
initial restriction requirement failed to satisfy Section
132. That provision protects patentees from certain types
of invalidity attacks, such as obviousness-type double
patenting, with respect to applications and/or patents
that issue separately as a result of a PTO restriction
requirement. As provided in Section 121:
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
14 PFIZER INC. v. LEE

divisional application is filed before the issuance
of the patent on the other application . . . .
35 U.S.C. § 121. Appellants argue that, to preserve
immunity under the “safe harbor,” the patentee must
ensure that the patent issuing from the divisional appli-
cation passes a strict “consonance” test. Appellants Br. at
28-30. “Consonance requires that the line of demarcation
between the ‘independent and distinct inventions’ that
prompted the restriction requirement be maintained. . . .
Where that line is crossed the prohibition of the third
sentence of Section 121 does not apply.” Gerber Garment
Tech., Inc. v. Lectra Sys., 916 F.2d 683, 688 (Fed. Cir.
1990). Appellants accordingly argue that, because the
initial restriction requirement omitted certain claims,
there was no clear “line of demarcation” between the
various inventions, and there was thus no way in which
the applicants could have taken advantage of Section
121’s immunity based on the examiner’s initial restriction
requirement.
As the PTO correctly notes, however, the examiner
did nothing in the revised restriction requirement to
modify the nature or description of the 21 distinct “inven-
tions” already defined in the initial restriction require-
ment. And, importantly, the restriction requirement at
issue was not made “final” until the applicants responded
and the examiner took action on the response. Here, the
applicants responded to the restriction requirement by
electing an invention group and suggesting reclassifica-
tion of certain dependent claims. Only when the examin-
er adopted the suggested regrouping was the examiner’s
restriction requirement “made FINAL.” J.A. A589. Had
Wyeth advocated for its suggested regrouping in response
to the initial restriction requirement, rather than the
corrected restriction requirement, there is nothing to
suggest that Wyeth would not have been similarly suc-
cessful. Thus, Appellants’ argument fails because the
PFIZER INC. v. LEE 15

applicants here was never prevented from taking ad-
vantage of the Section 121 “safe harbor.”
Other courts have reached similar conclusions regard-
ing the requirements of Section 132. As the district court
correctly noted, this case is similar to UMass. In UMass,
the examiner issued a first restriction requirement, but
failed to divide the antibody claims “based on whether the
antibody . . . could specifically bind to either C. difficile
toxin A or toxin B.” UMass, 903 F. Supp. 2d at 81 (inter-
nal quotation marks omitted). The applicant subsequent-
ly convinced the examiner that the restriction
requirement was erroneous because of this failure, and
the examiner issued a new restriction requirement. Id.
Upon patent issuance, the PTO declined to award addi-
tional time for A Delay for the period between the initial
restriction requirement and the corrected restriction
requirement. UMass then brought suit requesting that
the court award it this additional time for A Delay. The
UMass court granted summary judgment in favor of the
PTO, finding that the PTO’s decision declining to award
time for additional A Delay was neither arbitrary nor
capricious. See id. at 86-87. In so holding, the UMass
court explained that the prosecution process involves a
“back and forth” process wherein applicants advocate for
the broadest and strongest claims, and examiners provide
reasons for rejecting unsupported or unpatentable claims.
Id. at 86. While the process of patent prosecution often
involves changes in both the applicant’s and examiner’s
positions, an examiner’s reissuance of an office action in
response to an applicant’s suggestion does not automati-
cally mean that an application has been “delayed” for
purposes of patent term adjustment. Id. at 86.
These principles are not controverted by the two cases
upon which Appellants rely, In re: Patent No. 7,803,385,
Matthew C. Coffee, Decision on Application For Patent
Term Adjustment, May 24, 2012 (“Oncolytics”) and
Janssen Pharmaceutica, N.V. v. Rea, 928 F. Supp. 2d 103
16 PFIZER INC. v. LEE

(D.D.C. 2013). We need not determine whether those
cases were decided correctly. Janssen and Oncolytics are
distinguishable from the present scenario because in both
cases the examiner sua sponte rescinded and replaced the
issued restriction requirements without explanation and
without prompting from the applicants. See Oncolytics,
J.A. A2151-52; Janssen, 928 F. Supp. 2d at 104. Finding
that the examiners’ actions in Janssen were outside the
normal “give-and-take process” of patent prosecution, the
PTO awarded the applicants their requested time for PTA
delay. See In re: Patent No. 7,741,356, Breslin et al.,
Decision Upon Remand and Reconsideration of Patent
Term Adjustment and Notice of Intent to Issue Certificate
of Correction, J.A. A2403; see also Oncolytics, J.A. A2154
(awarding PTA for A Delay).
Here, similar to UMass, and in contrast to Janssen
and Oncolytics, the applicants’ and examiner’s exchanges
concerning the challenged restriction requirement were
part of the typical “back and forth” process of patent
prosecution. The underlying “purpose of PTA is to ‘com-
pensate patent applicants for certain reductions in patent
term that are not the fault of the applicant,’ not to guar-
antee the correctness of the agency’s every decision.”
UMass, 903 F. Supp. 2d at 86 (citing H.R. Rep. No. 106-
464, at 125 (1999) (Conf. Rep.)) (emphasis added). As
explained above, because the initial restriction require-
ment placed the applicants on notice of “the broad statu-
tory basis for [the rejection of their] claims,” Chester, 906
F.2d at 1578, the restriction requirement satisfied the
notice requirement of Section 132. Thus, we conclude
that Appellants’ alleged delay is not the type of error for
which the Act was intended to compensate.
CONCLUSION
For the foregoing reasons, we find that the district
court did not err in granting summary judgment in favor
of the PTO on the issue of whether the PTO properly
PFIZER INC. v. LEE 17

calculated the length of PTA for the ’768 patent. Accord-
ingly, we affirm the judgment of the district court.
AFFIRMED
 United States Court of Appeals
for the Federal Circuit
______________________

PFIZER INC., A DELAWARE CORPORATION,
WYETH HOLDINGS CORPORATION, A MAINE
CORPORATION,
Plaintiffs-Appellants

v.

MICHELLE K. LEE, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Defendant-Appellee
______________________

2015-1265
______________________

Appeal from the United States District Court for the
Eastern District of Virginia in No. 1:12-cv-01131-GBL-
TRJ, Judge Gerald Bruce Lee.
______________________
NEWMAN, Circuit Judge, dissenting.
I respectfully dissent. The panel majority’s ruling on
patent term adjustment is in conflict with the Patent Act,
for the PTO’s admittedly incomplete restriction require-
ment during patent examination contributed to the delay
in issuance of the patent.
2 PFIZER INC. v. LEE

The panel majority reasons that Wyeth 1 could have or
should have filed a speculative response to the flawed
restriction requirement, on the premise that Wyeth
should have guessed as to which of the 21 groups the
examiner would have chosen for each of the six claims
that the examiner erroneously omitted from the require-
ment for restriction. 2 On the premise that Wyeth might
have guessed correctly and that the examiner might have
proceeded with the prosecution without correcting his
error, my colleagues refuse to include the period of actual
delay in the adjustment of the patent term.
Instead of the highly irregular action conjured by the
panel majority—an action of uncertain propriety and
unlikely responsiveness, an action that could well have
backfired, see 37 C.F.R. 1.135(b) (an incomplete reply
leads to abandonment of the application); MPEP
§ 711.02—Wyeth telephoned the examiner. The examiner
immediately recognized his error, withdrew the flawed
Office action, and promptly issued a corrected Office
action. The panel majority apparently believes that these
events were unnecessary and that Wyeth was at fault in
seeking a corrected official action, and thus must suffer
denial of the statutory term adjustment for the additional
delay.
Thus the panel majority refuses to count the period of
delay consumed by the examiner’s error and its correc-
tion. However, such prosecution delay is within the
statutory conditions for Patent Term Adjustment, 35
U.S.C. §154. The delay occurred, and it cannot be reason-

1 The ‘786 patent is assigned to Wyeth Holdings
Corporation, a wholly owned subsidiary of Pfizer, Inc.
The patent owner is herein designated as “Wyeth.”
2 In instructing as to restriction requirements, the
Manual of Patent Examining Procedure states that “every
claim should be accounted for.” MPEP § 814.
PFIZER INC. v. LEE 3

ably disputed that the applicant and the examiner acted
appropriately to cure the examiner’s error.
Despite the PTO’s admission of its error, my col-
leagues propose that the applicant should have proceeded
as if the incorrect restriction requirement were correct
“because the initial restriction requirement placed the
applicant on notice of ‘the broad statutory basis for [the
rejection of] his claims,’ Chester, 906 F.2d at 1578, the
restriction requirement satisfied the notice requirement of
Section 132.” Maj. Op. at 16. Thus the panel majority
holds that this admitted PTO-caused delay must be
treated as if it did not occur, although it necessarily
delayed prosecution, for the applicant could not reliably
elect which claims to prosecute when some claims had
been omitted by the examiner.
The issue is not whether the applicant could have
guessed where among the 21 groups the examiner intend-
ed to put claims 75, 76, 103, 104, 105, and 106. Nor is the
issue whether the error was harmless (the PTO does not
argue that its error was harmless), for it is not disputed
that the error delayed prosecution. The PTO does not
argue that the prosecution could have proceeded in the
absence of PTO correction of its failure to account for
every claim. The issue is simply whether the delay that
necessarily ensued is an “‘A’ Delay” subject to inclusion in
the term adjustment.
The Wyeth patent application was completed and filed
on December 8, 2003. The 14-month deadline for PTO
issuance of the first official action was not met, and the
incomplete initial restriction requirement was issued by
the PTO on August 10, 2005, with response due on Feb-
ruary 10, 2006. Wyeth phoned the examiner on February
6, 2006, pointing out the error. The examiner withdrew
the flawed restriction requirement, and issued a corrected
restriction requirement on February 23, 2006. The patent
issued on April 10, 2012.
4 PFIZER INC. v. LEE

The PTO issued a Patent Term Adjustment of 1201
days. Pfizer seeks to increase the adjustment by 197
days, measured as the period from the examiner’s incom-
plete restriction requirement on August 10, 2005 to the
issuance of the corrected restriction requirement on
February 23, 2006. It is not disputed that the pendency
period was lengthened by this amount.
The panel majority holds that this period of delay
should be attributed to the applicant, not the PTO. This
is indeed curious, for the applicant made no error. The
panel majority holds that PTO error does not count if the
applicant could have figured out what the examiner might
have done if he had not erred. The panel majority ap-
pears to believe that this would have eliminated the delay
consumed by the correction of the error. However, the
prosecution was delayed by the PTO’s error.
Patent Term Adjustment was enacted into law in or-
der to compensate for prosecution delays, for patent life is
measured from the initial filing date, but patent rights do
not arise until the patent is granted. The statute states:
35 U.S.C. §154(b) Adjustment of patent term.—
(1) Patent term guarantees.—
****
the term of the patent shall be extended 1
day for each day after the end of the peri-
od specified in clause (i), (ii), (iii), or (iv),
as the case may be, until the action de-
scribed in such clause is taken.
By statute, Patent Term Adjustment accumulates until
the PTO issues a notification under Section 132. 35
U.S.C. § 154(b)(1)(A)(i). Section 132 requires a complete
Office action, see 37 C.F.R. § 1.104(b) (“The examiner’s
action will be complete as to all matters . . . .”); MPEP
§ 707.07 (same). Office actions also include requirements
PFIZER INC. v. LEE 5

for restriction, see 37 CFR § 1.142 (“If two or more inde-
pendent and distinct inventions 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 inven-
tion to which the claims will be restricted”); MPEP § 707
(Office action may include restriction requirements); see
also Responding to Office Actions, USPTO,
http://www.uspto.gov/patents-maintaining-patent/
responding-office-actions (“Office actions include a re-
striction requirement, a non-final Office action, and a
final Office action.”).
Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990) does
not hold otherwise. There, the examiner “specified exact-
ly which claims read on exactly what prior art.” Id. at
1578. The patent applicant argued that the examiner
“had not specified that the . . . reference provided written
description or enablement of the subject matter of the
rejected claims.” Id. at 1577. The court held only that
Section 132 does not require the PTO “to state specifically
that a prior art reference describes and enables claims
rejected as anticipated.” Id. at 1578. In Chester, the court
concluded that the Office action was complete, not that a
less-than-complete Office action would comply with Sec-
tion 132.
In re Hughes, 345 F.2d 184 (CCPA 1965), upon which
Chester relies, does not attempt to define the require-
ments of Section 132. There, although the examiner
rejected claims under Section 102, the Board rejected the
same claims under Section 103 without notifying the
applicant that the statutory basis for the rejection had
changed. Id. at 185. The CCPA observed that “[i]t seems
basic to the concept of procedural due process that an
applicant at least be informed of the broad statutory basis
for rejecting his claim.” Id. Section 132, the CCPA noted,
was intended to ensure compliance with at least this bare
minimum. Id.
6 PFIZER INC. v. LEE

Several MPEP sections provide details, all to the ef-
fect that Section 132 requires completeness of the re-
striction requirement as to all of the claims. See MPEP
§ 814 (duty to account for all claims), § 815 (duty to make
restriction requirement complete). Here the restriction
was facially incomplete. The applicant is not required to
guess, to fill in the blanks erroneously left by the PTO.
The applicant’s guess cannot bind the PTO. That uncer-
tainty is illustrated here, for the examiner, in the sup-
plemental restriction, classified claim 106 in Group XI
whereas the applicant, in its response, believed that claim
106 belonged in Group VI.
Rather than guess, the applicant is entitled to a com-
plete Office action. See 37 C.F.R. § 1.104(b). Here, the
PTO provided an incomplete action. The delay caused by
such a scenario should not be charged against the patent
applicant, nor should the applicant be prejudiced by the
examiner’s error. The panel majority erroneously holds
that term adjustment is not available because the appli-
cant, not the PTO, spotted the PTO’s error. See Maj. Op.
at 16 (distinguishing Janssen and Oncolytics on such
grounds). Whether the examiner’s actions “were outside
the normal ‘give-and-take process’ of patent prosecution,”
id., should not turn on who recognized the error.
Importantly, this is not a case where a patent appli-
cant persuaded an examiner to withdraw a rejection or
restriction on the merits. This case is unlike University of
Massachusetts v. Kappos, 903 F. Supp. 2d 77 (D.D.C.
2012) (“UMass”), where the district court stated the issue
as “whether, as a matter of law, when an applicant suc-
cessfully convinces an Examiner to change a ruling con-
tained in an Office action, regardless of whether it is
classified as a vacatur, that renders the first Office action
‘a nullity for purposes of calculating A delay under Sec-
tion 154(b)(1)(A).’” Id. at 86 (emphasis in original). In
UMass there was no allegation that the restriction re-
quirement was incomplete; only that it “ran counter to the
PFIZER INC. v. LEE 7

classification scheme devised by plaintiffs.” Id. at 81.
During telephone conversations, the applicant convinced
the examiner to change the original groupings. Id.
UMass does not support the proposition that a facially
incomplete Office action does not count for patent term
adjustment.
The statutory purpose is clear: when patent issuance
is delayed because of proceedings that are not the fault of
the applicant, the patent term is extended to compensate
for the delay. H.R. Rep No. 106-287, at 49 (1999) (“Title
III amends the provisions in the Patent Act that compen-
sate patent applicants for certain reductions in patent
term that are not the fault of the applicant.”). My col-
leagues’ statutory interpretation and application are
contrary to the letter and purpose of the law. I respectful-
ly dissent.