Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01265/USCOURTS-ca13-15-01265-0/pdf.json

Parties Involved:
Michelle K. Lee
Appellee
Pfizer Inc.
Appellant
Wyeth Holdings Corporation
Appellant

Document Text:

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-GBLTRJ, Judge Gerald Bruce Lee.

______________________ 

Decided: January 22, 2016

______________________ 

SIMEON G. PAPACOSTAS, Kirkland & Ellis LLP, Chicago, 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, 

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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 Corporation appeal the district court’s grant of summary judgment 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 interest in the ’768 patent. Pfizer acquired Wyeth in 2009. 

 

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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 exceeding three years; and (iii) a “C-Delay,” which 

awards PTA for delays due to interferences, secrecy orders, and appeals. The USPTO calculates 

PTA by adding the A-, B-, and C-Delays, subtracting 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 notifications under section 132 or a notice of allowance under 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 application.” 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. 

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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 dispute.” 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 utilized 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 statutory 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 

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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 participated 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 requirement 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 respond 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 October 11, 2011, when the PTO issued a Notice of Allowance. On April 10, 2012, the ’894 application issued as 

the ’768 patent, reflecting a total PTA award of 1291 days, 

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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 issuance 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 argument on these cross-motions, the district court issued a 

decision granting the PTO’s motion for summary judgment, 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 November 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

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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 determination 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 “arbitrary, 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 declining 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 Appellants did not waive their argument, but that their argument nonetheless fails on the merits. Accordingly, we 

affirm the judgment of the district court.

A. Waiver 

The PTO argues that Appellants waived their argument that a defective restriction requirement does not 

meet the requirements of Section 132, and therefore 

cannot meet the requirements of § 154(b)(1)(A). Appellants point to excerpts of their summary judgment motion 

where they argue that the PTO’s first restriction requirement “failed to provide information sufficient for the 

applicants to judge the propriety of continuing prosecution.” 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 

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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 statute’s plain meaning, the issue of whether the PTO provided 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 uninformative 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 anticipation under Section 102 satisfied the notice requirements 

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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 statutory 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 restriction requirement failed to satisfy the notice requirement of Section 132 because it failed to classify six 

dependent claims2 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 examiner treated it as though it had “been withdrawn.” J.A. 

A569. Appellants argue that the initial restriction requirement 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.

 

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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 requirement). Viewed as a whole, the restriction requirement 

provided adequate grounds on which the applicants could 

“recogniz[e] and seek[] to counter the grounds for rejection.” 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 omitted from the initial restriction requirement, Wyeth could 

have taken direction for their classification from the fact 

that their respective independent claims were each included 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 classification of an independent claim is omitted from a restriction 

requirement, the fact that the omitted claims here were 

 

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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 incorporates 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 definitions 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 evilimited to dependent claims is a factor that supports our 

conclusion that the initial restriction requirement was 

sufficiently informative to satisfy Section 132.

 

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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 rejection.” 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 application constituted 21 separate and independent “inventions.” 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 inventions [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 transpires thereafter.”). 

The Manual of Patent Examining Procedure (MPEP) 

also supports the PTO’s position that the original restriction requirement satisfied the notice requirements of 

Section 132. The MPEP’s restriction form letter instructs 

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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 otherwise 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 divisional application or against the original application or any patent issued on either of them, if the 

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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 application 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 “inventions” already defined in the initial restriction requirement. 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 reclassification of certain dependent claims. Only when the examiner 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 successful. Thus, Appellants’ argument fails because the 

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PFIZER INC. v. LEE 15

applicants here was never prevented from taking advantage of the Section 121 “safe harbor.” 

Other courts have reached similar conclusions regarding 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 (internal quotation marks omitted). The applicant subsequently 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 additional 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 automatically 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 

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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 ‘compensate patent applicants for certain reductions in patent 

term that are not the fault of the applicant,’ not to guarantee 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 requirement placed the applicants on notice of “the broad statutory 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 

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PFIZER INC. v. LEE 17

calculated the length of PTA for the ’768 patent. Accordingly, we affirm the judgment of the district court. 

AFFIRMED

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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-GBLTRJ, 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 requirement during patent examination contributed to the delay 

in issuance of the patent.

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2 PFIZER INC. v. LEE

The panel majority reasons that Wyeth1 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 requirement 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 correction. 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 reason1 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.

 

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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 colleagues 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 intended 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 February 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.

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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 incomplete 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 appears 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 order 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 period specified in clause (i), (ii), (iii), or (iv), 

as the case may be, until the action described 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 

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PFIZER INC. v. LEE 5

for restriction, see 37 CFR § 1.142 (“If two or more independent 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 invention 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 restriction 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 exactly 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 Section 132.

In re Hughes, 345 F.2d 184 (CCPA 1965), upon which 

Chester relies, does not attempt to define the requirements 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.

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6 PFIZER INC. v. LEE

Several MPEP sections provide details, all to the effect that Section 132 requires completeness of the restriction 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 uncertainty is illustrated here, for the examiner, in the supplemental 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 complete 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 applicant, 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 applicant 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 successfully convinces an Examiner to change a ruling contained 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 Section 154(b)(1)(A).’” Id. at 86 (emphasis in original). In 

UMass there was no allegation that the restriction requirement was incomplete; only that it “ran counter to the 

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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 compensate patent applicants for certain reductions in patent 

term that are not the fault of the applicant.”). My colleagues’ statutory interpretation and application are

contrary to the letter and purpose of the law. I respectfully dissent.

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