Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-01159/USCOURTS-ca13-14-01159-0/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 

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United States Court of Appeals 

for the Federal Circuit ______________________ 

GILEAD SCIENCES, INC.,

Plaintiff-Appellant

v.

MICHELLE K. LEE, DEPUTY DIRECTOR, 

UNITED STATES PATENT AND TRADEMARK 

OFFICE, ACTING UNDER SECRETARY OF 

COMMERCE FOR INTELLECTUAL PROPERTY,

Defendant-Appellee

______________________ 

2014-1159

______________________ 

Appeal from the United States District Court for the 

Eastern District of Virginia in No. 1:12-cv-01090-LO-IDD, 

Judge Liam O’Grady.

______________________ 

Decided: February 26, 2015

______________________ 

JONATHAN ELLOIT SINGER, Fish & Richardson P.C., 

Minneapolis, MN, argued for plaintiff-appellant. Also 

represented by AHMED JAMAL DAVIS, Washington, DC; 

CRAIG EARL COUNTRYMAN, San Diego, CA. 

DAVID MOSKOWITZ, Criminal Division, Fraud Section, 

United States Department of Justice, Washington, DC, 

argued for defendant-appellee. Also represented by DANA 

J. BOENTE; BRIAN THOMAS RACILLA, NATHAN K. KELLEY,

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2 GILEAD SCIENCES, INC. v. LEE

JEREMIAH S. HELM, Office of the Solicitors, United States 

Patent and Trademark Office, Alexandria, VA.

______________________ 

Before DYK, WALLACH, and HUGHES, Circuit Judges.

WALLACH, Circuit Judge

Gilead Sciences, Inc. (“Gilead”) appeals the decision of 

the United States District Court for the Eastern District 

of Virginia granting summary judgment to the Director of 

the United States Patent and Trademark Office (“PTO”) 

on whether it properly calculated the Patent Term Adjustment (“PTA”) period for U.S. Patent No. 8,148,374 

(“the ’374 patent”). See Gilead Scis., Inc., v. Rea, 976 

F.Supp.2d 833 (2013) (“Gilead I”). Because the district 

court properly granted the director’s motion for summary 

judgment, this court affirms. 

BACKGROUND

I. 

In 1994, Congress changed the method of how a patent term is calculated. See Pub. L. No. 103-465, § 532, 

108 Stat. 4809, 4984 (1994) (amending 35 U.S.C. § 154). 

Under the previous statute, a patent’s term ran from the 

date the patent issued until the end of a period measured 

from that date––generally seventeen years, subject to 

certain extensions. See Pub. L. No. 98-417, § 201, 98 Stat. 

1585, 1589–99 (1984) (adding 35 U.S.C. § 156 to provide 

for extensions of the term of patents covering inventions 

that were subject to pre-market regulatory review). 

Under the 1994 statutory provision, the patent term still 

begins on the date of issuance, but generally ends twenty 

years after the patent application was filed. Pub. L. No. 

103-465, § 532, 108 Stat. 4809, 4984 (1994) (amending 35 

U.S.C. § 154). Under the new statute, because the duration of a patent is no longer solely predicated on its date of 

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GILEAD SCIENCES, INC. v. LEE 3

issuance, delays in the patent examination process decrease the length of an applicant’s patent term.

In order to address this issue, in 1999, Congress enacted provisions under which patent applicants may seek 

PTAs for delays caused by the PTO between the filing and 

issuance dates of the patent application. See Pub. L. No. 

106–113, § 1000(a)(9), 113 Stat. 1501, 1536 (1999). Specifically, 35 U.S.C. § 154(b), titled “Adjustment of patent 

term,” divides PTO actions which cause delay into three 

general categories. Under category A, titled “Guarantee of 

prompt Patent and Trademark Office responses” (“A 

Delay”), a patent owner may seek a PTA if, inter alia, the 

PTO does not issue a notification under § 132 or provide a 

notice of allowance under § 151 within fourteen months of 

an application filing.1 35 U.S.C. § 154(b)(1)(A)(i). The 

statute provides that “the term of the patent shall be 

extended 1 day for each day” the PTO does not meet its 

response deadlines. Id. § 154(b)(1)(A). 

Category B, titled “Guarantee of no more than 3–year 

application pendency” (“B Delay”), allows for a one-day 

1 According to 35 U.S.C. § 132(a): 

Whenever, on examination, any claim for a patent 

is rejected, or any objection or requirement made, 

the Director shall notify the applicant thereof, 

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; and if after receiving such notice, the 

applicant persists in his claim for a patent, with 

or without amendment, the application shall be 

reexamined. No amendment shall introduce new 

matter into the disclosure of the invention.

 

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4 GILEAD SCIENCES, INC. v. LEE

extension for each day the PTO fails to issue a patent 

three years after the actual filing date of the application, 

subject to certain limitations under § 154(b)(1)(B)(i)-(iii). 

Id. § 154(b)(1)(B). Finally, category C, titled “Guarantee 

of adjustments for delays due to derivation proceedings, 

secrecy orders, and appeals” (“C Delay”), provides PTAs

for delays excluded from the B Delay. Id. § 154(b)(1)(C). 

The C Delay accounts for each day of delay due to an 

interference, secrecy order, or successful appeal. 

The statute also accounts for delays attributed to applicant conduct. This appeal involves § 154(b)(2)(C), 

which reduces PTAs by accounting for delays caused by 

the patent applicant. The statutory provision provides: 

(C) Reduction of period of adjustment.— 

(i) The period of adjustment of the term of a patent under paragraph (1) shall be reduced by a period equal to the period of time during which the 

applicant failed to engage in reasonable efforts to 

conclude prosecution of the application.

(ii) With respect to adjustments to patent term 

made under the authority of paragraph (1)(B), an 

applicant shall be deemed to have failed to engage 

in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of 3 months 

that are taken to respond to a notice from the Office making any rejection, objection, argument, or 

other request, measuring such 3-month period 

from the date the notice was given or mailed to 

the applicant.

(iii) The Director shall prescribe regulations establishing the circumstances that constitute a 

failure of an applicant to engage in reasonable efforts to conclude processing or examination of an 

application.

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GILEAD SCIENCES, INC. v. LEE 5

Id. § 154(b)(2)(C)(i)-(iii) (2011) (emphasis added). 

II.

Gilead owns the ’374 patent covering the compound 

cobicistat. The patent relates generally to “compounds 

and pharmaceutical compositions which . . . improve [] the 

pharmacokinetics of a co-administered drug, and methods 

of . . . improving [] the pharmacokinetics of a drug by coadministration of the compounds with the drug.” ’374 

patent col. 1 ll. 18–22. Gilead filed its application for the 

’374 patent on February 22, 2008. 

When a Patent Examiner (“Examiner”) believes there 

is more than one patentably distinct invention recited in

the claims, the Examiner issues a “restriction requirement” requesting the patent applicant to select a single 

invention. See 37 C.F.R. § 1.142 (2007). 

On November 18, 2009, the PTO issued a restriction 

requirement, dividing Gilead’s claims into four groups of 

inventions and directing it to select a subset of its claimed 

inventions before further examination. Gilead responded 

to the restriction requirement on February 18, 2010 and 

selected one of the four groups of inventions for examination. While waiting for the PTO to issue a first office 

action on the merits, Gilead filed a supplemental information disclosure statement (“IDS”) on April 16, 2010, 

which disclosed two other co-pending Gilead patent 

applications. The PTO issued a notice of allowance on 

July 29, 2011 and the ’374 patent issued on April 3, 2012. 

Gilead I, at 3.

Both parties agree Gilead is entitled to a PTA as a result of the PTO’s failure to meet the statutorily-mandated 

timeliness requirements of § 154 in issuing the ’374 

patent. In calculating the appropriate PTA, the PTO 

issued Gilead 245 days of “A Delay” for its failure to meet 

the mandated statutory response deadlines and 406 days 

of “B Delay” for its “failure to issue the patent within 

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6 GILEAD SCIENCES, INC. v. LEE

three years of the application’s filing date.” Id. The 651 

combined days were subsequently reduced by overlapping 

and applicant-induced delay. The first reduction amounted to thirty-five days for overlapping delay. Id. at 3–4, see

35 U.S.C. § 154(b)(2)(A). The second reduction was for an 

additional fifty-seven days. The fifty-seven day reduction

was assessed for the period between Gilead’s initial reply 

to the restriction requirement and its filing of a supplemental IDS on April 16, 2010. Gilead I, at 4, see 35 

U.S.C. § 154(b)(2)(C). In total, the PTO granted Gilead a 

PTA of 559 days. Id. 

On October 27, 2011, Gilead contested the PTO’s assessment of the fifty-seven day applicant delay. Gilead 

argued its filing of the supplemental IDS did not cause 

any actual delay and therefore should not have been 

subtracted from its PTA. The PTO rejected this argument, countering, “under [35 U.S.C. §] 132, the first 

action mailed by the [PTO] was the restriction requirement mailed [on] November 18, 2009.” J.A. 130. Therefore, according to the PTO, Gilead’s filing of a 

supplemental IDS after it had filed a response to the 

restriction requirement constituted a failure to engage in 

a reasonable effort to conclude prosecution as required by 

37 C.F.R. § 1.704(c)(8). Id. According to C.F.R. 

§ 1.704(c)(8): 

Circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude 

processing or examination of an application . . . 

include the following circumstances [:] . . . Submission of a supplemental reply or other paper, 

other than a supplemental reply or other paper expressly requested by the examiner, after a reply has 

been filed, in which case the period of adjustment 

set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the 

date the initial reply was filed and ending on the 

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date that the supplemental reply or other such 

paper was filed.

37 C.F.R. § 1.704(c)(8) (emphasis added). 

In its appeal to the district court, Gilead argued the 

PTO’s interpretation and application of 35 U.S.C. § 154(b) 

was “arbitrary, capricious, an abuse of discretion, or 

otherwise not in accordance with the law and in excess of 

statutory jurisdiction, authority, or limitation. Gilead I, 

at 4 (quoting 5 U.S.C. § 706(2)(A) (1966)). The parties 

subsequently filed cross-motions for summary judgment, 

agreeing only questions of law were in dispute. Id. 

Because it found Gilead did not succeed in showing the 

PTO’s interpretation was unreasonable, the district court 

granted the PTO’s motion for summary judgment. Id. at 

9. 

Gilead timely files this appeal. This court has jurisdiction pursuant to 28 U.S.C. § 1295(a)(1) (2012).

DISCUSSION

I. Standard of Review

This court reviews a district court’s grant of summary 

judgment de novo. Summary judgment decisions are 

reviewed under the law of the regional circuit. See

Charles Mach. Works, Inc. v. Vermeer Mfg. Co., 723 F. 3d 

1376, 1378 (Fed. Cir. 2013). PTA decisions of the PTO are 

reviewed in accordance with the Administrative Procedure Act (“APA”). See 35 U.S.C. § 154(b)(4)(A). Under the 

review provision of the APA applicable here, a court may

set aside the PTO’s actions only if they are “arbitrary, 

capricious, an abuse of discretion, or otherwise not in 

accordance with law.” 5 U.S.C. § 706(2)(A). When reviewing an agency’s statutory interpretation, this court applies 

the two-step framework established in Chevron, U.S.A., 

Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 

837 (1984). In re Cuozzo Speed Techs., LLC, No. 2014-

1301, 2015 WL 448667, at *8 (Fed. Cir. Feb. 4, 2015) 

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8 GILEAD SCIENCES, INC. v. LEE

(citing United States v. Mead Corp., 533 U.S. 218, 226–27 

(2001) and Wilder v. Merit Sys. Prot. Bd., 675 F.3d 1319, 

1322 (Fed. Cir. 2012)). 

II. Congress Did Not Address the Precise Question at 

Issue

On appeal, Gilead challenges the district court’s denial of its motion for summary judgment. Gilead argues the 

PTA statute only allows for adjustments in instances 

where the applicant’s conduct “actually delays the conclusion of prosecution.” Appellant’s Br. 11 (emphasis added). 

First, Gilead argues § 154(b)(2)(C)(i) of the statute,

which provides that any PTA for PTO delay will be reduced by “the period of time during which the applicant 

failed to engage in reasonable efforts to conclude prosecution of the application” (emphasis added), when read in 

context with surrounding statutory language, requires 

applicant behavior resulting in actual delay. Id. at 11–12. 

Second, Gilead points to the statutory purpose and legislative history in order to support the argument that 

Congress intended to penalize only applicant conduct that 

causes actual delay. Id. at 12. 

Step-one of Chevron asks whether Congress “directly 

addressed the precise question at issue.” Chevron, 467 

U.S. at 842. The district court determined “the precise 

issue is whether filing a supplemental IDS after submitting a reply to a restriction requirement constitutes a 

failure to engage in reasonable efforts to conclude prosecution of the application.” Gilead I, at 5 (internal quotation marks omitted). On appeal to this court, Gilead 

never actually addresses whether the district court’s 

determination of the precise question at issue is correct. 

Additionally, Gilead does not contend that the plain 

language of the statute answers the precise question at 

issue as framed by the district court. Instead, Gilead’s 

Chevron step-one argument merely asserts that when 

read in context with the surrounding statutory language, 

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GILEAD SCIENCES, INC. v. LEE 9

“[t]he statutory text, purpose, and legislative history all 

demonstrate that the PTO is permitted to reduce patent 

term adjustment only when an applicant’s behavior 

actually delays the conclusion of prosecution.” Appellant’s 

Br. 11. 

“[T]he ‘starting point in every case involving construction of a statute is the language itself.’” United States v. 

Hohri, 482 U.S. 64, 69 (1987) (quoting Kelly v. Robinson, 

479 U.S. 36, 43 (1986)). “Absent a clearly expressed 

legislative intention to the contrary, [the statute’s plain] 

language must ordinarily be regarded as conclusive.” 

Consumer Prod. Safety Comm’n v. GTE Sylvania, Inc., 

447 U.S. 102, 108 (1980). Here Gilead’s contention is 

problematic because nothing in the plain language of the 

statute suggests reasonableness requires the applicant’s 

behavior to have an effect on when the prosecution ends. 

Furthermore, Gilead emphasizes the term “conclude 

prosecution,” while ignoring that the statute’s “reasonable 

efforts” language focuses on applicant conduct as opposed 

to the results of such conduct. See 35 U.S.C. 

§ 154(b)(2)(C)(i). Finally, Gilead does not point to any 

language in the statute equating “reasonable efforts to 

conclude prosecution of the application” as described by 

§ 154(b)(2)(C)(i) to applicant conduct requiring actual 

delay. 

Gilead next argues “[a]nother statutory provision confirms Congress’s intent to tie the ‘reasonable efforts’ 

clause to applicant behavior that causes actual delay.” 

Appellant’s Br. 12. Specifically, Gilead contends “Congress identified one specific type of applicant behavior as 

a failure ‘to engage in reasonable efforts to conclude 

processing or examination’ of the application––taking 

over 3 months to respond to an office action.” Id. (quoting 

35 U.S.C. § 154(b)(2)(C)(ii). According to Gilead, by 

including a specific timeframe, this statutory provision 

requires actual delay. Therefore, Gilead argues Congress 

must have intended for the PTO to penalize only appliCase: 14-1159 Document: 36-2 Page: 9 Filed: 02/26/2015
10 GILEAD SCIENCES, INC. v. LEE

cant behavior causing actual delay. Gilead urges this 

court to apply the rule of ejusdem generis to 

§ 154(b)(2)(C)(ii) in finding that Congress intended the

results of the applicant behavior described in that provision applies generally to § 154(b)(2)(C)(i). 

The PTO contends the interpretative rule of ejusdem 

generis is inapplicable in this context. Specifically, the 

PTO argues “[ejusdem generis] applies only to ‘a general 

or collective term following a list of specific items to which 

a particular statutory command is applicable.’” Appellee’s 

Br. 34 (quoting CSX Transp., Inc. v. Ala. Dep’t. of Revenue, 131 S. Ct. 1101, 1113 (2011)). 

As this court has previously held, “[u]nder the rule of 

ejusdem generis, which means ‘of the same kind,’ where 

an enumeration of specific things is followed by a general 

word or phrase, the general word or phrase is held to refer 

to things of the same kind as those specified.” Sports 

Graphics, Inc. v. United States, 24 F.3d 1390, 1392 (Fed. 

Cir. 1994). “We typically use ejusdem generis to ensure 

that a general word will not render specific words meaningless.” CSX Transp., Inc., 131 S. Ct. at 1113 (2011) 

(citing Circuit City Stores, Inc. v. Adams, 532 U.S. 105, 

114-15 (2001)). 

Here, ejusdem generis is inapplicable to this statutory 

provision. Subsection 154(b)(2)(C)(ii) provides one instance where Congress provided an example of applicant 

delay. However, the third subsection of the statute does 

not provide a general word or phrase, but rather employs 

broad language in directing the PTO to prescribe other 

instances in which applicant behavior that “constitutes a 

failure of an applicant to engage in reasonable efforts to 

conclude processing or examination of an application.” 35 

U.S.C. § 154(b)(2)(C)(iii). Therefore, the plain language of 

the statutory text does not support Gilead’s contention 

that Congress meant to restrict such conduct solely to 

applicant conduct causing delay. 

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GILEAD SCIENCES, INC. v. LEE 11

In an effort to discern Congress’s intent, this court 

looks to “traditional tools of statutory construction.” See 

Timex V.I., Inc. v. United States, 157 F.3d 879, 882 (Fed. 

Cir. 1998) (quoting Chevron, 467 U.S. at 843 n.9). “Beyond the statute’s text, those ‘tools’ include the statute’s 

structure, canons of statutory construction, and legislative history.” Id. 

Gilead argues this court should find the “reasonable 

efforts” provision of the statute requires actual delay 

based on the statute’s purpose and legislative history. In 

addition to its presentation of the statute’s legislative 

history, see H.R. Rep. No. 106-287, at 50 (1999), Gilead 

relies on two House committee reports for bills that were 

not enacted. See H.R. Rep. No. 104-784, at 19–20, 33, 66–

68 (1996) (discussing the Moorhead-Schroeder Patent

Reform Act, H.R. 3460, 104th Cong. § 208 (2d Sess. 

1996)); H.R. Rep. No. 105-39, at 17-18, 32-33, 64-67 (1997) 

(discussing 21st Century Patent System Improvement Act, 

H.R. 400, 105th Cong. (1st Sess. 1997)). 

The Supreme Court has held “[e]xtrinsic materials 

have a role in statutory interpretation only to the extent 

they shed a reliable light on the enacting Legislature’s 

understanding of otherwise ambiguous terms.” Exxon 

Mobil Corp. v. Allapattah Servs., Inc., 545 U.S. 546, 568

(2005). Here, Gilead does not contend any provision in 

the statute is ambiguous. “[T]he authoritative statement 

is the statutory text, not the legislative history or any 

other extrinsic material.” Id. Moreover, the weight 

attached to extrinsic materials is de minimis when the 

legislative history is not from the enacting Congress. See

United States v. Price, 361 U.S. 304, 313 (1960); United 

States v. United Mine Workers of Am., 330 U.S. 258, 282

(1947). 

Indeed, the House committee reports cited by Gilead 

do not support its argument. On the contrary, the reports 

lend greater support to the PTO’s construction of the 

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12 GILEAD SCIENCES, INC. v. LEE

statute. Nothing in them suggests Congress intended to 

restrict PTAs based on applicant conduct to actions causing actual delay. For example, a House committee report 

in support of the Moorhead-Schroeder Patent Reform Act 

states “[t]he ‘reasonable efforts’ clause is an effort to avoid 

the submarine patent problem. The intent of the Committee is that only the most egregious and obvious delay 

tactics will go unrewarded by this provision.” H.R. Rep. 

No. 104-784, at 67. Based on this provision in the report, 

Gilead contends “egregious and obvious delay tactics” 

suggests Congress only intended to penalize applicant 

conduct resulting in actual delay. Appellant’s Br. at 14. 

However, by referencing obvious delay tactics, without 

addressing the result of such tactics, it appears Congress’s 

primary intent was to penalize applicant conduct as 

opposed to the results of such conduct. 

The House committee report in support of the PTA 

bill that was actually enacted emphasized that the statute 

was intended to penalize “[o]nly those who purposely 

manipulate the system to delay the issuance of their 

patents.” H.R. Rep. No. 106-287, at 50 (emphasis added); 

see American Inventors Protection Act of 1999, H.R. 1907, 

106th Cong. § 302 (1999). Gilead contends this language 

supports its argument that Congress specifically targeted 

applicant behavior resulting in delay.

Adoption of Gilead’s interpretation of the statute necessarily leads to an illogical distinction between applicants whose conduct is intended to cause delay, but who 

nonetheless fail, from those whose conduct incidentally 

results in causing actual delay. In such a scenario, egregious and obvious delay tactics would remain unsanctioned merely because they do not result in actual delay. 

Thus, because the legislative history of the statute does 

not support the finding that Congress aimed to distinguish between patent applicants whose conduct attempts 

to delay issuance of a patent from those whose conduct 

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GILEAD SCIENCES, INC. v. LEE 13

actually results in a delay, this court rejects Gilead’s 

attempt to read it into the statute. 

Because Congress has not addressed the precise question at issue in this case––whether a failure to engage in 

reasonable efforts requires conduct that actually causes 

delay––this court must proceed to an analysis under 

Chevron step-two. 

III. The PTO’s Interpretation and Application of the 

Statute Is Permissible

In step-two, Chevron requires determination of

“whether the [PTO’s] answer is based on a permissible 

construction of the statute.” Chevron, 467 U.S. at 842–43. 

At this stage of the Chevron analysis, judicial deference to 

an agency’s construction of a statutory scheme is afforded 

considerable weight. Id. at 844. Chevron teaches that 

when Congress explicitly leaves a gap for an agency to fill, 

“[s]uch legislative regulations are given controlling weight 

unless they are arbitrary, capricious, or manifestly contrary to the statute.” Id. Therefore, this court is required 

to accept the agency’s construction of the statute even if 

the agency’s reading differs from what the court believes 

is the best statutory interpretation. Id. 

Gilead’s Chevron step-two argument parallels its 

Chevron step-one argument, and for the same reasons 

outlined above, this court rejects its contentions. Congress expressly delegated authority to the PTO by granting authority to “[t]he Director [to] prescribe regulations 

establishing the circumstances that constitute a failure of 

an applicant to engage in reasonable efforts to conclude 

processing or examination of an application.” 35 U.S.C. 

§ 154(b)(2)(C)(iii). As permitted by statute, the PTO 

promulgated 37 C.F.R. § 1.704(c)(8), which encompasses 

the precise situation in this case––the filing of a supplemental IDS after submission of a reply to a restriction 

requirement. Such broad language demonstrates Congress intended the PTO to employ its expertise in identiCase: 14-1159 Document: 36-2 Page: 13 Filed: 02/26/2015
14 GILEAD SCIENCES, INC. v. LEE

fying applicant conduct demonstrating a lack of “reasonable efforts to conclude processing or examination of an 

application.” Id. 

Therefore, this court finds that a reasonable interpretation of the statute is that Congress intended to sanction 

not only applicant conduct or behavior that result in 

actual delay, but also those having the potential to result 

in delay irrespective of whether such delay actually 

occurred. 

Gilead’s argument also fails because it frames the issue solely in terms of the patentee’s application, without 

recognizing that an Examiner is required to review a 

significant number of applications during a limited period 

of time. As the PTO argued before the district court, “a 

supplemental reply or paper often causes delay not only 

in processing an examination of the particular applicant’s 

application, but also with the processing and examination 

of other applications before the examiner.” Gilead I, at 7. 

Although an applicant’s conduct may not actually result 

in delaying the issuance of that applicant’s patent, such 

conduct may have negative externalities for other patent 

applicants because it could result in delaying the issuance 

of their patents.2 

Gilead next argues the PTO’s interpretation of the 

statute is unreasonable. According to Gilead, “[e]ven 

2 Gilead argues that actual delay did not occur because the Examiner had not yet begun reviewing its 

patent application before its supplemental filing. An 

examiner, however, before receiving a supplemental 

filing, may think the patent application file is complete

and therefore severely underestimate the time required to 

complete the patentee’s application. In doing so, the 

Examiner may unintentionally lengthen the review time 

for other pending applications.

 

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under a Chevron step[-two] analysis, the PTO’s application of 37 C.F.R. § 1.704(c)(8) cannot stand” because “any 

gap or ambiguity left by Congress has only one reasonable 

resolution—reductions cannot apply to applicant actions 

that do not cause actual delay in concluding prosecution.” 

Appellant’s Br at 16. Specifically, Gilead contends the 

regulation is impermissibly overbroad and contrary to 

Congress’s intentions because it “sweep[s] in [applicant] 

conduct that does not cause delay.” Id. at 24.

As the district court noted, the conduct penalized under the regulation interferes with the PTO’s ability to 

conclude the application process because of significant 

time constraints faced by the PTO. Because the A Delay 

provision of the statute penalizes the PTO if the examiner 

fails to respond within four months of the applicant’s 

response to a restriction requirement, any relevant information received after an initial response to a restriction 

requirement “interferes with the [PTO’s] ability to process 

an application.” Gilead I, at 7. As the district court 

found, “[a] supplemental IDS, such as the one that Gilead 

submitted, [may] force[] an examiner to go back and 

review the application again, while still trying to meet his 

or her timeliness obligations under § 154.” Id. at 8. 

Finally, Gilead contends the regulation treats similarly-situated patent applicants differently. Specifically, it 

argues the regulation “unreasonably treats applicants 

who receive a restriction requirement differently from 

those who do not” because in the event both applicants 

file an IDS before the first office action on the merits, 

“[t]he PTO penalizes [only] the first applicant by treating 

the IDS as a ‘supplemental reply’ that triggers a reduced 

adjustment.” Appellant’s Br. 19. 

The statute expressly requires the PTO to respond to 

a reply under 35 U.S.C. § 132 within four months after 

the date the reply is filed. 35 U.S.C. § 154(b)(1)(A)(ii). 

Because the PTO characterizes restriction requirements 

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16 GILEAD SCIENCES, INC. v. LEE

as § 132 notifications, it has a significantly reduced window of time to reply to the patent applicant. See id. § 154 

(b)(1)(A)(i). The difference between the two hypothetical 

patent applicants as presented by Gilead is that the PTO 

is not statutorily mandated to respond to the applicant 

who submits a supplemental IDS, but who did not receive 

a restriction requirement within the four month window 

as required by the statute. Id. The regulation is a reasonable interpretation of the statute because the filing of 

a supplemental IDS after an initial reply to a restriction 

requirement further adds to the list of documents the 

PTO must consider before responding to the restriction 

requirement. Therefore, the additional documents make 

it increasingly difficult for the PTO to satisfy the statutorily-mandated time requirement stipulated in 

§ 154(b)(1)(A)(ii). 

Because this court finds the PTO’s construction of the 

statute reasonable, we reject Gilead’s contention that the 

regulation is overbroad and an unreasonable interpretation of the statute.

CONCLUSION

For the foregoing reasons, the district court’s decision 

is

AFFIRMED

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