United States District Court, E.D. Virginia, Alexandria Division
M. HILTON, UNITED STATES DISTRICT JUDGE
MATTER comes before the Court on Plaintiff's Motion for
Summary Judgment and Defendant's Cross Motion for Summary
Judgment. This action arises from Plaintiff's challenge
of the United States Patent and Trademark Office's
("USPTO") patent term adjustment determination for
United States Patent No. 8, 648, 077 (the "'077
calculating the term of a patent, the USPTO is required to
account for statutorily enumerated delays in the USPTO's
examination of the patent application as well as any amount
of time "during which the applicant failed to engage in
reasonable efforts to conclude prosecution of the
application." 35 U.S.C. § 154(b) (2) (C) (i). To
prevent a patent term's loss of time due to delay caused
by the USPTO, the statutory 20-year patent term is to be
extended by the sum of USPTO delay time minus applicant delay
time. This calculation is referred to as a patent term
Intra-Cellular Therapies, Inc. is the owner and assignee of
all right, title, and interest in thex077 patent.
Thev07 7 patent was issued on February 11, 2014.
In calculating the PTA for the '077 patent, the USPTO
issued a Final Decision on January 9, 2017, maintaining a
determination of 264 days of PTA. This PTA calculation was
based in part on a finding of 142 days of Applicant's
delay during the prosecution. This 142 day delay period was
the sum of four distinct periods of Applicant's delay:
(1) a 90-day period of delay under 37 C.F.R. § 1.704(b);
(2) a 10-day period of delay under 37 C.F.R. §
1.704(c)(10); (3) a 21-day period of delay under 37 C.F.R.
§ 1.704(c) (10); and (4) a 21-day period of delay under
37 C.F.R. § 1.704(b). In this action, Plaintiff
challenges only the fourth period of Applicant's delay.
This 21-day period of delay was calculated under 37 C.F.R.
§ 1.704(b) with respect to Plaintiff s responses to the
USPTO's Final Office Action of April 17, 2013 (the
"Final Office Action"), and Advisory Action of July
26, 2013 (the "Advisory Action") .
dispute between the parties revolves around whether the
Plaintiff properly "replied" to the USPTO's
final rejection of the '077 patent application, which was
communicated in the Final Office Action. The USPTO determined
that Plaintiff failed to properly "reply" within
the statutorily-defined three month period allowed for reply.
Plaintiff, conversely, contends that it did submit a timely
and proper reply on July 17, 2013 (the "July 17, 2013
submission"), and that the USPTO erred when it
determined that the July 17, 2013 submission was not a proper
reply. The USPTO argues that the July 17, 2013 submission was
not a proper reply because it failed to place the '077
patent application in condition for allowance, or, in the
alternative, because it was a "reply having an omission,
" and thus the USPTO's decision to assess applicant
delay until Plaintiff corrected the omissions present in the
July 17, 2013 submission was not arbitrary and capricious.
filed this case on July 7, 2017, under 35 U.S.C. §
154(b)(4)(A), the Administrative Procedures Act, and the
Fifth Amendment of the U.S. Constitution. Plaintiff then
filed a Motion for Summary Judgment on October 2, 2017,
arguing that there is no dispute of material facts as to the
dates or content of the relevant office actions and responses
thereto, and therefore the only issues to be resolved are
issues of law. The USPTO filed a Cross Motion for Summary
Judgment on October 25, 2017, arguing that because the APA
"confines judicial review of executive branch decisions
to the administrative record of proceedings before the
pertinent agency[, ] . . . there can be no genuine issue of
material fact in an APA action, and the legal questions
presented in [an APA] action are therefore ripe for
resolution on cross-motions for summary judgment."
Genetics & IVF Inst, v. Kappos, 801 F.Supp.2d
497, 502 (E.D. Va. 2011).
Federal Rule of Civil Procedure 56, a court should grant
summary judgment if the pleadings and evidence show that
there is no genuine dispute as to any material fact and that
the moving party is entitled to judgment as a matter of law.
Fed.R.Civ.P. 56(c); see also Celotex Corp. v.
Catrett, 477 U.S. 317, 322 (1986). In reviewing a motion
for summary judgment, the court views the facts in the light
most favorable to the non-moving party. See Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). Once a
motion for summary judgment is properly made, the opposing
party has the burden to show that a genuine dispute of
material fact exists. See Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 586-87 (1986). The
Court finds there is no genuine dispute of material fact and
this case is ripe for summary judgment.
the APA, a "reviewing court shall . . . hold unlawful
and set aside agency action, findings, and conclusions found
to be arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law." 5. U.S.C. §
706(2) (A). This standard "is the most deferential of
the APA standards of review, and is only met where a
reviewing court can conclude with definite and firm
conviction that a clear error of judgment or a mistake has
been committed." President & Fellows of
Harvard Coll. v. Lee, 589 Fed.Appx. 982, 984
(Fed. Cir. 2014).
statute relevant to PTA calculation is 35 U.S.c. §
154(b). This statute defines applicant delay as "the
period of time during which the applicant failed to engage in
reasonable efforts to conclude prosecution of the
application." 35 U.S.C. § 154(b) (2) (C) (i) . One
such failure to engage in reasonable efforts occurs when an
applicant takes longer than three months to respond to a
notice from the USPTO. Id. § 154 (b) (2) (C)
(ii) . Further, the statute instructs the USPTO Director to
"prescribe regulations establishing procedures for the
application for and determination of patent term
adjustments." Id. § 154(b)(3)(A). The
Director is instructed 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."
Id. § 154(b) (2) (C)(iii). The USPTO has
accordingly promulgated regulations pursuant to that
authority. 37 C.F.R. §§ 1.702-04.
these regulations, §§ 1.702 and 1.703, describe the
grounds for assessing examination delay. Id. at
§§ 1.702-03. Section 1.704(a) then provides for PTA
to be reduced by any period of applicant delay, and §
1.704(b) explains that any period of time in excess of three
months taken by the applicant to reply to any notice or
action by the USPTO making any rejection, objection,
argument, or other request is assessed as applicant delay.
Id. at § 1.704. Finally, § 1.7
04(c) provides a list of "exemplary
circumstances that constitute" applicant delay, noting
that the USPTO could also reduce the period of adjustment on
a case-by-case basis for "conduct that interferes with
the Office's ability to process or examine an application
. even if such conduct is not specifically" listed in
1.704 (c) . Id.
April 17, 2013, the USPTO issued a final action rejecting the
application for the '077 patent. Specifically, of the
thirty-one claims that were still pending in the application,
ten claims were withdrawn, thirteen claims were objected to,
and eight claims were rejected. No claims were allowed.
Admin. R. at 281-97 (Dkt. No. 12}.
17, 2013, exactly three months after the issuance of the
USPTO's final action, Plaintiff filed an amendment in
response to the final action. Id. at 306-29.
Plaintiff amended the majority of the claims in an effort to
overcome the examiner's objections and rejections;
however, it also presented arguments as to certain of the
examiner's objections and rejections, and it added one
new claim. Id. at 319-20.
26, 2013, the USPTO issued an Advisory Action, which
indicated that the July 17, 2013 submission failed to
overcome all of the rejections of record. Five claims
remained rejected, Claim 34 was objected to based on an
informality, and seventeen claims remained objected to based
on their dependency on a rejected claim. The Advisory Action
stated that the time period in which to file a compliant
reply to the final rejection continues to run from the
mailing date of the final rejection. Id. at 331-32.
August 7, 2013, Plaintiff filed a supplemental amendment,
which cancelled and further amended claims to finally
overcome all of the examiner's outstanding objections and
rejections. Id. at 334-65. On August 20, 2013, the
USPTO issued a Notice of Allowance regarding the application
for the '077 ...