        NOTE: This disposition is nonprecedential

  United States Court of Appeals
      for the Federal Circuit
               __________________________

                 M. R. MIKKILINENI,
                  Plaintiff-Appellant,
                            v.
 ROBERT STOLL, COMMISSIONER OF PATENTS,
             Defendant-Appellee.
               __________________________

                       2010-1362
               __________________________

   Appeal from the United States District Court for the
Eastern District of Virginia in case no. 09-CV-1412, Judge
Leonie M. Brinkema..
              ___________________________

               Decided: November 9, 2010
              ___________________________

   M.R. MIKKILINENI, of Washington, DC, pro se.

    RAYMOND T. CHEN, Solicitor, Office of the Solicitor,
United States Patent and Trademark Office, of Alexan-
dria, Virginia, for the defendant-appellee. With him on
the brief were MARY L. KELLY and SCOTT C.
WEIDENFELLER, Associate Solicitors.
                __________________________
MIKKILINENI   v. STOLL                                   2


       Before GAJARSA, LINN, and DYK, Circuit Judges.
PER CURIAM.
    M. R. Mikkilineni (“Mikkilineni”) appeals from a deci-
sion of the U.S. District Court for the Eastern District of
Virginia dismissing his claims with prejudice under
Federal Rules of Civil Procedure 12(b)(1) and (6). Mik-
kilineni v. Stoll, No. 09-CV-1412 (E.D. Va. Apr. 30, 2010).
We affirm.
                         BACKGROUND
    Mikkilineni filed a patent application which discloses
and claims “a method to fall-asleep by learning to use the
process-algorithm in the brain [to] transform brain-
neurons into a different[]physical state and produce
melatonin and serotonin . . . without the use of drugs.”
Appellee’s App. A64–65. Mikkilineni’s claims were re-
jected in a non-final rejection under 35 U.S.C. § 101 as
non-statutory subject matter. During a meeting with
Mikkilineni and his patent attorney, the examiner ex-
plained that he was required to reject the claims as non-
statutory subject matter based on the United States
Patent and Trademark Office’s (“USPTO”) Interim Patent
Subject Matter Eligibility Examination Instructions
(“Interim Guidelines”). 1 The Interim Guidelines provide
that “[p]urely mental processes in which thoughts or
human based actions are ‘changed’ are not considered an
eligible transformation.” USPTO, Interim Examination
Instructions for Evaluating Subject Matter Eligibility
Under 35 U.S.C. § 101 (Aug. 25, 2009), available at

   1    The Interim Guidelines were issued by the
USPTO to aid patent examiners in evaluating subject-
matter eligibility during the time between this Court’s
decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en
banc), and the Supreme Court’s decision in Bilski v.
Kappos, 130 S.Ct. 3218 (2010).
3                                     MIKKILINENI   v. STOLL


http://www.uspto.gov/web/offices/pac/dapp/opla/2009-08-
25_interim_101_instructions.pdf.
     The Interim Guidelines were posted on the USPTO’s
official website with a notice requesting public comment
and indicating a deadline for receipt of comments.
Though not required to do so, the USPTO also published a
request for comments in the Federal Register. See Re-
quest for Comments on Interim Examination Instructions
for Evaluating Patent Subject Matter Eligibility, 74 Fed.
Reg. 47,780 (Sept. 17, 2009) (“Request for Comments”).
The Request for Comments included an explanation that
the Interim Guidelines were interpretive guidance based
on the USPTO’s current understanding of the law, stating
specifically that the “Examination Instructions do not
constituted substantive rule making and hence do not
have the force and effect of law.” Id. The Request for
Comments further advised that “[r]ejections are and will
continue to be based upon the substantive law.” Id.
    Mikkilineni filed a response to the Office Action and,
one day later, filed suit under the Administrative Proce-
dure Act (“APA”) to challenge the USPTO’s Interim
Guidelines, alleging that the USPTO violated 5 U.S.C. §
553(b)–(c) by failing to provide notice and an opportunity
for comment on interim interpretive guidance issued by
the agency. Complaint, Mikkilineni v. Stoll, No. 09-CV-
1412 (E.D. Va. Apr. 30, 2009). The district court granted
the USPTO’s motion to dismiss under Federal Rules of
Civil Procedure 12(b)(1) and (6). We have jurisdiction
pursuant to 28 U.S.C. § 1295(a)(1).
                       DISCUSSION
    We review orders dismissing under Rules 12(b)(1) or
(6) de novo. Boyle v. U.S., 200 F.3d 1369, 1372 (Fed. Cir.
2000). On appeal, Mikkilineni contends that: (1) the
Interim Guidelines are substantive rules improperly
MIKKILINENI   v. STOLL                                   4


promulgated without notice and comment rulemaking,
and (2) the USPTO examiner improperly rejected his
application. We reject both claims.
                             I
    Under § 553 of the APA, certain agency actions re-
quire prior public notice and comment. 5 U.S.C. § 553.
Generally speaking, “substantive” rules require notice
and comment, while “interpretive” rules do not. 5 U.S.C.
§ 553(b)(3)(A); Lincoln v. Vigil, 508 U.S. 182, 195–96
(1993); Animal Legal Defense Fund v. Quigg, 932 F.2d
920, 927 (Fed. Cir. 1991). A rule is “substantive” where it
causes a change in existing law or policy that affects
individual rights and obligations and “interpretive” where
it “merely clarifies or explains existing law or regula-
tions.” Animal Legal Defense Fund, 932 F.2d at 927.
    Mikkilineni argues that the Interim Guidelines are
substantive rules within the meaning of the APA because
they substantively deprived him of his rights by requiring
the Examiner to reject his claims under § 101. This
argument is without merit. The USPTO’s Request for
Comments explicitly states both (1) that the guidelines
are “based on the USPTO’s current understanding of the
law and are believed to be fully consistent with binding
precedent,” and (2) that the guidelines “do not have the
force and effect of law”; thus, “[r]ejections are and will
continue to be based upon substantive law.” 74 Fed. Reg.
at 47,780.
    Our decision in Animal Legal Defense Fund is almost
directly on point. See 932 F.2d at 920. In that case, the
plaintiffs argued that a notice issued by the USPTO in
response to the Supreme Court’s decision in Diamond v.
Chakrabarty, 447 U.S. 303 (1980), was substantive rule-
making and, as a result, must be promulgated via notice
and comment rulemaking. Animal Legal Defense Fund,
5                                       MIKKILINENI   v. STOLL


932 F.2d at 923–24. The notice, which stated “that the
PTO ‘now considers non-naturally occurring, non-human
multicellular organisms, including animals, to be pat-
entable subject matter within the scope of 35 U.S.C. §
101,’” mirrored the Supreme Court’s holding in Diamond.
Id. at 922–923; see also Diamond, 447 U.S. at 309. This
court rejected the plaintiff’s argument, finding that the
USPTO notice was interpretive rather than substantive.
Animal Legal Defense Fund, 932 F.2d at 931.
    Accordingly, we conclude that the Interim Guidelines
are interpretive, rather than substantive, and are thus
exempt from the notice and comment requirements of §
553 of the APA. See Lincoln, 508 U.S. at 195–96; Animal
Legal Defense Fund, 932 F.2d at 927. As a result, the
district court’s dismissal under Rule 12(b)(6) was proper.
                             II
    The district court also correctly held that it lacked ju-
risdiction to review the examiner’s non-final rejection.
Under the APA, final agency action is required before
judicial review is permitted. 5 U.S.C. § 704. As a general
rule, two conditions must be met for agency action to be
considered final under the APA: (1) “the action must mark
the ‘consummation’ of the agency’s decisionmaking proc-
ess—it must not be of a merely tentative or interlocutory
nature”; and (2) “the action must be one by which ‘rights
or obligations have been determined,’ or from which ‘legal
consequences will flow.’” Bennett v. Spear, 520 U.S. 154,
177–78 (1997) (internal citations omitted).
    There has been no final agency action in this case.
The non-final rejection of Mikkilineni’s claims did not
constitute the consummation of the agency’s decision
making process. Mikkilineni’s claims are still pending—
no final rejection has been entered. All prosecution in his
application has been stayed pending the outcome of this
MIKKILINENI   v. STOLL                                     6


litigation. After a non-final rejection, the applicant may
reply to the rejection and “the application or the patent . .
. will be reconsidered and again examined.” 37 C.F.R. §
1.112. When the examiner issues a final rejection Mik-
kilineni may appeal to the Board of Patent Appeals and
Interferences (“Board”). Only after a Board decision
affirming a final rejection is judicial review available.
Additionally, the non-final rejection by the examiner is
not an action from which legal consequences will flow—in
theory, Mikkilineni could still overcome the non-final
rejection and receive a patent. As a result, the district
court’s dismissal under Rule 12(b)(1) was proper.

                         AFFIRMED
