NOTE: This disposition is nonprecedential 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 Alexandria, 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 decision 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). Mikkilineni 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 brainneurons into a different[]physical state and produce 

melatonin and serotonin . . . without the use of drugs.” 

Appellee’s App. A64–65. Mikkilineni’s claims were rejected 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 explained that he was required to reject the claims as nonstatutory 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 subjectmatter 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 Request 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 Procedure 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-CV1412 (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 require 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 regulations.” 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 rulemaking 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 patentable 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 jurisdiction 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 process—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 Mikkilineni 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