## United States Court of Appeals for the Federal Circuit

04-1160

STAR FRUITS S.N.C. and INSTITUTE OF EXPERIMENTAL BOTANY, Plaintiffs-Appellants,

v.

UNITED STATES and DEPARTMENT OF COMMERCE, Defendants-Appellees, and PATENT AND TRADEMARK OFFICE and JON DUDAS, Director, Patent and Trademark Office and Under Secretary of Commerce for Intellectual Property, Defendants-Appellees.

Patrick H. Ballew , Stratton Ballew PLLC, of Ya kima, Washington, argued for plaintiffs-appellants. Stephen Walsh , Associate Solicitor, United Stat es Patent and Trademark Office, argued for defendants-appellees. With him on the brief were John M. Whealan , Solicitor, and Linda Moncys Isacson , Associate Solicitor.

Appealed from: United States District Court for the Eastern District of Virginia Judge Leonie M. Brinkema

## United States Court of Appeals for the Federal Circuit

04-1160 STAR FRUITS S.N.C. and INSTITUTE OF EXPERIMENTAL BOTANY, Plaintiffs-Appellants,

v. UNITED STATES and DEPARTMENT OF COMMERCE, Defendants-Appellees, and PATENT AND TRADEMARK OFFICE and JON DUDAS, Director, Pat ent and Trademark Office and

Under Secretary of Commerc e for Intellectual Property, Defendants-Appellees.

______ ____________________ DECIDED: January 3, 2005

______ ____________________ Before NEWMAN, CLEVENGER and DYK, Circuit Judges. Opinion for the court filed by Circuit Judge CLEVENGER. Dissenting opinion filed by Circuit Judge NEWMAN. CLEVENGER, Circuit Judge

.

Star Fruits S.N.C. and Inst itute of Experimental Botany ("Star Fruits") appeal the decision of the United States District Court for the East ern District of Virginia denying Star Fruits's motion for su mmary judgment and granting summa ry judgment in favor of the United States. Star Fruits S.N.C. v. United States , 280 F. Supp. 2d 512 (E.D. Va. 2003). Because the United States Patent and Trademark Office ("the Office") did notact unlawf u lly when it deemed St ar Fruits's patent applic at ion abando ned for failing to respond to a Requirement For Information under 37 C.F.R. § 1. 105, we affirm the judgment of the district court.
I The facts of this case are straightforw ard. Star Fruits filed U.S. Patent Application No. 09/557,043, directed to a vari ety of peach tree. A subsequent Office Action inc l uded a "Requirement For Information Under 37 C.F.R. 1.105." S pecifica lly, the Office sought "any information avail able regar ding the sale or other public distribution of the claimed plant variety anywhere in the world" and "copies of the application, published proposed denomination and publis hed Breeder 's Right grant." The Office further informed Star Fruits th at to the ex tent Star Fruits did not have or could not readily obtain the required informati on, a st atement to that effect would " b e accepted as a complete response to t he requirement for that item." Star Fruits declined to prov ide the required information on the grounds that it wa s "not materi al to patentability of the new va riety." The Respons e accompanying Sta r Fruits's refusal to provide th e required information did not stat e that Star Fruits did not have or c o uld not readily obtain the information. Instead, the Res ponse made clear that Star Fruits anticipated a reje ction of its application under 35 U.S.C. § 102 if it complied with the Office's requirement, th at it view ed the prospective rejection based on t he requested information as contrary to law, and that it refused to pr ovide the information because it sought to prevent the Office from making the rejection. The Office viewed Star Fruits's refusal to provide the required information as a "deliberate omission, not a bona fide attempt at a complete response," and issued a

04-1160 2Notice of Abandonment. Purs uant to 37 C. F.R. § 1.181, Star Fruits petitioned the Director to require the Examiner to accept St ar Fruits's Response as complete. The Director denied the petition, stating: The threshold for requiring infor m ation from applicants under 37 CF R 1.105 is that the informat ion required is reasonably necessary to treat a matter in an application. The matte r may or may not be related to patentability. The matter here is a m a tter of patentability and the information required is necessary for the examiner to make a reasoned judgment under 35 U.S.C. 102(b) of patentability. Applicant's arguments have not s hown, in rebuttal, that t he information reques ted to be provided is unneces sary or unreasonable. In c ontras t, the exam iner has shown by appropriate arguments that the information requested is necessar y under ex parte Thomson , 24 USPQ2d, 1618. (J.A. at 98.) The Director reset the time period for Star Fruits to respond to the Requirement For Information to three months. Star Fruits requested reconsideration. The request was granted, the request for re lief from the Requirement For Information was again denied, and the applic ati on was deemed abandoned. Star Fruits brought suit in the dist rict court. It claimed t hat the Office abused its discretion when it denied Star Fruits's petition challe nging the Requir ement For Information because, as a matte r of law according to Star Fruits, the information the Office sou ght could not be used to re ject Star Fruits's applicat ion. The district court disagreed, concluding that "such info rmation as may be reasonably necessary to properly examine or treat the matter," 37 C.F. R. § 1.105(a)(1), includes information that may not be directly us ed to reje ct an ass e rtion of pate n t ability. Star Fruits , 280 F. Supp. 2d at 515-16. It further held that a section 1.181 petition is "t he exclusive administrative check on the discretion of i ndiv i dual patent examiners befor e a determination has been made on the merits of an appl ication," and when the Dir ector concluded that the requirement was proper, "Star Fruits had no choice but to comply." Id. at 516.

04-1160 3Accordingly, the distri ct court hel d that by refusing to provide the required information, Star Fruits abandoned its application. Id. at 517. II Star Fruits appeals. Becaus e this claim, brought purs uant to the Administrative Procedure Act ("APA"), see 5 U.S.C. §§ 702-706 (2000), invo lves the Director's duties "[i]n the course of examining or treating a m a tter in [an application] . . . in a patent, or in a reexamination proceeding," 37 C.F.R. § 105(a)(1), it ra ises a substantial question under the patent laws, and, accor d ingly, we have jurisdiction under 28 U.S.C. § 1338( a ) and 28 U.S.C. § 1295(a)(1) (2000). See Helfgott & Kar a s, P.C. v. Dickens on , 209 F.3d 1328, 1333-35 (Fed. C i r. 2000). We review the district court's grant of summary judgment without deference, reapplying the same standard as the distri ct court. See Conroy v. Reebok Int'l, Ltd. , 14 F.3d 1570, 1575 ( F ed. Cir. 1994). Under the APA, courts " hold unlawful and set aside agency action . . . found to be . . . arbitr ary, capri c ious, an abuse of dis c retion, or otherwise not in acc o rdance wit h law." 5 U.S.C. § 706(2); Arnold P'ship v. Dudas , 362 F.3d 1338, 1340 (Fed. Cir. 2004). An abus e of discretion occurs where the decision is based on an erroneous interpretation of the law, on factual findings that are not suppor ted by substantial evidence, or represents an u n reas onable j udgment in weighing relevant factors. 362 F.3d at 1340. III Star Fruits's contention on appeal is that the Directo r abused his discretion when he required complianc e with the Requirement For Informa tion bec ause it was based on an erroneous interpretation of law. In particu lar, Star Fruits cont ends that the language,

04-1160 4"such information as may be reasonably nece ssary to properly examine or treat the matter," from section 1.105 may not include "any information availa ble regarding the sale or other public distribution of the clai m ed plant va riety anywher e in the world" and "copies of the applic ation, publis hed proposed denom inati on and publis hed Breeder's Right grant." This is s o , according to Star Fr uits, because the duty of cand or embodied in 3 7 C.F. R. § 1.56, whic h re quires a p p lic ants to disclos e informa tion material to patentability, controls section 1. 105 requirements. The effect of this, again according t o Star Fruits, is that an applicant need not comply with any section 1.105 requirement that seeks information that is not ma terial to p a t entability. Here, Sta r Fruits e x tends this logic by equating the concept of "material to patentability" wit h inf o rmation that directly supports a rejection. Moreover, Star Fruits asserts that the applic ant, not the examiner, decides what informati on is material to patent ability under section 1.56. Thus, in Star Fruits's view, the Office cannot require information unless the product of th e requirement will result in a rejection and were the Office to require any other information, section 1.56 affords Star Fruits the power to refuse the requirement. We respond first, in detail, to Star Fruits's arguments.
A i Under 37 C.F.R. § 1.105 the Office can requ ire information that does not directly support a rejection. An agency ' s interpretati on of its own regulations is entitled to substantial deference and will be accepted unless it is plainl y erroneous or inconsistent with the regulation. See Eli Lilly & Co. v. Bd. of Regents of the Univ. of Wa. , 334 F.3d 1264, 1266 (Fed. Cir . 2003). Here, the Office considered infor m ation concerning any

04-1160 5sale or public distribution of the claim ed invention and any inf o rmation concerning Breeder's Rights applications or grants as within the author ized scope of a Requirement For Information under section 1.105. This interpretation is not plainly erroneous or inconsistent wit h the regulat i on. Congress has delegated to the Office the rulemaking power to "establish r e gulations, not inconsistent with law, which—(A) shall govern the cond uct of proceedings in the Office." 35 U.S.C. § 2(b)(2) (20 00) (forme rly at 35 U.S.C. § 6(a) (1988), see Merck & Co. v. Kessler , 80 F.3d 1543, 1549-50 (Fed. Cir. 1996)); Stevens v. Tamai , 366 F.3d 1325, 1333 (Fed. Cir. 2004). Section 1.105 stems from an initiative entitled Changes to Implement the Patent Bus i ness Goals . Through notic e and com m ent rulemaking the Office made ex plicit t he inherent authority of Office e m ployees to require information from an applicant. The goal is to "encourage" employees to use that power to "perform the best quality examination pos sible." 65 Fed. Reg. 54,604, at 54,633 (September 8, 2000) (to be codified at 37 C.F. R. pts. 1, 3, 5, 10); see also 64 Fed. Reg. 53,772 (proposed October 4, 1999); 63 Fed. Reg. 53,498 (proposed October 5, 1998). The final rule permits that "the exam iner or other Office employee may require the submission . . . of such information as may be reasonably necessary to properly examine or treat the ma tter." 37 C.F.R. 1.105(a )(1) (emphasis added). We think it clear that "such information as may be reasonably necessary to properly examine or treat the matter," 37 C.F.R. 1.105(a)(1), contemplates information relevant to examination eit her procedurally or substantiv ely. It includes a zone of information beyond that defined by section 1. 56 as material to patentability, and beyond

04-1160 6that which is directly useful to support a re jection or conclusively decide t he issue of patentability. Several observatio n s militat e in favor of this conclus i on. First, under the current regulations an a pplic ant has an affirmative duty to disclos e information material to patentability. See 37 C.F.R. § 1.56. Because an applicant already has a duty to disclose t h is information, it makes no sense for the Office to promulgate a rule empowering it to "require the submission" of information the applicant is required to submit in the first instance. Second, s e ction 1.105 ident ifies the required infor m at ion as that information "reasonably necessary to properly examine or treat the matter" instead of that information "material to patentabi lity." Under ordinary principles of interpretation, the choice of different language indicates a different intended meaning. Third, the plain language of the regulation contem plates requirements for information that go beyond information requir ed by section 1.56. For example, " any non-patent literature . . . by any of the invent ors, that rel a tes to the claimed inv e ntion [,]" 37 C.F.R. § 1.105(a)(1)(iii) (emphasis added), could inc l u d e sales brochures, catalogues, or PBR applic ations or grants. "[ A]ny use of the claimed invention known to any of the inventors at the ti me the applic ation was filed not withstanding the date of the use," id. § 1.105(a)(1)(vii) (emphasis added), could refer to uses that would not affect patentability at all. Li kewise, inf o rmation directed to w hether a search was conducted and what was searched, id § 1.105(a)(1)(ii), is not necessar ily required by s e ction 1.56. Other requirements for information are also for e seeable under the "reasonably necessary to properly examine or treat the matter" standard. For instance, it might be reasonably necessary for the Office to require an explanation of tec hnical material in a

04-1160 7publication, such as one of the inventor' s publications, or require the applicant's comments on a recent Federal Cir cuit opinion and how that opini on affects examination. See, e.g. , 65 Fed. Reg. at 54,634. Although this informa tion improves the quality a n d efficiency of examination it is not necessarily information that an app lic ant is required to provide under section 1.56. 1 In sum, w e think that the Offi ce's interpretation of 37 C.F.R. § 1.105 conforms to the pl ain language of the regulation. ii The duty of candor embodied in 37 C.F.R. § 1.56 does not give the applicant the power to refuse a Requirement F o r Informati on under s e ction 1.105. 2 Neither regulation states that responses to R equirements For Information can be limit ed, at the applic ant's discretion, to whatever the applic ant believes it might have been affi rmatively required to submit under section 1.56. Moreover, we think the l anguage, "Office . . . may re quire the submission . . . of . . . information", 37 C.F.R. § 1.105(a)(1), very expressly st ates that the Office, not the applicant, controls the scope of the requirement. Because the scope of information "reasonably necessar y to properly examine or treat the matter" is broader than that information the applic ant is duty-bound to provi de under section 1.56, we are convinced

1 The dissent also cites section 2001. 05 of the Manual of Patent Examining Procedure, which states: "If the i n formation is not material, there is no duty to disclos e it to the Offic e ." This is merely cumulative with Star Fruits's argum ent that section 1.56 limits section 1.105, since MPEP ' 2001.05 is entitled "Mater iality Under 37 C.F.R. 1.56(b)."

2 Of course the duty of candor and the requirement that an applicant behave equitably in its trans actions with the Office still applies to responses t o Requirements For Information.

04-1160 8that the Office can require the ap plica n t to s ubmit such in formation when it is known or readily available. B Star Fruits's argument fails to come to gr ips with the real issue in this case, whic h is whether the Office can use se ction 1.105 to compel disclos ure of information that the examiner deems pertinent to pat entability when the applicant has a contrary view of the applicable law. We answer this question in the affirmati ve. The Office is clearly entitled to use sect ion 1.105 to seek information that may support a r e jection. J u st as the applicant produces inf o rmation it deems pe rtinent to patentability under section 1.56, the exami ner is free to request information under section 1.105 that the exami ner deems pertinent to the issue of patentability. In this case, the dispute over whet her Star Fruits should be compelled to answer the examiner’s Requirement For Informati on under section 1. 105 boils down t o a disagreem ent between Star Fr ui ts and the examiner as to t he signific ance of the information sought to t he ultimate question of whether Star Fruits’s application disclos es patentable subject matter. The Director is charged with the duty of deciding whether a patent should issue from an application. To perfo rm that duty, the law must be applied to the facts at hand in a n y a p p licatio n. T hat the person charged with enfor cement of the law, here an examiner, may sometimes disagree with the applic ant on the theory or scope of the law to be applied is hardly surpris i ng. So long as the request from the examiner for information is not arbitrary or capricious , the applic ant cannot impede the examiner’s performance of his duty by refusing to comp ly with an information requirement whic h

04-1160 9proceeds f r om the examiner’s view of the scope of t he law to be ap plied to the application at hand. To allow such interference would have the effect of forcing the Office to make patentability det erminations on insufficient fa cts and information. Such conduct inefficiently s h ifts the burden of obt ai ning information that th e applic ant is in the best position to most cheaply provide ont o the shoulders of the Office and risks the systemic inefficiencies that a ttend the issue of invalid patents. Examination under such circumstances is neither fair and equi table to the public nor efficient.
IV Star Fruits alternatively ar gues that the information sought is not relevant to the examinatio n process and that the request was therefore im proper. APA challenges in cases like this are not properly directed to prospective patentability determinations. A claim that the Office is abusing its discret ion in seeking informa tion from an applicant because the Office might (or wil l) use that inform ation to enter a rejection is a preemptive challenge to the Offic e 's patent ability deter mination. Assuming the Office intended to enter a reject ion under 35 U.S.C. § 102( b), the correctness vel non of that rejection is not properly challenged by St ar Fruits withholding information from the Office. Instead, Star Fruits must await a rejection under section 102(b) and then litigat e the propriety of that rejecti on before the proper forum for such a complaint, in the first instance, the Board of Pat ent Appeals and Interferences , not the distric t court. See
35 U.S.C. § 134(a) (2000). Preempting the Office's decision-making by refusing reasonable requirements for information is not a course calculat ed to achieve a timely and equitable determination of whether a patent should be granted.

04-1160 10In the matter at hand, the Examiner's Requirement For In formation was not unreasonable and was within the scope of sect ion 1.105. Accordingly, there is no abuse of discretion or ar bitrary or capricious conduct in the Director's decision to refuse to grant Star Fruits's pet ition under 37 C.F.R. § 1.181 either initially or on reconsider ation. Star Fr uits abandoned its applic ation. As noted above, the distri ct court viewed t he secti on 1.181 petition process as the "exclusive administrative check" on the discretion of exam iners to seek i n formation from applicants under section 1. 105. The district court fear ed finding itself in t he position of a "super patent ex aminer" were it called upon to second-guess the actua l examiner by deciding whether the required information coul d support a section 102(b) bar to patentability. 280 F. Supp. 2d at 516. To the extent t he district court deemed itself powerless to review the final action of the Office deeming Star Fr uits’s application as abandoned, it erred. Whether information sought by an exami ner under sect ion 1.105 c ould or would lead to a rejection of the applic ation on it s merits does not, for the reasons we hav e expressed, define the limits of the infor m ation that la wfully may be s ought by an examiner. So long as there is some legitim a te reason for seeking the information under section 1. 105, the applic ant has a duty to respond. If the examiner deems the information sought pertinent to the legal inquiry the examiner must c onduct, the fact that the examiner's theory is inc o rrect is no gr ound on which the a pplic ant may refuse to comply wit h a request for information. The Office is authorized under section 1.105 t o require any information that is eit her releva nt to patentability under any nonfrivilous legal theory, or is reasonably calculated to lead to such relevant information.

04-1160 11If the Director decides , on challenge under se ction 1.181, that a requirement for information is proper, the applic a n t may ch alle nge tha t decision under the APA. The scope of APA review is not, as the district cour t feared, to test the examin er’s theory of the case or the examiner’s findin g s of fact . The district court, on APA revie w , does no t enmesh its e lf in the decision-making process of the examiner. Its function, instead, is simply to guard against the possi bility of arbitrary or capricious behavior by examiners in seeking information. Given the review process, first by the examiner and then by th e Director, eac h receiving argument from the applicant, we th ink it unlikely that many requirements for information will be unreasonable or beyond the scope of section 1.105. However, without mentioning specifics, we imagine t hat there may be cases where the Office might abus e its discretion or be have arbitrarily and c apricious ly in connec tion with a requirement for information. F o r that reas on, this decision should not be read as affirming a hold i ng tha t no APA claim is po ssible after the Director's action.
V Because t he Requirement For Informati on was within the scope of 37 C.F.R. § 1.105 and not unreasonable, the judgment of the district court is affirmed.

AFFIRMED

04-1160 12

## United States Court of Appeals for the Federal Circuit

04-1160

STAR FRUITS S.N.C. and INSTITUTE OF EXPERIMENTAL BOTANY, Plaintiffs-Appellants,

v. UNITED STATES and DEPARTMENT OF COMMERCE, Defendants-Appellees, and PATENT AND TRADEMARK OFFICE and JON DUDAS, Director, Patent and Trademark Office and Under Secretary of Commerce for Intellectual Property, Defendants-Appellees.

NEWMAN, Circuit Judge , dissenting.

I respectfully dissent. Star Fruits challenges the PTO's change in law and practice, whereby in 2001 the agency decided to hold that fo reign sale or use of a plant that has foreign Breeder's Rights registra tion may bar United States patent ability of that plant. The examiner informed Star Fruits that its United States applicati on was subject to rejection on this ground. Star Fruits c hallenged that position by declining to provide the PTO with foreign sales and use information, whereupon t he examiner refused to continue the examination and declared the app lication abandoned. Star Fruits filed a petition to the Director, the only available path of review of the examiner's action. The Director upheld the04-1160 2 PTO's view of the law. Star Fruits then appealed to the district court under the Administrative Procedure Act, arguing that th e agency's action was an improper procedure and not in accordance with law. The district court held that it could not review internal examination practices, and dismissed the appeal. My colleagues state t hat they do not agree with the ground of the district court's dismissal, but instead of remanding to the distri ct court they have themselves decided the appeal, on grounds not distinguishable from that of the district court. Thus this court holds that the examination demand must be complied with, and do es not mention the issue of law that underlies the dispute: the issue of whet her foreign sales and use are relevant to patentability in the United States. Star Fruits extens ively argued this issue in the PTO, and this is the issue that was presented to the district court, Star Fruits stating that the PTO's ruling is contrary to statute: 35 U.S.C. §102. A person shall be entitled to a patent unless -- * * * (b) the invention was patent ed or described in a printed publication in this or a foreign country or in public use or on sale in this country , more than one year prior to the date of the application for patent in the United States, . . . (Emphasis added.) Star Fruits cites Gandy v. Main Belting Co. , 143 U.S. 587, 593 (1892) (foreign sales do not bar patentability) and In re LeGrice , 301 F.2d 929, 935 (CCPA 1962) ("if section 102(b) was to be giv en a different interpretation as to plant patents, it should have been expressly qualified by Congress so that descriptions of plants in printed publications would have been judged by different standards than those so long recognized by leading text writers and the courts"). Thus Star Fruits states that the PTO's decision is contrary to statute and precedent. Star Fr uits also cited the PTO's regulation for examination, which states that:04-1160 3 37 C.F.R. §1.105 Requirements for information. (a)(1) . . . the examiner or other Office employee may require the submission . . . of such information as may be reasonably necessary to properly examine or treat the matter, . . . (Emphasis added.) For materiality, in additi on to 35 U.S.C. §102 Star Fruits cited the Manual of Patent Ex amination Procedure: MPEP 2001.05 . . . If the information is not material, there is no duty to disclose it to the Office. Star Fruits argues that the demanded information of foreign sales and distribution was not "reasonably necessary," for it wa s not "material" to patentab ility. The statute is not mentioned by the panel majority, who simply hold that information must be provided unless the demand is "arbitrary or capricious." T he APA criterion of "contra ry to law" is not mentioned. Despite its broad power to grant or deny patents, the Patent and Trademark Office does not have the responsibility, or the authority, to depart from the law, or to make or change the policy embodied in the la w, or to reinterpret the statute in a way that departs from congressional intention or judicial in terpretation. Judicial review under the Administrative Procedure Act serves to test agency compliance with statute and precedent. An agency change of law, particularly a c hange that was not subj ected to notice-andcomment rulemaking before its implementation, is not i mmune from APA review. My colleagues' rule that the patent applicant's only recourse is to comply with the request for information and undergo full examination to final rejection, with appeal available only through the PTO Board of Appeals, bypasse s and forecloses APA procedures. When an agency unilaterally makes a majo r and far-reaching change in law, the entire administrative04-1160 4 process need not be forced to pr oceed on the incorrect law, a process that may consume years, in order to challenge the change in la w. I know of no reason for denying to the invention community the full scope of APA procedur es, now that the Court has confirmed in Dickinson v. Zurko , 527 U.S. 150 (1999), that the APA applie s to the Patent and Trademark Office. The question of law was decided by the PTO Director on Star Fruits' petition, and was properly taken to the district court for substantive review. The new rule and examination practice adopt ed by the PTO is at least facially inconsistent with statute and precedent. It is a si gnificant change in long-standing practice. This change was not subjected to notice-and-co mment rulemaking, but simply to internal arrogation. In such a context, judicial revi ew protects the rights affected by the agency action. See , e.g. , American Power & Light Co. v. SEC , 329 U.S. 90, 10 5 (1946) ("Private rights are protected by access to the courts to te st the application of the policy in the light of these legislative declarations."). The Admi nistrative Procedure Act implements this obligation. Adequate access to the courts, to test conspicuous changes in law and policy initiated by the agency, is fundam ental to the administrative stat e. When a case of "first impression" arises, as is here acknowledged, the agency has a "duty to explain its departure from prior norms." Atchison, Topeka & Santa Fe Ry . Co. v. Wichita Board of Trade , 412 U.S. 800, 808 (1973). The record does not show that the PT O met that duty. See 5 U.S.C. §553 (describing procedures to be followed in administrative rule-making). The judicial duty is both to review agency depar tures from substantive law, and to assure that appropriate procedur es are followed. See Abbott Labs. v. Gardner , 387 U.S. 136, 154 (1967) ("Where the legal issue pr esented is fit for judicial resolution, and where a regulation04-1160 5 requires an immediate and significant change in t he plaintiffs' conduct of their affairs with serious penalties attached to noncompliance, acce ss to the courts under the Administrative Procedure Act and the Declaratory Judgment Act must be permitted, absent a statutory bar or some other unusual circumstance . . ."). Judicial review necessarily includes decidi ng whether the agency's theory of the law is correct. See Citizens to Preserve Over ton Park, Inc. v. Volpe , 401 U.S. 402, 413-14 (1971) ("In all cases agency action must be se t aside if the action was . . . 'not in accordance with law' or if the action failed to meet statutory, procedural, or constitutional requirements"); see also FCC v. NextWave Pers. Communications, Inc. , 537 U.S. 293, 300 (2003) ("The Administrative Procedure Act requi res federal courts to set aside federal agency action that is 'not in accordance with law,' 5 U.S.C. §706(2)(A) -- which means, of course, any law, and not merely those laws that the agency itse lf is charged with administering."); Bowen v. Massachusetts , 487 U.S. 879, 911 (1988) ("It seems perfectly clear that, as 'the reviewing court,' the Distr ict Court had the authority to 'hold unlawful and set aside agency action' that it found to be ' not in accordance with law.'"). The panel majority dilutes this safeguard by holding that j udicial review is available in this case only for PTO Board of Appeals decisions. The question of law that underlies this appeal was recently before this court in a copending case, reported at In re Elsner , 381 F.3d 1125 (Fed. Cir. 2004) (rehearing en banc denied Nov. 23, 2004). Although that decis ion remanded the case to the PTO for further development, it accepted the principle that foreign sales and foreign knowledge may be relevant to patentability in the United States. That case, recognized all around as of "first impression," decided the i ssue of substantive law that under lies Star Fruits' petition.04-1160 6 That should have mooted this appeal. In stead, the panel majority has expounded on various aspects of judicial review, unnecessar ily and generally inaptly. For example, it is incorrect to hold that information can be demanded even if it cannot lead to a rejection on the merits. The PTO nowhere goes that far; the PTO makes clear it s position that the foreign sales information can i ndeed lead to a rejection on the merits. That is why the district court erred in refusing to consider th is question of law, and why this panel similarly errs. The court's validation of the PTO' s right to demand "sales brochures" and other hypothetical information -- such as an applicant's comments on a Federal Circuit decision -- is irrelevant and impertinent. Thus my colleagues err in limiting their review to whether the PTO action was "arbitrary or capricious," for the APA also requi res review to determine whether the action is in "accordance with law." §706(2)(A). It is inco rrect to hold that the applicant must yield to "the examiner's view of the sc ope of the law to be applied." Ma j. op. at 9. That is a misperception of the criteria for judicial review under the APA. This is not examiner discretion; it is a major change of law, a change of economic importance and high controversy. In the administrative stat e, vigilance is required to balance authority and responsibility among the branches of governm ent. The pragmatism of delegation to administrative agencies of complex procedures, is balanced against the responsibility of the courts to assure compliance with law. See INS v. Chadha , 462 U.S. 919, 953 n.16 (1983) (while administrative agencies "implement, interp ret, or prescribe law or policy," the courts "'ascertain whether the will of Congress has been obeyed,' and can enforce adherence to statutory standards") (quoting Yakus v. United States , 321 U.S. 414, 425 (1944) and citing04-1160 7 Youngstown Sheet & Tube Co. v. Sawyer , 343 U.S. 579, 585 (1952)). On this appeal under the Administrative Procedure Act the panel majority neither remands to the district court, nor explores the legal and policy-laden issue that is presented. I respectfully dissent.