federal register - U.S. Government Printing Office

6218 Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / NoticesDated: February 5, 1997.Bruce A. Lehman,Assistant Secretary of Commerce andCommissioner of Patents and Trademarks.I. Interim Guidelines for theExamination of Claims Directed toSpecies of Chemical CompositionsBased Upon a Single Prior ArtReferenceThese ‘‘Genus-Species Guidelines’’are to assist Office personnel in theexamination of applications whichcontain claims to species or a subgenusof chemical compositions forcompliance with 35 U.S.C. 103 basedupon a single prior art reference whichdiscloses a genus encompassing theclaimed species or subgenus but doesnot expressly disclose the particularclaimed species or subgenus. Officepersonnel should attempt to findadditional prior art to show that thedifferences between the prior artprimary reference and the claimedinvention as a whole would have beenobvious. Where such additional prior artis not found, Office personnel shouldfollow these guidelines to determinewhether a single reference 35 U.S.C. 103rejection would be appropriate. Theguidelines are based on the Office’scurrent understanding of the law andare believed to be fully consistent withbinding precedent of the SupremeCourt, the Federal Circuit, and theFederal Circuit’s predecessor courts.The analysis of the guidelines beginsat the point during examination after asingle prior art reference is founddisclosing a genus encompassing theclaimed species or subgenus. Beforereaching this point, Office personnelshould follow normal examinationprocedures. Accordingly, Officepersonnel should first analyze theclaims as a whole in light of andconsistent with the written description,considering all claim limitations. 1 Next,Office personnel should conduct athorough search of the prior art andidentify all relevant references. 2 If themost relevant prior art consists of asingle prior art reference disclosing agenus encompassing the claimedspecies or subgenus, Office personnelshould follow the guidelines set forthherein.These guidelines do not constitutesubstantive rulemaking and hence donot have the force and effect of law.Rather, they are to assist Officepersonnel in analyzing claimed subjectmatter for compliance with substantivelaw. Thus, rejections must be basedupon the substantive law, and it is theserejections which are appealable, not anyfailure by Office personnel to followthese guidelines.Office personnel are to rely on theseguidelines in the event of anyinconsistent treatment of issues betweenthese guidelines and any earlierprovided guidance from the Office.II. Determine Whether the ClaimedSpecies or Subgenus Would Have BeenObvious to One of Ordinary Skill in thePertinent Art at the Time the InventionWas MadeThe patentability of a claim to aspecific compound or subgenusembraced by a prior art genus should beanalyzed no differently than any otherclaim for purposes of 35 U.S.C. 103. 3 Adetermination of patentability under 35U.S.C. 103 should be made upon thefacts of the particular case in view of thetotality of the circumstances. 4 Use of perse rules by Office personnel is improperfor determining whether claimed subjectmatter would have been obvious under35 U.S.C. 103. 5 The fact that a claimedspecies or subgenus is encompassed bya prior art genus is not sufficient byitself to establish a prima facie case ofobviousness. 6A proper obviousness analysisinvolves a three-step process. First,Office personnel should establish aprima facie case of unpatentabilityconsidering the factors set out by theSupreme Court in Graham v. JohnDeere. 7 If a prima facie case isestablished, the burden shifts toapplicant to come forward with rebuttalevidence or argument to overcome theprima facie case. 8Finally, Office personnel shouldevaluate the totality of the facts and allof the evidence to determine whetherthey still support a conclusion that theclaimed invention would have beenobvious to one of ordinary skill in theart at the time the invention was made. 9A. Establishing a Prima Facie Case ofObviousnessTo establish a prima facie case ofobviousness in a genus-species chemicalcomposition situation, as in any other35 U.S.C. 103 case, it is essential thatOffice personnel find some motivationor suggestion to make the claimedinvention in light of the prior artteachings. 10 In order to find suchmotivation or suggestion there shouldbe a reasonable likelihood that theclaimed invention would have theproperties disclosed by the prior artteachings. 11 These disclosed findingsshould be made with a completeunderstanding of the first three‘‘Graham factors.’’ 12 Thus, Officepersonnel should (1) determine the‘‘scope and content of the prior art’’; (2)ascertain the ‘‘differences between theprior art and the claims at issue’’; and(3) determine ‘‘the level of ordinary skillin the pertinent art.’’ 131. Determine the Scope and Content ofthe Prior ArtAs an initial matter, Office personnelshould determine the scope and contentof the relevant prior art. Each referencemust qualify as prior art under 35 U.S.C.102, 14 and should be in the field ofapplicant’s endeavor, or be reasonablypertinent to the particular problem withwhich the inventor was concerned. 15In the case of a prior art referencedisclosing a genus, Office personnelshould make findings as to (1) thestructure of the disclosed prior art genusand that of any expressly describedspecies or subgenus within the genus;(2) any physical or chemical propertiesand utilities disclosed for the genus, aswell as any suggested limitations on theusefulness of the genus, and anyproblems alleged to be addressed by thegenus; (3) the predictability of thetechnology; and (4) the number ofspecies encompassed by the genustaking into consideration all of thevariables possible.2. Ascertain the Differences Between thePrior Art Genus and the ClaimedSpecies or SubgenusOnce a relevant prior art genus isidentified, Office personnel shouldcompare it to the claimed species orsubgenus to determine the differences.Through this comparison, the closestdisclosed species or subgenus in theprior art reference should be identifiedand compared to that claimed. Officepersonnel should make explicit findingson the similarities and differencesbetween the closest prior art referenceand the claimed species or subgenusincluding findings relating to similarityof structure, chemical properties andutilities. 163. Determine the Level of Skill in theArtOffice personnel should evaluate theprior art from the standpoint of thehypothetical person having ordinaryskill in the art at the time the claimedinvention was made. 17 In most cases,the only facts of record pertaining to thelevel of skill in the art will be foundwithin the prior art reference. However,any additional evidence presented byapplicant should be evaluated.