Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices62194. Determine Whether One of OrdinarySkill in the Art Would Have BeenMotivated To Select the ClaimedSpecies or SubgenusIn light of the findings made relatingto the three Graham factors, <strong>Office</strong>personnel should determine whetherone of ordinary skill in the relevant artwould have been motivated to make theclaimed invention as a hole, i.e., toselect the claimed species or subgenusfrom the disclosed prior art genus. 18 Toaddress this key issue, <strong>Office</strong> personnelshould consider all relevant prior artteachings, focusing on the following,where present.a. Consider the Size of the Genus.Consider the size of the prior art genus,bearing in mind that size alone cannotsupport an obviousness rejection. 19There is no absolute correlation betweenthe size of the prior art genus and aconclusion of obviousness. 20 Thus, themere fact that a prior art genus containsa small number of members does notcreate a per se rule of obviousness.Some motivation to select the claimedspecies or subgenus must be taught bythe prior art. 21 However, a genus may beso small that it would anticipate theclaimed species or subgenus. Forexample, it has been held that a prior artgenus containing only 20 compoundsinherently anticipated a claimed specieswithin the genus because ‘‘one skilledin (the) art would * * * envisage eachmember’’ of the genus. 22b. Consider the Express Teachings. Ifthe prior art reference expressly teachesa particular reason to select the claimedspecies or subgenus, <strong>Office</strong> personnelshould point out the express disclosurewhich would have motivated one ofordinary skill in the art to select theclaimed invention. 23c. Consider the Teachings ofStructural Similarity. Consider anyteachings of a ‘‘typical,’’ ‘‘preferred,’’ or‘‘optimum’’ species or subgenus withinthe disclosed genus. If such a species orsubgenus is structurally similar to thatclaimed, its disclosure may motivateone of ordinary skill in the art to choosethe claimed species or subgenus fromthe genus, 24 based on the reasonableexpectation that structurally similarspecies usually have similarproperties. 25 The utility of suchproperties will normally provide somemotivation to make the claimed speciesor subgenus. 26In making an obviousnessdetermination, <strong>Office</strong> personnel shouldconsider the number of variables whichmust be selected or modified, and thenature and significance of thedifferences between the prior art and theclaimed invention. 27 The closer thephysical and chemical similaritiesbetween the claimed species orsubgenus and any exemplary species orsubgenus disclosed in the prior art, thegreater the expectation that the claimedsubject matter will function in anequivalent manner to the genus. 28Similarly, consider any teaching orsuggestion in the reference of apreferred species or subgenus that issignificantly different in structure fromthe claimed species or subgenus. Sucha teaching may weigh against selectingthe claimed species or subgenus andthus against a determination ofobviousness. 29 For example, teachingsof preferred species of a complex naturewithin a disclosed genus may motivatean artisan of ordinary skill to makesimilar complex species and thus teachaway from making simple specieswithin the genus. 30 Concepts used toanalyze the structural similarity ofchemical compounds in other types ofchemical cases are equally useful inanalyzing genus-species cases. 31Generally, some teaching of a structuralsimilarity will be necessary to suggestselection of the claimed species orsubgenus 32d. Consider the Teachings of SimilarProperties or Uses. Consider theproperties and utilities of thestructurally similar prior art species orsubgenus. It is the properties andutilities that provide real worldmotivation for a person of ordinary skillto make species structurally similar tothose in the prior art. 33 Conversely, lackof any known useful properties weighsagainst a finding of motivation to makeor select a species or subgenus. 34However, the prior art need not disclosea newly discovered property in order forthere to be a prima facie case ofobviousness. 35 If the claimed inventionand the structurally similar prior artspecies share a useful property, that willgenerally be sufficient to motivate anartisan of ordinary skill to make theclaimed species. 36 For example, basedon a finding that a tri-orthoester and atetra-orthoester behave similarly incertain chemical reactions, it has beenheld that one of ordinary skill in therelevant art would have been motivatedto select either structure. 37 In fact,similar properties may normally bepresumed when compounds are veryclose in structure. 38 Thus, evidence ofsimilar properties weighs in favor of aconclusion that the claimed inventionwould have been obvious. 39e. Consider the Predictability of theTechnology. Consider the predictabilityof the technology. 40 If the technology isunpredictable, it is less likely thatstructurally similar species will rendera claimed species obvious because itmay not be reasonable to infer that theywould share similar properties. 41However, obviousness does not requireabsolute predictability, only areasonable expectation of success, i.e., areasonable expectation of obtainingsimilar properties. 42f. Consider Any Other Teaching toSupport the Selection of the Species orSubgenus. The categories of relevantteachings enumerated above are thosemost frequently encountered in a genusspeciescase, but they are not exclusive.<strong>Office</strong> personnel should consider thetotality of the evidence in each case. Inunusual cases, there may be otherrelevant teachings sufficient to supportthe selection of the species or subgenusand, therefore, a conclusion ofobviousness.5. Make Express Fact-Findings andDetermine Whether They Support APrima Facie Case of ObviousnessBased on the evidence as a whole, 43<strong>Office</strong> personnel should make expressfact-findings relating to the Grahamfactors, focusing primarily on the priorart teachings discussed above. The factfindingsshould specifically articulatewhat teachings or suggestions in theprior art would have motivated one ofordinary skill in the art to select theclaimed species or subgenus. 4Thereafter, it should be determinedwhether these findings, considered as awhole, support a prima facie case thatthe claimed invention would have beenobvious to one of ordinary skill in therelevant art at the time the inventionwas made.B. Determining Whether RebuttalEvidence Is Sufficient To Overcome thePrima Facie Case of ObviousnessIf a prima facie case of obviousness isestablished, the burden shifts to theapplicant to come forward witharguments and/or evidence to rebut theprima facie case. 45 Rebuttal evidenceand arguments can be presented in thespecification, 46 by counsel, 47 or by wayof an affidavit or declaration under 37CFR 1.132. 48 However, arguments ofcounsel cannot take the place offactually supported objectiveevidence. 49<strong>Office</strong> personnel should consider allrebuttal arguments and evidencepresented by applicants. 50 Rebuttalevidence may include evidence of‘‘secondary consideration,’’ such as‘‘commercial success, long felt butunsolved needs, (and) failure ofothers,’’ 51 evidence that the claimedinvention yields unexpectedlyimproved properties or properties notpresent in the prior art, 52 or evidencethat the claimed invention was copied
6220 Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Noticesby others. 53 It may also includeevidence of the state of the art, the levelof skill in the art, and the beliefs ofthose skilled in the art. 54Consideration of rebuttal evidenceand arguments requires <strong>Office</strong> personnelto weigh the proffered evidence andarguments. <strong>Office</strong> personnel shouldavoid giving evidence no weight, exceptin rare circumstances. 55 However, to beentitled to substantial weight theapplicant should establish a nexusbetween the rebuttal evidence and theclaimed invention, 56 i.e., objectiveevidence of nonobviousness must beattributable to the claimed invention. 57Additionally, the evidence must bereasonably commensurate in scope withthe claimed invention. 58 However, anexemplary showing may be sufficient toestablish a reasonable correlationbetween the showing and the entirescope of the claim, when viewed by askilled artisan. 59 On the other hand,evidence of an unexpected propertymay not be sufficient regardless of thescope of the showing. 60 Accordingly,each case should be evaluatedindividually based on the totality of thecircumstances.<strong>Office</strong> personnel should not evaluaterebuttal evidence for its ‘‘knockdown’’value against the prima facie cases 61 orsummarily dismiss it as not compellingor insufficient. If the evidence isdeemed insufficient to rebut the primafacie case of obviousness, <strong>Office</strong>personnel should specifically set forththe facts and reasoning that justify thisconclusion.III. Reconsider All Evidence andClearly Communicate Findings andConclusionsA determination under 35 U.S.C. 103should rest on all the evidence andshould not be influenced by any earlierconclusion. 62 Thus, once the applicanthas presented rebuttal evidence, <strong>Office</strong>personnel should reconsider any initialobviousness determination in view ofthe entire record. 63 All the proposedrejections and their bases should bereviewed to confirm their correctness.Only then should any rejection beimposed in an <strong>Office</strong> action. The <strong>Office</strong>action should clearly communicate the<strong>Office</strong>’s findings and conclusions,articulating how the conclusions aresupported by the findings.Where applicable, the findings shouldclearly articulate which portions of thereference support any rejection. Explicitfindings on motivation or suggestion toselect the claimed invention should alsobe articulated in order to support a 35U.S.C. 103 ground of rejection. 64Conclusory statements of similarity ormotivation, without any articulatedrationale or evidentiary support, do notconstitute sufficient factual findings.VI. Footnotes1. When evaluating the scope of a claim,every limitation in the claim must beconsidered. E.g., In re Ochiai, 71 F.3d 1565,1572, 37 USPQ2d 1127, 1133 (Fed. Cir.1995). However, the claimed invention maynot be dissected into discrete elements to beanalyzed in isolation, but must be consideredas a whole. E.g., W.L. Gore & Assoc., Inc. v.Garlock, Inc., 721 F.2d 1540, 1548, 220 USPQ303, 309 (Fed. Cir. 1983), cert. denied, 469U.S. 851 (1984); Jones v. Hardy, 727 F.2d1524, 1530, 220 USPQ 1021, 1026 (Fed. Cir.1983) (‘‘treating the advantage as theinvention disregards the statutoryrequirement that the invention be viewed ‘asa whole’ ’’).2. Both claimed and unclaimed aspects ofthe invention should be searched if there isa reasonable expectation that the unclaimedaspects may be later claimed.3. ‘‘The section 103 requirement ofunobviousness is no different in chemicalcases than with respect to other categories ofpatentable inventions.’’ In re Papesch, 315F.2d 381, 385, 137 USPQ 43, 47 (CCPA 1963).4. E.g., In re Dillon, 919 F.2d 688, 692–93,16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (inbanc), cert. denied, 500 U.S. 904 (1991).5. E.g., In re Brouwer, 77 F.3d 422, 425, 37USPQ2d 1663, 1666 (Fed. Cir. 1996); In reOchiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127,1133 (Fed. Cir. 1995); In re Baird, 16 F.3d380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir.1994).6. In re Baird, 16 F.3d 380, 382, 29USPQ2d 1550, 1552 (Fed. Cir. 1994) (‘‘Thefact that a claimed compound may beencompassed by a disclosed generic formuladoes not by itself render that compoundobvious.’’); In re Jones, 958 F.2d 347, 350, 21USPQ2d 1941, 1943 (Fed. Cir. 1992) (FederalCircuit has ‘‘decline[d] to extract from Merck(& Co. v. Biocraft Laboratories Inc., 874 F.2d804, 10 USPQ2d 1843 (Fed. Cir. 1989)) therule that * * * regardless of how broad, adisclosure of a chemical genus rendersobvious any species that happens to fallwithin it.’’). See also In re Deuel, 51 F.3d1552, 1559, 34 USPQ2d 1210, 1215 (Fed. Cir.1995).7. E.g., In re Bell, 991 F.2d 781, 783, 26USPQ2d 1529, 1531 (Fed. Cir. 1993) (‘‘ThePTO bears the burden of establishing a caseof prima facie obviousness.’’); In re Rijckaert,9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956(Fed. Cir. 1993); In re Oetiker, 977 F.2d 1443,1445, 24 USPQ2d 1443, 1444 (Fed. Cir.1992).Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966), requires that to make out a caseof obviousness, one must: (1) Determine thescope and contents of the prior art; (2)ascertain the differences between the priorart and the claims in issue; (3) determine thelevel of skill in the pertinent art; and (4)evaluate any evidence of secondaryconsiderations.8. E.g., Bell, 991 F.2d at 783–84, 26USPQ2d at 1531; Rijckaert, 9 F.3d at 1532,28 USPQ2d at 1956; Oetiker, 977 F.2d at1445, 24 USPQ2d at 1444.9. Id.10. E.g., In re Brouwer, 77 F.3d 422, 425,37 USPQ2d 1663, 1666 (Fed. Cir. 1996)(‘‘[T]he mere possibility that one of the estersor the active methylene group-containingcompounds * * * could be modified orreplaced such that its use would lead to thespecific sulfoalkylated resin recited in claim8 does not make the process recited in claim8 obvious ‘unless the prior art suggested thedesirability of [such a] modification’ orreplacement.’’) (quoting In re Gordon, 733F.2d 900, 902, 221 USPQ 1125, 1127 (Fed.Cir. 1984); In re Vaeck, 947 F.2d 488, 493, 20USPQ2d 1438, 1442 (Fed. Cir. 1991) (‘‘[A]proper analysis under section 103 requires,inter alia, consideration of * * * whether theprior art would have suggested to those ofordinary skill in the art that they shouldmake the claimed composition or device, orcarry out the claimed process.’’).11. The prior art disclosure may beexpress, implicit, or inherent. Regardless ofthe type of disclosure, the prior art mustprovide some motivation to one of ordinaryskill in the art to make the claimed inventionin order to support a conclusion ofobviousness. E.g., Vaeck, 947 F.2d at 493, 20USPQ2d at 1442 (A proper obviousnessanalysis requires consideration of ‘‘whetherthe prior art would also have revealed thatin so making or carrying out (the claimedinvention), those of ordinary skill wouldhave a reasonable expectation of success.’’);In re Dow Chemical Co., 837 F.2d 469, 473,5 USPQ2d 1529, 1531 (Fed. Cir. 1988) (‘‘Theconsistent criterion for determination ofobviousness is whether the prior art wouldhave suggested to one of ordinary skill in theart that this process should be carried outand would have a reasonable likelihood ofsuccess, viewed in the light of the priorart.’’); Hodosh v. Block Drug Co., 786 F.2d1136, 1143 n. 5, 229 USPQ 182, 187 n. 5(Fed. Cir.), cert. denied, 479 U.S. 827 (1986).12. When evidence of secondaryconsiderations such as unexpected results isinitially before the <strong>Office</strong>, for example, in thespecification, that evidence should beconsidered in deciding whether there is aprima facie case of obviousness. Thedetermination as to whether a prima facieexists should be made on the full recordbefore the <strong>Office</strong> at the time of thedetermination.13. Graham v. John Deere, 383 U.S. 1, 17,148 USPQ 459, 467 (1966). Accord, e.g., Inre Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d1671, 1676 (Fed. Cir. 1994).14. E.g., Panduit Corp. v. Dennison Mfg.Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593,1597 (Fed. Cir.) (‘‘Before answering Graham’s‘content’ inquiry, it must be known whethera patent or publication is in the prior artunder 35 U.S.C. § 102.’’), cert. denied, 481U.S. 1052 (1987).15. In re Oetiker, 977 F.2d 1443, 1447, 24USPQ2d 1443, 1445 (Fed. Cir. 1992). Accord,e.g., In re Clay, 966 F.2d 656, 658–59, 23USPQ2d 1058, 1060 (Fed. Cir. 1992).16. In Stratoflex, Inc. v. Aeroquip Corp.,713 F.2d 1530, 1537, 218 USPQ 871, 877(Fed. Cir. 1983), the Court noted that ‘‘thequestion under 35 U.S.C. 103 is not whetherthe differences [between the claimedinvention and the prior art] would have beenobvious’’ but ‘‘whether the claimed invention
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