Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices6221as a whole would have been obvious.’’(emphasis in original).17. See, Ryko Manufacturing Co. v. Nu-StarInc., 950 F.2d 714, 718, 21 USPQ2d 1053,1057 (Fed. Cir. 1991) (‘‘The importance ofresolving the level of ordinary skill in the artlies in the necessity of maintainingobjectivity in the obviousness inquiry.’’);Uniroyal Inc. v. Rudkin-Wiley Corp., 837F.2d 1044, 1050, 5 USPQ2D 1434, 1438 (Fed.Cir.), cert. denied, 488 U.S. 825 (1988)(evidence must be viewed from position ofordinary skill, not of an expert).18. E.g., Ochiai, 71 F.3d at 1569–70, 37USPQ2d at 1131; Deuel, 51 F.3d at 1557, 34USPQ2d at 1214 (‘‘[A] prima facie case ofunpatentability requires that the teachings ofthe prior art suggest the claimed compoundsto a person of ordinary skill in the art.’’(emphasis in original)); Jones, 958 F.2d at351, 21 USPQ2d at 1943–44 (Fed. Cir. 1992);Dillon, 919 F.2d at 692, 16 USPQ2d at 1901;In re Lalu, 747 F.2d 703, 705, 223 USPQ1257, 1258 (Fed. Cir. 1984) (‘‘The prior artmust provide one of ordinary skill in the artthe motivation to make the proposedmolecular modifications needed to arrive atthe claimed compound.’’). See also In reKemps, 97 F.3d 1427, 1430, 40 USPQ2d1309, 1311 (Fed. Cir. 1996) (discussingmotivation to combine).19. See, e.g., Baird, 16 F.3d at 383, 29USPQ2d at 1552 (observing that ‘‘it is not themere number of compounds in this limitedclass which is significant here but, rather, thetotal circumstances involved’’).20. Id.21. See, e.g., Deuel, 51 F.3d at 1558–59, 34USPQ2d at 1215 (‘‘No particular one of theseDNAs can be obvious unless there issomething in the prior art to lead to theparticular DNA and indicate that it should beprepared.’’); Baird, 16 F.3d at 382–83, 29USPQ2d at 1552; Bell, 991 F.2d at 784, 26USPQ2d at 1531 (‘‘Absent anything in thecited prior art suggesting which of the 10 36possible sequences suggested byRinderknecht corresponds to the IGF gene,the PTO has not met its burden ofestablishing that the prior art would havesuggested the claimed sequences.’’).22. In re Petering, 301 F.2d 676, 681, 133USPQ 275, 280 (CCPA 1962) (emphasis inoriginal). Accord In re Schaumann, 572 F.2d312, 316, 197 USPQ 5, 9 (CCPA 1978) (priorart genus encompassing claimed specieswhich disclosed preference for lower alkylsecondary amines and properties possessedby the claimed compound constituteddescription of claimed compound forpurposes of 35 U.S.C. 102(b)). C.f., In reRuschig, 343 F.2d 965, 974, 145 USPQ 274,282 (CCPA 1965) (Rejection of claimedcompound in light of prior art genus basedon Petering is not appropriate where theprior art does not disclose a smallrecognizable class of compounds withcommon properties.).23. An express teaching may be based ona statement in the prior art reference such asan art recognized equivalence. For example,see Merck & Co. v. Biocraft Labs., 874 F.2d804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir.),cert. denied, 493 U.S. 975 (1989) (holdingclaims directed to diuretic compositionscomprising a specific mixture of amilorideand hydrochlorothiazide were obvious over aprior art reference expressly teaching thatamiloride was a pyrazinoylguanidine whichcould be co-administered with potassiumexcreting diuretic agents, includinghydrochlorothiazide which was a namedexample, to produce a diuretic with desirablesodium and potassium eliminatingproperties). See also, In re Kemps, 97 F.3d1427, 1430, 40 USPQ2d 1309, 1312 (Fed. Cir.1996) (holding there is sufficient motivationto combine teachings of prior art to achieveclaimed invention where one referencespecifically refers to the other).24. E.g., Dillon, 919 F.2d at 696, 16USPQ2d at 1904. See also Deuel, 51 F.3d at1558, 34 USPQ2d at 1214 (‘‘Structuralrelationships may provide the requisitemotivation or suggestion to modify knowncompounds to obtain new compounds. Forexample, a prior art compound may suggestits homologs because homologs often havesimilar properties and therefore chemists ofordinary skill would ordinarily contemplatemaking them to try to obtain compoundswith improved properties.’’).25. E.g., Dillion, 919 F.2d at 693, 16USPQ2d at 1901.26. See id.27. E.g., In re Jones, 958 F.2d 347, 350, 21USPQ2d 1941, 1943 (Fed. Cir. 1992)(reversing obviousness rejection of noveldicamba salt with acyclic structure overbroad prior art genus encompassing claimedsalt, where disclosed examples of genus weredissimilar in structure, lacking an etherlinkage or being cyclic); In re Susi, 440 F.2d442, 445, 169 USPQ 423, 425 (CCPA 1971)(the difference from the particularly preferredsubgenus of the prior art was a hydroxylgroup, a difference conceded by applicant ‘‘tobe of little importance.’’).In the area of biotechnology, anexemplified species may differ from aclaimed species by a conservativesubstitution (‘‘the replacement in a protein ofone amino acid by another, chemicallysimilar, amino acid * * * (which) isgenerally expected to lead to either nochange or only a small change in theproperties of the protein.’’ Dictionary ofBiochemistry and Molecular Biology 97 (JohnWiley & Sons, 2d ed. 1989)). The effect of aconservative substitution on protein functiondepends on the nature of the substitution andits location in the chain. Although at somelocations a conservative substitution may bebenign, in some proteins only one amino acidis allowed at a given position. For example,the gain or loss of even one methyl group candestabilize the structure if close packing isrequired in the interior of domains. JamesDarnell et al., Molecular Cell Biology 51 (2ded. 1990).28. E.g., Dillion, 919 F.2d at 696, 16USPQ2d at 1904 (and cases cited therein).C.f. Baird, 16 F.3d at 382–83, 29 USPQ2d at1552 (disclosure of dissimilar species canprovide teaching away).29. Baird, 16 F.3d at 382–83, 29 USPQ2dat 1552 (reversing obviousness rejection ofspecies in view of large size of genus anddisclosed ‘‘optimum’’ species which differedgreatly from and were more complex than theclaimed species); Jones, 958 F.2d at 350, 21USPQ2d at 1943 (reversing obviousnessrejection of novel dicamba salt with acyclicstructure over broad prior art genusencompassing claimed salt, where disclosedexamples of genus were dissimilar instructure, lacking an ether linkage or beingcyclic).30. Baird, 16 F.3d at 382, 29 USPQ2d at1552. See also Jones, 958 F.2d at 350, 21USPQ2d at 1943 (disclosed salts of genusheld not sufficiently similar in structure torender claimed species prima facie obvious).31. For example, a claimed tetra-orthoesterfuel composition was held to be obvious inlight of a prior art tri-orthoester fuelcomposition based on their structural andchemical similarity and similar use as fueladditives. Dillion, 919 F.2d at 692–93, 16USPQ2d at 1900–02.Likewise, claims to amitriptyline used asan antidepressant were held obvious in lightof the structural similarity to imipramine, aknown antidepressant prior art compound,where both compounds were tricyclicdibenzo compounds and differed structurallyonly in the replacement of the unsaturatedcarbon atom in the center ring ofamitriptyline with a nitrogen atom inimipramine. In re Merck & Co., 800 F.2d1091, 1096–97, 231 USPQ 375, 378–79 (Fed.Cir. 1986).Similarly, a claimed protein compoundhaving an amino acid sequence includingMet-Phe-Pro-Leu-(Asp) 4-Lys-Y was held to beobvious in light of structural similarities tothe prior art. One reference providedmotivation to create fusion proteins in theforms X-(Asp) 4-Lys-Y. Other referencestaught positioning Met at the start of theamino acid sequence and that the sequencesPhe-Pro-Ile or Leu-Pro-Leu could serve as Xin the basic formula. The known structuralsimilarity of Ile and Leu meant thatappellants merely substituted one elementknown in the art for a known equivalent.Thus, the substitution was held to beobvious. In re Mayne, No. 95–1522, slip op.at 6–8 (Fed. Cir. Jan. 17, 1997).Other structural similarities have beenfound to support a prima facie case ofobviousness. E.g., In re May, 574 F.2d 1082,1093–95, 197 USPQ 601, 610–11 (CCPA1978) (stereoisomers); In re Wilder, 563 F.2d457, 460, 195 USPQ 426, 429 (CCPA 1977)(adjacent homologs and structural isomers);In re Hoch, 428 F.2d 1341, 1344, 166 USPQ406, 409 (CCPA 1970) (acid and ethyl ester);In re Druey, 319 F.2d 237, 240, 138 USPQ 39,41 (CCPA 1963) (omission of methyl groupfrom pyrazole ring).32. Id.33. Dillion, 919 F.2d at 697, 16 USPQ2d at1905; In re Stemniski, 444 F.2d 581, 586, 170USPQ 343, 348 (CCPA 1971).34. In re Albrecht, 514 F.2d 1389, 1392,1395–96, 185 USPQ 585, 587, 590 (CCPA1975) (The prior art compound so irritatedthe skin that it could not be regarded asuseful for the disclosed anesthetic purpose,and therefore a person skilled in the artwould not have been motivated to makerelated compounds.); Stemniski, 444 F.2d at586, 170 USPQ at 348 (close structuralsimilarity alone is not sufficient to create aprima facie case of obviousness when thereference compounds lack utility, and thusthere is no motivation to make relatedcompounds.).
6222 Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices35. Dillion, 919 F.2d at 697, 16 USPQ2d at1904–05 (and cases cited therein).36. E.g., id.37. Id. at 692, 16 USPQ2d at 1900–01.38. Dillion, 919 F.2d at 693, 696, 16USPQ2d at 1901, 1904. See also In reGrabiak, 769 F.2d 729, 731, 226 USPQ 870,871 (Fed. Cir. 1985) (‘‘When chemicalcompounds have ‘very close’ structuralsimilarities and similar utilities, withoutmore a prima facie case may be made.’’).39. Dillion, 919 F.2d at 697–98, 16USPQ2d at 1905; In re Wilder, 563 F.2d 457,461, 195 USPQ 426, 430 (CCPA 1977); In reLinter, 458 F.2d 1013, 1016, 173 USPQ 560,562 (CCPA 1972).40. See, e.g., Dillion, 919 F.2d at 692–97,16 USPQ2d at 1901–05; In re Grabiak, 769F.2d 729, 732–33, 226 USPQ 870, 872 (Fed.Cir. 1985).41. See e.g., In re May, 574 F.2d 1082,1094, 197 USPQ 601, 611 (CCPA 1978)(prima facie obviousness of claimed analgesiccompound based on structurally similar priorart isomer was rebutted with evidencedemonstrating that analgesia and addictionproperties could not be reliably predicted onthe basis of chemical structure); In reSchechter, 205 F.2d 185, 191, 98 USPQ 144,150 (CCPA 1953) (unpredictability in theinsecticide field, with homologs, isomers andanalogs of known effective insecticideshaving proven ineffective as insecticides, wasconsidered as a factor weighing against aconclusion of obviousness of the claimedcompounds).42. See, e.g., In re O’Farrell, 853 F.2d 894,903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).43. In re Bell, 991 F.2d 781, 784, 26USPQ2d 1529, 1531 (Fed. Cir. 1993); In reKulling, 897 F.2d 1147, 1149, 14 USPQ2d1056, 1057 (Fed. Cir. 1990).44. Kulling, 897 F.2d at 1149, 14 USPQ2dat 1058; Panduit Corp. v. Dennison Mfg. Co.,810 F.2d 1561, 1579 n.42, 1 USQP2d 1593,1606 n.42 (Fed. Cir.), cert. denied, 481 U.S.1052 (1987).45. E.g., Dillon, 919 F.2d at 692, 16USPQ2d at 1901.46. In re Soni, 54 F. 3d 746, 750, 34USPQ2d 1684, 1687 (Fed. Cir. 1995).47. In re Chu, 66 F.3d 292, 299, 36 USPQ2d1089, 1094–95 (Fed. Cir. 1995).48. E.g., Soni, 54 F.3d at 750, 34 USPQ2d1687; In re Piasecki, 745 F.2d 1468, 1474,223, USPQ 785, 789–90 (Fed. Cir. 1984).49. E.G., In re Huang, 100 F.3d 135, 139–40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996);In re De Blauwe, 736 F.2d 699, 705, 222USPQ 191, 196 (Fed. Cir. 1984).50. E.G., In re Soni, 54 F.3d 746, 750, 34USPQ2d 1684, 1687 (Fed. Cir. 1995) (errornot to consider evidence presented in thespecification). C.F., In re Alton, 76 F.3d 1168,37 UPSPQ2d 1578 (Fed. Cir. 1996) (error notto consider factual evidence submitted tocounter a section 112 rejection); In re Beattie,974 F.2d 1309, 1313, 24 USPQ2d 1040, 1042–43 (Fed. Cir. 1992) (<strong>Office</strong> personnel shouldconsider declarations from those skilled inthe art praising the claimed invention andopining that the art teaches away from theintention.); Piasecki, 745 F.2d at 1472, 223USPQ at 788 (‘‘(Rebuttal evidence) may relateto any of the Graham factors including the socalledsecondary considerations.’’).51. Graham v. John Deere Co., 383 U.S. at17, 148 USPQ at 467. See also, e.g., In rePiasecki, 745 F.2d at 1468, 1473, 223 USPQ785, 788 (Fed. Cir. 1984) (commercialsuccess).52. Rebuttal evidence may consist of ashowing that the claimed compoundpossesses unexpected properties. Dillon, 919F.2d at 692–93, 16 USPQ2d at 1901. Ashowing of unexpected results must be basedon evidence, not argument or speculation. Inre Mayne, No. 95–1522, slip op. at 9–10 (Fed.Cir. Jan. 17, 1997) (conclusory statementsthat claimed compound posses unusuallylow immune response or unexpectedbiological activity that is unsupported bycomparative data held insufficient toovercome prima facie case of obviousness).53. E.G., In re GPAC, 57 F.3d 1573, 1580,35 USPQ2d 1116, 1121 (Fed. Cir. 1995);Hybritech Inc. v. Monoclonal Antibodies, 802F.2d 1367, 1380, 231 USPQ 81, 90 (Fed. Cir.1986), cert. denied, 480 U.S. 947 (1987).54. E.G., In re Oelrich, 579 F.2d 86, 91–92,198 USPQ 210, 214 (CCPA 1978) (Expertopinions regarding the level of skill in the artwere probative of the nonobviousness of theclaimed invention.); Piasecki, 745 F.2d at1471, 1473–74, 223 USPQ at 790 (Evidenceof non-technological nature is pertinent tothe conclusion of obviousness. Thedeclarations of those skilled in the artregarding the need for the invention and itsreception by the art were improperlydiscounted by the Board); Beattie, 974 F.2dat 1313, 24 USPQ2d at 1042–43 (Sevendeclarations provided by music teachersopining that the art teaches away from theclaimed invention must be considered, butwere not probative because they did notcontain facts and did not deal with thespecific prior art that was the subject of therejection.).55. Id. See also In re Alton, 76 F.3d 1168,1174–75, 37 USPQ2d 1578, 1582–83 (Fed.Cir. 1996).56. The Federal Circuit has acknowledgedthat applicant bears the burden ofestablishing nexus, stating:In the ex parte process of examining apatent application, however, the PTO lacksthe means or resources to gather evidencewhich supports or refutes the applicant’sassertion that the sales constitute commercialsuccess. C.f. Ex parte Remark, 15 USPQ2d1498, 1503 ([BPAI] 1990) (evidentiary routineof shifting burdens in civil proceedingsinappropriate in ex parte prosecutionproceedings because examiner has noavailable means for adducing evidence).Consequently, the PTO must rely upon theapplicant to provide hard evidence ofcommercial success.In re Huang, 100 F.3d 135, 139–40, 40USPQ2d 1685, 1689 (Fed. Cir. 1996). See alsoGPAC, 57 F.3d at 1580, 35 USPQ2d at 1121;In re Paulsen, 30 F.3d 1475, 1482, 31USPQ2d 1671, 1676 (Fed. Cir. 1994).57. E.G., Paulsen, 30 F.3d at 1482, 31USPQ2d at 1676. (Evidence of commercialsuccess of articles not covered by the claimssubject to the 35 U.S.C. 103 rejection was notprobative of nonobviousness).58. E.g., In re Kulling, 897 F.2d 1147, 1149,14 USPQ2d 1056, 1058 (Fed. Cir. 1990); Inre Grasselli, 713 F.2d 731, 743, 218 USPQ769, 777 (Fed. Cir. 1983). In re Soni, 54 F.3d746, 34 USPQ2d 1684 (Fed. Cir. 1995) doesnot change this analysis. In Soni, the Courtdeclined to consider the <strong>Office</strong>’s argumentthat the evidence of non-obviousness was notcommensurate in scope with the claimbecause it had not been raised by theExaminer. 54 F.3d at 751, 34 USPQ2d at1688.When considering whether profferedevidence is commensurate in scope with theclaimed invention, <strong>Office</strong> personnel shouldnot require the applicant to show unexpectedresults over the entire range of propertiespossessed by a chemical compound orcomposition. E.g., In re Chupp, 816 F.2d 643,646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987).Evidence that the compound or compositionpossesses superior and unexpectedproperties in one of a spectrum of commonproperties can be sufficient to rebut a primafacie case of obviousness. Id.For example, a showing of unexpectedresults for a single member of a claimedsubgenus, or a narrow portion of a claimedrange would be sufficient to rebut a primafacie case of obviousness if a skilled artisan‘‘could ascertain a trend in the exemplifieddata that would allow him to reasonablyextend the probative value thereof.’’ In reClemens, 622 F.2d 1029, 1036, 206 USPQ289, 296 (CCPA 1980) (Evidence of theunobviousness of a broad range can beproven by a narrower range when one skilledin the art could ascertain a trend that wouldallow him to reasonably extend the probativevalue thereof.). But see, Grasselli, 713 F.2d at743, 218 USPQ at 778 (evidence of superiorproperties for sodium containingcomposition insufficient to establish the nonobviousnessof broad claims for a catalystwith ‘‘an alkali metal’’ where it was wellknown in the catalyst art that different alkalimetals were not interchangeable andapplicant had shown unexpected results onlyfor sodium-containing materials); In reGreenfield, 571 F.2d 1185, 1189, 197 USPQ227, 230 (CCPA 1978) (evidence of superiorproperties in one species insufficient toestablish the nonobviousness of a subgenuscontaining hundreds of compounds); In reLindner, 457 F.2d 506, 508, 173 USPQ 356,358 (CCPA 1972) (one test not sufficientwhere there was no adequate basis forconcluding the other claimed compoundswould behave the same way).
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ivFederal Register / Vol. 62, No. 2