Wisu Sul<\/p>\n
The scope of the claim depends on the meaning of each word in the claim. The indefiniteness standard requires that a patent specification \u201cconclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.\u201d[1]<\/a> In Nautilus, Inc. v. Biosig Instruments, Inc.<\/em>, the Supreme Court announced a new indefiniteness standard.[2]<\/a> The Court abrogated the Federal Circuit\u2019s previous inquiry into whether patent claims were \u201camenable to construction\u201d or \u201cinsolubly ambiguous.\u201d[3]<\/a> Under the new standard, a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.[4]<\/a> While the Supreme Court provides guidance for indefiniteness, the Federal Circuit is providing some helpful guidelines.<\/p>\n After the holding in Nautilus<\/em>, the Federal Circuit in Teva Pharms. USA, Inc. v. Sandoz, Inc.<\/em>, applied the new indefiniteness standard.[5]<\/a> The claim limitation at issue recited the term \u201cmolecular weight.\u201d[6]<\/a> Three relevant measures existed for molecular weight such as: (1) peak average molecular weight (\u201cMp\u201d); (2) number average molecular weight (\u201cMn\u201d); and (3) weight average molecular weight (\u201cMw\u201d).[7]<\/a><\/p>\n The Federal Circuit found the indefiniteness of the claim because the claims, specification, and prosecution history did not convey to one of skill in the art with reasonable certainty.[8]<\/a> Neither the claims nor the specification contained an explicit definition of molecular weight, and the prosecution history contained inconsistent statements.[9]<\/a> The Federal Circuit invalidated the patent for indefiniteness.[10]<\/a><\/p>\n In Dow Chem. Co. v. Nova Chems. Corp. (Can.)<\/em>, the Federal Circuit applied the Teva\u2019s indefiniteness standard again.<\/em>[11]<\/strong><\/em><\/a> The claim term at issue here provides for \u201ca slope of strain hardening . . . .\u201d[12]<\/a> Nova argued that the term is indefinite because the patent fails to teach with reasonable certainty where and how the \u201cslope of strain hardening\u201d should be measured.[13]<\/a><\/p>\n Dow\u2019s expert testified that \u201cone of ordinary skill in the art would know that the slope of the hardening curve would have to be measured at its maximum value . . . .\u201d[14]<\/a> However, four methods were known to measure the maximum slope.[15]<\/a> Neither the patent claims nor the specification discussed the four methods. Moreover, the prosecution history did not provide any guidance.[16]<\/a><\/p>\n The Federal Circuit held that the term in the claim is indefinite.[17]<\/a> The Federal Circuit emphasized that even Dow\u2019s expert, a person of ordinary skill in the art, had developed a method for measuring maximum slope, and the required guidance was not provided by the claims, specification, and prosecution history.[18]<\/a> The Federal Circuit invalidated Dow\u2019s patent because of the indefiniteness of the claim.[19]<\/a><\/p>\n Unlike Teva Pharms. USA, Inc.<\/em> and Dow Chem. Co.<\/em>, in Akzo Nobel Coatings, Inc. v. Dow Chem. Co.<\/em>, the Federal Circuit found that the claims were definite.[20]<\/a> Dow argued that: (1) \u201cviscosity below 10 Pa*s\u201d was indefinite because it failed to recite the temperature at which the viscosity measurement was to be taken; and (2) \u201ccarried out at a temperature between 5\u00b0C [41\u00b0F] to 150\u00b0C [302\u00b0F] above the melting point of the polymer\u201d was indefinite because it failed to specify which steps in the claimed process occurred at those elevated temperatures.[21]<\/a><\/p>\n First, the Federal Circuit determined that one of ordinary skill in the art would measure viscosity based on extrinsic evidence and intrinsic record.[22]<\/a> There were two pieces of extrinsic evidence: Dr. Mount’s declaration, and the American Society for Testing and Materials (\u201cASTM\u201d) protocol.[23]<\/a> Dr. Mount’s declaration recited that \u201cif a temperature is not specified for a given measurement, room temperature is implied.\u201d[24]<\/a> But the ASTM protocol did indicate that viscosity varies with temperature.[25]<\/a> The ASTM protocol disclosed that \u201c[a] test method [for] the determination of the apparent viscosity of hot melt adhesives . . . at temperatures up to 175\u00b0C [347\u00b0F], . . . [and] report[ing] the apparent viscosity at a given temperature along with the particulars . . . .\u201d[26]<\/a><\/p>\n The Federal Circuit held that one of ordinary skill in the art would understand that room temperature is implied for a viscosity measurement with no specified temperature.[27]<\/a> The Court also noted that the District Court did not clearly err in crediting Dr. Mount’s declaration over the ASTM protocol because the described method in the ASTM protocol only discussed \u201chot melt adhesives\u201d above 175\u00b0C (347\u00b0F) aims to find different viscosities over a range of temperatures.[28]<\/a><\/p>\n Moreover, the Federal Circuit found that the intrinsic record further supported the definiteness of the claim because room temperature is the only temperature mentioned at all in the patent\u00a0in connection with a viscosity measurement.[29]<\/a><\/p>\n Second, the Federal Circuit held that \u201ccarried out at a temperature between 5 \u00b0C [41\u00b0F] to 150 \u00b0C [302\u00b0F] above the melting point of the polymer\u201d limitation is definiteness based on the specification of the patent.[30]<\/a> Furthermore, the Federal Circuit emphasized Dow\u2019s burden of proof and noted that Dow did not provide any evidence to show that a person of ordinary skill in the art would not know the limitation with reasonable certainty, contrary to the clear meaning of the intrinsic record.[31]<\/a><\/p>\n In sum, the Federal Circuit found the claims definite, relying on extrinsic evidence and the intrinsic record. The Court also clarified that the party who alleges indefiniteness of the claim has the burden of proof.[32]<\/a><\/p>\n In Eli Lilly & Co. v. Teva Parenteral Meds., Inc.<\/em>, relying on expert testimony and the doctrine of claim differentiation, the Federal Circuit held that the claim is definite.[33]<\/a> The issue was indefiniteness of the term \u201cvitamin B12.\u201d[34]<\/a> Depending on the context, \u201cvitamin B12\u201d can be used in the art to refer either to cyanocobalamin specifically or, more broadly, to a class of compounds including pharmaceutical derivatives of cyanocobalamin.[35]<\/a><\/p>\n Eli Lilly’s expert testified that, although \u201cvitamin B12\u201d can refer to a class of compounds in other contexts, it refers specifically to cyanocobalamin when \u201cvitamin B12\u201d is prescribed in the medical field.[36]<\/a><\/p>\n The District Court relied on the expert\u2019s testimony and concluded that the term \u201cvitamin B12\u201d was definite.[37]<\/a> The Federal Circuit held that there is no clear error in the District Court\u2019s conclusion that \u201cvitamin B12,\u201d when used to refer to vitamin B12 supplementation in a medical context, refers to \u201ccyanocobalamin.\u201d[38]<\/a><\/p>\n The Federal Circuit also considered the doctrine of claim differentiation.[39]<\/a> Claim 1 listed both \u201cvitamin B12\u201d and cyanocobalamin as suitable agents for use in the claimed method. Claim 2 limited the agent to \u201cvitamin B12\u201d alone.[40]<\/a> If \u201cvitamin B12\u201d were to refer to a class of compounds, then claim 2 would be the same scope as claim 1.[41]<\/a><\/p>\n However, the doctrine of claim differentiation presumes that dependent claims are \u201cof narrower scope than the independent claims from which they depend.\u201d[42]<\/a> The Federal Circuit noted that reading the claims to require \u201cvitamin B12\u201d to be a specific compound would avoid rendering claim 2 narrower in scope than claim 1.[43]<\/a><\/p>\n In sum, the Federal Circuit found that a person of ordinary skill in the art would understand that \u201cvitamin B12\u201d in the claim referred specifically to cyanocobalamin in the realm of medical treatment, thereby providing \u201creasonable certainty\u201d as required under Nautilus<\/em>.[44]<\/a><\/p>\n To determine indefiniteness, the Federal Circuit considers extrinsic evidence, including expert testimony, and intrinsic record, such as claims, the structure of claims, and the specifications. These Federal Circuit decisions provide useful guidance for the Supreme Court\u2019s new indefiniteness standard.<\/p>\n [1]<\/a> 35 U.S.C. \u00a7 112.<\/p>\n [2]<\/a> See<\/em> 134 S. Ct. 2120, 2124 (2014).<\/p>\n [3]<\/a> Id.<\/em> at 2122.<\/p>\n [4]<\/a> See id.<\/em><\/p>\n [5]<\/a> See <\/em>789 F.3d 1335, 1338 (Fed. Cir. 2015).<\/p>\n [6]<\/a> Id.<\/em><\/p>\n [7]<\/a> Id.<\/em> at 1341.<\/p>\n [8]<\/a> Id.<\/em><\/p>\n [9]<\/a> Id.<\/em> at 1341\u201344.<\/p>\n [10]<\/a> Id.<\/em> at 1338.<\/p>\n [11]<\/a> See<\/em> 803 F.3d 620, 621 (Fed. Cir. 2015).<\/p>\n [12]<\/a> Id.<\/em> at 631.<\/p>\n [13]<\/a> Id.<\/em> at 633.<\/p>\n [14]<\/a> See<\/em> Dow Chem. Co. v. Nova Chems. Corp. (Can.), 458 F. App’x 910, 919 (Fed. Cir. 2012).<\/p>\n [15]<\/a> Dow Chem. Co.<\/em>, 803 F.3d at 631.<\/p>\n [16]<\/a> Id.<\/em> at 634.<\/p>\n [17]<\/a> Id.<\/em> at 635.<\/p>\n [18]<\/a> Id.<\/em> at 634.<\/p>\n [19]<\/a> Id.<\/em> at 621.<\/p>\n [20]<\/a> 811 F.3d 1334, 1345 (Fed. Cir. 2016).<\/p>\n [21]<\/a> Id.<\/em> at 1343.<\/p>\n [22]<\/a> Id.<\/em> at 1343\u201344.<\/p>\n [23]<\/a> Id.<\/em> at 1344.<\/p>\n [24]<\/a> Id.<\/em><\/p>\n [25]<\/a> Id.<\/em><\/p>\n [26]<\/a> Id.<\/em><\/p>\n [27]<\/a> Id.<\/em><\/p>\n [28]<\/a> Id.<\/em><\/p>\n [29]<\/a> Id.<\/em><\/p>\n [30]<\/a> Id.<\/em> at 1344\u201345.<\/p>\n [31]<\/a> Id.<\/em> at 1345.<\/p>\n [32]<\/a> Id.<\/em><\/p>\n [33]<\/a> 845 F.3d 1357, 1370 (Fed. Cir. 2017).<\/p>\n [34]<\/a> Id.<\/em><\/p>\n [35]<\/a> Id.<\/em><\/p>\n [36]<\/a> Id.<\/em><\/p>\n [37]<\/a> See<\/em> Eli Lilly & Co. v. Teva Parenteral Meds., Inc., No. 1:10-cv-1376-TWP-DKL, 2012 U.S. Dist. LEXIS 85369, at *26\u201328 (S.D. Ind. June 20, 2012).<\/p>\n [38]<\/a> 845 F.3d 1357 at 1371.<\/p>\n [39]<\/a> Id.<\/em><\/p>\n [40]<\/a> Id.<\/em><\/p>\n [41]<\/a> Id.<\/em><\/p>\n [42]<\/a> See<\/em> AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003).<\/p>\n\n
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