The text/ body of a patent application, i.e. the specification, (along with any figures) holds an important role in acquiring a patent, since it must describe how to make and use the invention,[i] and must describe the invention sufficiently that one working in the field would understand the scope of what the inventor has invented and wants to claim protection over.[ii] While these statutory demands are important, as one cannot acquire a patent if either of those requirements is missing, the specification also holds another critical function that is commonly overlooked, it helps define the scope and terms in the specification. In many ways, this is interconnected with the written description requirement, which controls the scope of the claims.
It determining the construction of claim terms, courts first look to the claims themselves, and the ordinary meaning given by a person in the field.[iii] The analysis then moves to the written description in the specification, the prosecution history of the application, and any extrinsic evidence introduced to define the terms.[iv] If, after analyzing the claims, written description, prosecution history, and any other evidence provided, a court or examiner cannot “inform, with reasonable certainty, those skilled in the art about the scope of the invention”, the claim is deemed indefinite.[v] However, the fact that a claim uses descriptive words, does not, in itself, mean a claim is indefinite,[vi] provided the descriptive word provides reasonable certainty and objective boundaries to the scope of the invention.[vii]
The specification can assist in the definition of claim terms and claim scope. A notable example is where the specification defines terms used in the specification.[viii] However, the examples provided in the specification,[ix] language used to describe the invention within specification,[x] are also used to determine meaning and scope within a claim.
To illustrate the use of the specification providing context to claim language, in Niazi Licensing Corp., the court analyzed the terms “resilient” and “pliable” in catheter tubing used in cardiac pacemaker surgery.
While the lower court found these terms undefined, the Federal Circuit noted that the specification provided a description of the resilient catheter having a braided design, listing exemplary materials in the specification and claims, and noting that the resilient catheter must be able to return to its original shape when subject to forces.[xi] Similarly, the “pliable” catheters included exemplary materials and noted the pliable catheter lacked braiding,[xii] and the court concluded the terms were broad but sufficiently understood to overcome the indefiniteness challenge.[xiii] Furthermore, another challenge to the patent involved the insertion and removal of the catheter from the patient, and whether the claims required the two catheters to be inserted and/or removed at the same time versus one after the other.[xiv] The court’s analysis focused on the examples, which included both simultaneous insertion of the catheters and sequential insertion of the catheters, resulting in the court concluded the claims cover both variations of the surgery.[xv]
Thus, the specification can provide objective boundaries, through exemplary designs, materials, uses, and embodiments of the invention.[xvi]
Relatedly, the specification can provide breadth to the patent claims. Claim scope can be supported by identifying characteristics of the invention, such as the full or partial structure, or properties, functional characteristics linked to the structure,[xvii] common features on various members of the claimed members,[xviii] and a representative number of variations of the invention.[xix] It is critical that the specification allow someone working in the field to determine what was invented, including the scope of what was invented.[xx] However, it is equally important to identify the important aspects of the invention, as a listing of hundreds or thousands of variations, without identifying the boundaries of the invention, can result in undefined claim scope.[xxi]
In Indenix Pharm. V. Gilead, the court looked at claims of potential infringement on a drug for treatment of hepatitis C infection. One issue on appeal pertained to the scope of the claims, which were drafted to cover the competing product, shown below.[xxii]
The patentee claimed the 2’ methyl group (CH3 at the bottom right) was key to the drugs’ effectiveness.[xxiii] The court noted that the claims, with the methyl group provided, cover billions of compounds.[xxiv] None of the formulas or examples in the patent show the fluorine of the competitor’s compound.[xxv]
The court noted there was no information in the patent on how to distinguish an effective drug from an ineffective drug, beyond the formulas specifically disclosed in the specification,[xxvi] and notably lists some variations that are supposed to be effective, but fails to explain why those compounds would be effective.[xxvii] This, in the court’s view, prevents one in the field from determining what compounds beyond those specifically listed, would have a similar result.[xxviii] The specification is a critical portion of the patent, and assists in providing scope and definiteness to the patent claims. In addition to its role in meeting the written description and enablement requirements of the patent laws, the specification also assists in defining claim terms, either expressly through providing definitions, or through the examples used, and language of the specification. Further, the specification can define the scope of claims, by providing a sufficient representation of the variation in the invention, identifying key requirements in the invention, and identifying features required in the invention. In many ways, the specification is as important as the claims in providing patent protection, and must be viewed as a critical aspect to the claims.
[i] 35 U.S.C. §112(a).
[ii] Id.
[iii] Catalina Marketing Int’l, Inc. v. Coolsavings,com, Inc., 289 F.3d 801, 807, 62 USPQ2d 1781 (Fed. Cir. 2002) (citing SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121, 227 USPQ 577, 585 (Fed. Cir. 1985); Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
[iv] Niazi Licensing Corp. v. St. Jude Medical, S.C., Inc., No. 2021-1864, slip opinion at 14 (Fed. Cir., Apr. 11, 2022) (citing Guangdong Alison Hi-Tech Co. v. Int’l Trade Comm’n, 936 F.3d 1353, 1360 (Fed. Cir. 2019)).
[v] Id. at page 9 (citing Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014)).
[vi] Id. at 10.
[vii] Id. at pages 10-11 (citing Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); Guangdong Alison Hi-Tech Co. v. Int’l Trade Comm’n, 936 F.3d 1353, 1359 (Fed. Cir. 2019).
[viii] Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)).
[ix] VLSI Technol. LLC v. Intel Corp., Nos. 2021-1826, 2021-1827, 2021-1828, slip opinion at page 11 (Fed. Cir., Nov. 15, 2022); Niazi Licensing Corp. at pages 14-16.
[x] Lite-Netics, LLC v. Nu Tsai Capital LLC, No. 2023-1146, slip opinion at 17 (Fed. Cir., Feb. 17, 2023) (stating language such as “present invention” can limit the scope of an invention). See also VLSI Technol. LLC at p11 (describing part of the invention to “include, but are not limited to, a wire bond pad, a probe pad, a flip-chip bump pad, a test point or other packaging or test pad structures that may require underlying structural support.” to support broad claim language).
[xi] Niazi Licensing Corp. at pages 14-15.
[xii] Id. at page 15.
[xiii] Id. at page 16.
[xiv] Id. at page 19.
[xv] Id. at pages 19-20.
[xvi] Id. at pages 13-14 (citing Guangdong Alison Hi-Tech Co., 936 F.3d at 1360).
[xvii] Enzo Biochem, Inc. v. Gen-Probe Incorp., 323 F.3d 956, 964, 63 U.S.P.Q.2d 1609 (Fed. Cir. 2002).
[xviii] Id. at965.
[xix] Regents of Univ. Cal. V. Eli Lilly and Co., 119 F.3d 1559, 1569, 43 USPQ2d 1398 (Fed. Cir. 1997).
[xx] Union Oil Co. of Cal. V. Atlantic Richfield Co., 208 F.3d 989, 997, 54 USPQ2d 1227 (Fed. Cir. 2000).
[xxi] Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895 (Fed. Cir. 1996).
[xxii] Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 1154-1155 (Fed. Cir. 2019),
[xxiii] Id. at 1154.
[xxiv] Id. at 1156.
[xxv] Id. at 1165 (the enantiomer was described).
[xxvi] Id. at 1164.
[xxvii] Id.
[xxviii] Id.
