Insolubly Ambiguous By Any Other Name: How Nautilus v. Biosig Failed to Reform the Patent Indefiniteness Standard. Brett A. Zakeosian. I.

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1 Insolubly Ambiguous By Any Other Name: How Nautilus v. Biosig Failed to Reform the Patent Indefiniteness Standard Brett A. Zakeosian I. Introduction 35 U.S.C. 112 places a number of disclosure and claiming requirements on patentees. 1 The second paragraph of 112 imposes the definiteness requirement upon patent applicants, mandating that [t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor... regards as the invention. 2 While this statutory command seems to create a simple requirement for patentees to clearly claim their intellectual property, application of the definiteness requirement creates a number of difficulties. 3 The classic example is conflation of the definiteness requirement with the written description and enablement requirements of the first paragraph of 112, which require the patent applicant to separately contain a written description of the invention, and of the manner and process of making and using it, in such... terms as to enable any person skilled in the art... to make and use the same. 4 Earlier forms of 112 placed the definiteness, written description, and enablement requirements within the same sentence, which resulted in courts issuing decisions deriding the claim term as indefinite because the term failed to delineate the boundaries of the claim. 5 The same courts also conflated the definiteness requirement with the separate patent concepts of novelty and obviousness, stating that the patentee failed to separate his invention from the prior art, crossing different requirements of patentability U.S.C. 112(b) (2014). 2 Id. For the purposes of this article, 112(b) will be referred to as the second paragraph of See 3 Chisum on Patents U.S.C. 112(a) (2014). 5 See Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923). 6 See General Elec. Co. v. Wabash Appliance Co., 304 U.S. 364 (1938).

2 The 1952 Patent Act separated the requirement of definiteness from the written description and enablement requirements, but the definiteness problem turned away from earlier conflation issues and focused more specifically on the test employed to determine indefiniteness of claims. 7 The Federal Circuit took a softer approach towards the question of indefiniteness, adding flexibility while still making an attempt to define the claim. 8 This practice would continue throughout the 1990s, straining the flexibility requirement further until reaching a loose standard in Exxon Research & Eng g Co. v. United States. 9 There the Federal Circuit retooled indefiniteness, moving towards a reductionist analysis requiring the claim to be amenable to construction, finding indefiniteness only where the claim is insolubly ambiguous [] and no narrowing construction can properly be adopted. 10 Exxon Research turned indefiniteness analysis on its head, leading to the most patent-owner friendly indefiniteness analysis advanced by the Federal Circuit. Exxon Research and its progeny resulted in an unworkable indefiniteness standard, favoring patent owners and failing to give notice to wouldbe infringers of what patentees claimed. 11 Then, in the spring term of 2014, the Supreme Court granted certiorari in Nautilus, Inc v. Biosig Instruments, Inc., 12 a case challenging the insolubly ambiguous standard as a miscarriage of Supreme Court precedent and In a unanimous opinion, the Court reversed the Court of Appeals for the Federal Circuit, removing the insolubly ambiguous test for patent indefiniteness and installing a new standard, requir[ing] that a patent s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the 7 See, e.g. Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565 (Fed. Cir. 1985) 8 See, e.g. Andrew Corp. v. Gabriel Elecs. Inc., 847 F.2d 819 (Fed. Cir. 1988) F.3d 1371 (Fed. Cir. 2001). 10 Id. at See Christi J. Guerrini, Defining Patent Quality, 82 Fordham L. Rev (2014) S. Ct (2014). 13 Id. at

3 scope of the invention with reasonable certainty. 14 Early response from commentators was one of concern, noting that the indefiniteness standard may be moving away from a question of law and into factual territory. 15 More importantly, however, the Court did not provide guidance to the Federal Circuit regarding the proper analysis for the new standard, even going as far as to say that the Federal Circuit s old insolubly ambiguous analysis may cover reasonable certainty. 16 This article argues that the change enunciated by the Supreme Court is, in reality, merely semantic and will only have a de minimis effect on patent indefiniteness law. Part I will examine the history behind the indefiniteness requirement, combing the requirement s various incarnations from its statutory impetus in 1836 to the turbulent Exxon Research decision and its aftermath. 17 Part II examines the recent Nautilus decision and the vagueness with which the Supreme Court introduced the new standard. 18 Part III will analyze the apparent uselessness of the semantic change from insolubly ambiguous to reasonable certainty, citing the realities of claim construction, the focus on indefiniteness being decided as matter of law, and the relative rarity of cases amenable to construction yet indefinite under I. Not A Textbook Definition: A History of the Indefiniteness Requirement Congress first added a definiteness requirement to the federal laws via the Patent Act of 1836, requiring the patent applicant to particularly specify and point out the part, improvement, 14 Id. at 2129 (emphasis added). 15 See Dennis Crouch, Supreme Court: To Be Valid, Patent Claims Must Provide Reasonable Certainty Regarding the Claim Scope, PatentlyO (Jun. 2, 2014), 16 See Nautilus, 134 S.Ct. at See infra notes 20 to 96 and accompanying text. 18 See infra notes 97 to 121 and accompanying text. 19 See infra notes 122 to 164 and accompanying text. 3

4 or combination, which he claims as his own invention or discovery. 20 Before 1836, the Patent Act of 1793 required applicants to provide a description in such full, clear, and exact terms, as to distinguish the same from all other things before known, and to enable any person skilled in the art... to make and the use the same. 21 The 1793 Act, however, did not require any separate description of the metes and bounds of the claimed invention, instead relying upon the patentee to distinguish his invention from the prior art to obtain a patent. 22 Commentators believe that the 1836 Act meant to codify the Supreme Court s decision in Evans v. Eaton, 23 which, while more focused on the written description and enablement requirements, encouraged patent applicants to describe the invention in such full, clear, and distinct terms, as to distinguish the same from all other things before known. 24 The early response to Evans resulted in patent applicants specifically summarizing what they believed to be their invention and distinguishing such invention from the prior art; in response, courts began to limit the scope of the patent as defined in the specification. 25 Unfortunately, the legislative history of the 1836 Act leaves much to be desired, failing to explain whether Congress intended to require a separate claim after the specification, while courts still generally relied upon the patentee s prose-written specification. 26 This ambiguity required courts to continue determining the scope of the patent on a case-by-case basis, best described in the Supreme Court s decision in Winans v. Denmead, 27 which gave no credence to 20 Act of July 4, 1836, 5 Stat. 117, 119; see also T. Whitley Chandler, Prosecution History Estoppel, The Doctrine of Equivalents, and the Scope of Patents, 13 Harv. J. L. & Tech. 465, (2000). 21 Act of Feb. 21, 1793, 3 Stat. 318; see also Joshua D. Sarnoff, The Historic and Modern Doctrines of Equivalents and Claiming the Future, Part I ( ), 87 J. Pat. & Trademark Off. Soc y 371, (2005). 22 See Sarnoff, supra note 21 at U.S. 356 (1822). 24 Id. at 434; see also Sarnoff, supra note 21 at See Sarnoff, supra note 21 at Id. at U.S. 330 (1853). 4

5 the claim limitations placed at the end of the specification but interestingly did not limit the patentee to a particular embodiment or form. 28 Ironically, Winans would signal the beginning of the end for the traditional central claiming system, officially buried with the 1870 Patent Act, requiring patent applicants to particularly point out and distinctly claim the part, improvement, or combination which he claims as his invention or discovery. 29 The Supreme Court s decision in Merrill v. Yeomans 30 recognizes the death of central claiming, stating that the 1870 Act requires of the applicant a distinct and specific statement of what he claims to be new, and to be his invention --a patent claim structure known as peripheral claiming. 31 The introduction of peripheral claiming to the patent landscape, creating a separate patent claim at the end of the specification, began a focus on the claim language. This new importance of the claim would come to the forefront in Parks v. Booth, 32 an infringement case involving a patented improvement in grain-separators. 33 After summarizing a view of the claim language involved, Justice Clifford turns to an extended discussion of the requirements a patentee must fulfill before being granted a patent. 34 Stated in the context of patent claims constituting a new combination of old elements or devices, the Court found a combination is sufficiently describe[d]... if the devices of which it is composed are specifically named, their mode of operation given, and the new and useful result to be accomplished is pointed out, so that those skilled in the art and the public may know the extent and nature of the claim. 35 While the Patent Act of 1793 similarly forced patentees to define the boundaries of their inventions, the focus on the claim in Parks represents a full turn away from divining patent claim scope from the 28 See id. at ; see also Jeanne C. Fromer, Claiming Intellectual Property, 76 U. Chi. L. Rev. 719, 733 (2009). 29 Act of July 8, 1870, ch. 230, 16 Stat U.S. 508 (1877). 31 Id U.S. 96 (1880). 33 Id. 34 Id. at Id. at

6 full specification. 36 But separating the claim from the specification would result in a not-sodesired effect peripheral claiming handed patentees an ability to broaden their claims without direct proportionality to the specification, in turn requiring the courts to directly construe the claim language to determine the patent scope. 37 One would think that the claim s transformation into a separate, independent, sentencebased definition of the metes and bounds of the patent should have emphasized the importance of patent definiteness. However, the Court s jurisprudence would not evolve in such a clean fashion because the statutory scheme encompassing the definiteness requirement contained the disclosure requirements necessary to obtain a patent the enablement and written description requirements. 38 Enablement and written description stand separately of the claim definiteness issue, requiring patent applicants to describe their claims such that a person of ordinary skill in the art ( POSA ) would understand what the patentee possesses as his/her invention (written description) and enable the POSA to practice the claimed apparatus or process (enablement). 39 The problem was not one of determining who encapsulated the POSA, but rather one of determining the test to apply when a party sought to invalidate the patent for indefiniteness, a process the Supreme Court would seemingly change ad hoc based upon the nature of the challenge. 40 The best encapsulation of this enigma the definiteness test presented in the early 20th century is in Eibel Process Co. v. Minnesota & Ontario Paper Co. 41 The 1923 case involved a claimed improvement to an apparatus for making newsprint paper, known as a Fourdrinier 36 See Fromer, supra note 28 at See id. 38 See Act of July 8, 1870, ch. 230, U.S.C. 112(a) (2014); see also Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991). 40 See 3-8 Chisum on Patents U.S. 45 (1923) 6

7 machine. 42 A well-known process and apparatus at that time, the improvement the patent applicant claimed used a gravity feed to increase the speed of the machine, having the... roll end of the paper-making wire maintained at a high elevation, where by [pulp and water] is caused to travel by gravity faster than the normal speed of the wire. 43 The Supreme Court granted certiorari due to direct conflict between two Circuit Courts of Appeal, splitting on the validity of the patent claims. 44 The defendant s challenge, which held in the First Circuit, pointed towards the claims for a high angle of the gravity feed and substantial elevation with respect to the angle of the other paper feed rolls in the improved Fourdrinier machine. 45 The Supreme Court reversed the First Circuit, finding the terms high and substantial sufficiently definite in the context of the claims. 46 The Court initially starts the analysis by looking towards the specification, but looks at the disclosure with respect to what the patentee had in mind when designing his improvements. 47 While stating that the patent applicant had difficulty being more definite in his claims, the opinion objects to indefiniteness based on a failure to disclose to the public how the discovery... can be made useful... and how its infringement may be avoided, a standard closer to both enablement and written description. 48 The Court goes on to determine whether a POSA would be able to determine the correct angle for the improved machine, finding that one versed in paper making could find in [the] specification all he needed to know, to avail himself of the invention. 49 Interestingly, the Court 42 Id. at 47. Fourdrinier machines use a constantly moving mesh as a feed for paper pulp and water, over which the pulp is subject to rollers and heat to create a continuous sheet of paper. 43 Id. at 49, Id. at Id. at Id. 47 Id. 48 Id. 49 Id. at 66. 7

8 finishes its analysis by noting that case law previously found sufficient indefinite terms such as high and substantial to describe the invention or discovery. 50 The Court s definiteness jurisprudence would continue to be unsettled, but instead of mixing disclosure requirements into the definiteness analysis, the Court would begin to mix in tests for novelty. 51 The best example of this comingling of separate patent concepts occurred in General Electric Co. v. Wabash Appliance Co. 52 The patent at issue in Wabash concerned an improvement on tungsten filaments for light bulbs. 53 The patentee sought to remove two specific faults well-known in the art offsetting, a fault that involves crystal buildup across the filament resulting in faster burnout, and sagging, a positional change of the filament that may destroy the glass of the lamp and/or cool the filament, reducing efficiency. 54 While the district court found the applicant s course-grained tungsten crystal novel, the Circuit Court of Appeals found the patentee s claims anticipated. 55 The Court took up the case but, instead of reviewing the Circuit Court s decision regarding anticipation of the claim, invalidated the claim on its face for indefiniteness based on the use of the terms offsetting and sagging. 56 The Court once again begins its analysis by indicating that definiteness is a requirement of the patent laws, but then cuts into an analysis demanding the patent applicant adequately set out what he claims to be new, a patent requirement already embodied in novelty. 57 After finding that the patentee s claims failed to show a distinct improvement over the prior art, the Court then criticized the claim as 50 Id. 51 See Sanjeev K. Mahanta, Indefiniteness, 54 IDEA 497 (2014) U.S. 364 (1938). 53 Id. at Id. 55 Id. at Id. at Id. at

9 inadequately describing the claimed structure and overbroad with respect to the specification. 58 Unfortunately, this type of convoluted analysis pervaded the Court s patent claim jurisprudence until 1942, when the court would finally set out a term-by-term analysis. 59 United Carbon Co. v. Binney & Smith Co. 60 represents a fundamental change in the way courts would view the definiteness requirement going forward. The patent at issue revolved around an improvement for carbon black, a fundamental material in a very fine and dispersible powder. 61 The claims at issue sought to create aggregates of the carbon black through combinations of water and liquid hydrocarbons, wetting the particles and allowing them to bind together into substantially pure carbon black... aggregates... approximately one-sixteenth of an inch in diameter. 62 Following a Circuit Court holding that the claim was definite, petitioners appealed the holding, arguing that the terms substantially pure and approximately, among others, were definite enough for the purposes of the Patent Act. 63 The United Carbon Court distinguishes its analysis from earlier definiteness analyses by taking a term-by-term approach, first turning to the language of the claims and testimony regarding the language of the claims. 64 Using the specification as guide to the patent claims, as well as the testimony of patentee, the Court then determined whether the claim terms are truly specific enough for the POSA to understand, rather than quasi-applying tests of novelty, written description, or enablement. 65 The Court left patent applicants with a better understanding of the 58 Id. at See, e.g. Permutit v. Graver Corp, 284 U.S. 52 (1931) (holding that failure to claim particular aspects of space between zeolite water softening crystals and holding screen to be novelty issue instead of definiteness); see also Mahanta, supra note U.S. 228 (1942) 61 Id. at Id. at Id. at , Id. at 233. Notably, Justice Jackson notes the difficulty that even persons skilled in the art have when measur[ing] the inclusions or... appreciate[ing] the distinctions which may exist in the words of a claim. Id. 65 Id. at

10 definiteness calculus, stating that claims must be reasonably clearcut[sic] to enable courts to determine whether novelty and invention are genuine and warning that a zone of ambiguity [in] which enterprise and experimentation may enter only at the risk of infringement claims would discourage invention only a little less than unequivocal foreclosure of the field. 66 The Court finally commands that [a]n invention must be capable of accurate definition, and it must be accurately defined, to be patentable, marking the first step forward for a truly independent definiteness requirement until the Patent Act of The Patent Act of 1952 codified a number of distinctions made from patent case law, and the definiteness requirement represented no exception to the statutory overhaul. Congress modified the definiteness requirement in two ways. The first change regarded the language of the definiteness requirement, commanding that the specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention, putting patent applicants on notice that the court treated definiteness as a separate issue. Second, Congress separated the definiteness requirement from the written description and enablement requirements, codifying the definiteness requirement in its own paragraph in Both the legislative history and comments from the then Examiner-in-Chief of the Patent Office indicate that the separation intended to emphasize and distinguish definiteness as a separate requirement of patentability from written description and enablement. 69 This modification of the statutory language would finally allow federal courts to cut their teeth on a separate statutory command requiring definiteness. 66 Id. at Id. at 237; see Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342 (Fed. Cir. 2005) (recognizing United Carbon as progenitor of definiteness requirement). 68 Act of July 9, 1952, ch. 950, 66 Stat. 815 (codified at 35 U.S.C. 112 (1952)). 69 P.J. Frederico, Annotation, Patent Act of 1952, 35 U.S.C.A. 112 (West 1954); S. Rep. No , 1952 U.S.C.C.A.N. 2394, 2412 (1952). 10

11 The Court of Customs and Patent Appeals (C.C.P.A.) almost immediately seized on this language, separating the disclosure and definiteness requirements as per 112 s command. One notable example of the C.C.P.A. driving this wedge occurred in In re Borkowski, 70 a review of an examiner rejection regarding ambiguous language in a claim for oxygenating hydrocarbons. 71 The examiner rejected the application for enablement, stating that the term hydrocarbon encompasses an almost limitless number of compounds... not adequately supported by the somewhat limited disclosure, but citing to definiteness paragraph of The C.C.P.A. s decision is one of short and sweet distinction, telling the Patent Office that it cited to the wrong section of 112, and noting that the first sentence of the second paragraph of 112 is essentially a requirement for precision and definiteness of claim language. 73 The Patent Office advanced an analysis of 112 which would force the examiner to find the broadest invention supported by the disclosure and then determine whether the patentee s claims were broader than the invention conjured up by the examiner. 74 The C.C.P.A. rejected this analysis outright, sustaining that a lack of enablement does not render the claim imprecise or indefinite and commanding the Patent Office to distinguish its rejections as being either under the first paragraph (disclosure) or second paragraph of The Federal Circuit (created in 1982) carried the C.C.P.A s stance forward and set the stage for the next question regarding the scope of the definiteness requirement. After Congress finally gave patent district court holdings a new forum in the Court of Appeals for the Federal Circuit, the focus on the definiteness requirement turned towards what F.2d 904 (C.C.P.A. 1970). The Patent and Trademark Office utilizes a separate claim definiteness test based on the same statute, but the Federal Circuit adopted the C.C.P.A s stance regarding the separation of the first and second paragraphs of Id. at Id. at Id. at Id. 75 Id. 11

12 level of vagueness or ambiguity supported a rejection for indefiniteness under 112, 2. The Federal Circuit s early views on the definiteness requirement are best expressed in OrthoKinetics Inc. v. Safety Travel Chairs, Inc., 76 a case involving a claim for a children s scoliosis wheelchair designed to fit through a car door and into a car seat. 77 The language at issue claimed a wheelchair... improvement wherein [the] front leg portion is so dimensioned as to be insertable through the space between the doorframe of an automobile and one of the seats. 78 The patentee sued a competitor who blatantly copied the design and the competitor successfully argued at the district court level that the term so dimensioned was indefinite pursuant to The Federal Circuit ruled the claim term definite but the court s reasoning and standards are more important than the outcome. First, pursuant to the earlier decrees of the C.C.P.A, the Federal Circuit continued the divide between indefiniteness of the claim and the specification, citing the statutory distinction between the first and second paragraphs of The more important note in Orthokinetics is the ease with which the court moves towards a one-sentence standard for definiteness: A decision on whether a claim is invalid [for indefiniteness] requires a determination of whether those skilled in the art would understand what is claimed when the claim is read in light of specification. 81 The Court seemingly applies the standard with ease, noting that the claims are as definite as the subject matter permits, stating that the claims meant to cover a large number of automobiles which a POSA would understand in light of the specification. 82 The Court s enthusiastic chiding of the plaintiff expert s incorrect usage of the first paragraph standard shows the paradigm shift definiteness became a near presumption to F.2d 1565 (Fed. Cir. 1986) 77 Id. at Id. 79 Id. at Id. at Id. at Id. 12

13 the Federal Circuit, a wall that the Federal Circuit would continue to build. 83 The Federal Circuit s softer approach would continue on throughout the 1980 s and 1990 s, further softening the standard until 2001, when the Federal Circuit would turn towards the easiest patent definiteness standard required since the advent of peripheral claiming. Exxon Research & Eng g Co. v. United States 84 represented that soft turn and gave patent critics a new buzzword for patent definiteness: Insolubly ambiguous. The patents at issue in Exxon Research involved a method for activating a catalyst in the Fischer-Tropsch process, a chemical reaction pathway that converts natural gas into liquid hydrocarbons. Claim terms in the patent placed under the definiteness knife included substantial absence of slug flow, fluidizing the... catalyst, and particles of average diameter, terms held indefinite at the district court level. 85 In a controversial opinion, Judge Bryson expanded the allowance of indefiniteness in patent terms, first turning back towards the Supreme Court s opinion in United Carbon for the reason underlying the definiteness requirement the inherent imbalance between the zone of ambiguity and preciseness demanded of patent claims. 86 But Judge Bryson then diverts from the usual next step of applying the person having skill the in the art test and questions the application of the indefiniteness standard in the greater light of claim construction. 87 According to the Federal Circuit, the process of indefiniteness is so inextricably combined with claim construction that hardline application of the indefiniteness calculus would invalidate all claims where claim construction presented an issue. 88 Therefore, in a post Markman world, the Federal Circuit found it necessary to lower the indefiniteness bar to only those claims that are insolubly 83 Id F.3d 1371 (Fed. Cir. 2001). 85 Id. at Id. at Id. 88 Id. 13

14 ambiguous, and [for which] no narrowing construction can be properly adopted, while at the same time accommodating any patent where the meaning of the claim is discernible, even though the task may be formidable and the conclusion... one over which reasonable persons will disagree. 89 The court held that claims [are] indefinite only if reasonable efforts at claim construction prove futile, and also held that parties challenging the validity of the patent must overcome the statutory presumption of patent validity. 90 Application of the new standard to the facts in Exxon Research did not produce a dramatic result, but the mere annunciation of the new insolubly ambiguous standard was, and continues to be, met with derision and disbelief. 91 Most commentators focused on the softness of the insolubly ambiguous standard, noting that claims are invalidated for indefiniteness only in the most egregious circumstances, requiring the court to essentially throw its hands up and declare the term incapable of construction. 92 At least one commentator argues that the lower definiteness bar resulting from the Federal Circuit s run towards the Exxon Research standard effected patent clarity, creating ambiguous patent claims that failed to define the metes and bounds of the property right. 93 Others took square aim at the inclusion of claim construction and the presumption of validity, either seeking the abolishment of the insolubly ambiguous standard or lowering the burden of proof from clear and convincing pursuant to 35 U.S.C. 282 to preponderance of the evidence. 94 However, one issue maintained by all commentators 89 Id. See Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (holding that claim construction is performed as matter of law, not fact). 90 Id. (emphasis added). 91 See Christa J. Laser, A Definite Claim on Claim Indefiniteness: An Empirical Study of Definiteness Cases of the Past Decade with a Focus on the Federal Circuit and the Insolubly Ambiguous Standard, 10 Chi.-Kent J. Intell. Prop. 25 (2010); Christi J. Guerrini, supra 92 See Guerrini, supra note 91 at Id. 94 See Laser, supra note 90 at 27. The presumption of validity raised by 35 U.S.C. 282 attaches to validly issued patents challenged in federal court, requiring the challenger who alleges invalidity to prove said invalidity by clear and convincing evidence. 35 U.S.C. 282 (2012). The standard is lower in some proceedings before the Patent Office this article does not probe 14

15 pointed at the nexus between indefiniteness and claim construction, embracing the necessary tension between the definition of the claim term and its relative construction post Markman. 95 The various complaints of commentators would continue throughout the application of the insolubly ambiguous standard up until the Supreme Court, seventy years after its decision in United Carbon, decided to take issue with the Federal Circuit s analysis in III. The Supreme Court Strikes Back: Nautilus, Inc. v. Biosig Instruments, Inc. The patent involved in Nautilus, Inc. v. Biosig Instruments, Inc. 97, at first glance, does not appear to be the type of patent that would inspire a patent definiteness fight appealed to the Supreme Court. The invention at issue is directed to an improvement in heart rate monitors used in exercise machines. 98 Electrical signals accompany a number of human processes, including the electrocardiograph ( ECG ) or heart signals, and electromyogram ( EMG ) or skeletal muscle signals. 99 Heart rate monitors seek to measure the ECG signal and convert it into a numerical heartbeat, but prior art monitors were incapable of discerning between ECG and EMG signals, allowing EMG signals to mask ECG signals. 100 The patentee exploited a difference in the polarity of the signal waveforms detected from each hand ECG signals, due to the noninto matters before the Patent Office. See 35 U.S.C. 316(e) (2012) (setting evidentiary standard at preponderance of the evidence before Patent Trial and Appeal Board in Inter Partes Review). 95 See generally Joseph A. Biela, Claim Interpretation: A Claim Indefiniteness Analysis Proposal, 47 IDEA 561 (2007) (arguing for new claim indefiniteness analysis intertwined with claim construction based on the introduction of limited extrinsic evidence at earlier stage in construction). 96 See Mahanta, supra note 50 at (criticizing Datamize, LLC v. Plumtree Software, 417 F.3d 1342 (Fed. Cir. 2005) as upper limit of soft Federal Circuit claim construction and indefiniteness analysis); Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 896 (2014) (granting certiorari) S. Ct (2014). 98 Id. at Id. at Id. 15

16 vertical alignment of the heart, have opposite polarities from each hand, whereas the polarity of EMG signals are the same from each hand. 101 By using a difference amplifier, the claimed invention cancels out the EMG signals coming from each hand, allowing the measurement of the resulting clean ECG signal. 102 Claim 1 of the patent describes the heart-rate monitor apparatus in full, claiming a hollow cylindrical bar that a user grips with both hands, such that each hand comes into contact with two electrodes, one live and one common. 103 Biosig sued Nautilus for infringement after buying a company that used Biosig s technology without license and continuing to use the claimed invention. 104 Nautilus challenged a number of claim terms in Claim for definiteness under 112, 2, including the electrodes being mounted... in a spaced relationship with each other, the EMG signals being of substantially equal magnitude and phase, allowing the difference amplifier to produce a substantially zero [EMG] signal. 105 At the district court level, Nautilus obtained summary judgment on its indefiniteness argument regarding spaced relationship, with the court noting that the term failed to define either the distance of the space between the electrodes or any parameters. 106 The Federal Circuit reversed and remanded the matter, applying its insolubly ambiguous calculus and construing the claim, via intrinsic evidence, to determine that the distance separating the live and common electrodes cannot be greater than the width of a user s hands, as each electrode must measure an independent point on each hand. 107 A concurrence by Judge Schall indicated that despite the claim being amenable to construction, the various constructions presented might still maintain 101 Id. 102 Id. 103 Id. at Id. 105 Id.; U.S. Patent No. 5,337,753 (filed Jun. 9, 1992). 106 Nautilus, 137 S.Ct. at Id. 16

17 inherent ambiguities, pointing towards the functional linkage between the spaced relationship limitation and the removal of EMG signals. 108 Before the Supreme Court, Biosig and Nautilus quarreled over just how much imprecision 112, 2 tolerates. 109 Both Biosig and the Solicitor General of the United States urged the Court to hold that definiteness only requires reasonable notice of the scope of the claimed invention, harkening back to the earlier standards asking whether the patentee discerned his invention from the prior art. 110 Nautilus, on the other hand, urged the Federal Circuit standard, asking whether readers could reasonably interpret the claim s scope differently. 111 Before beginning the analysis, Justice Ginsburg noted that the both parties agreed to three constants regarding the indefiniteness standard: (1) definiteness is to be evaluated from the perspective of someone skilled in the relevant art.... [(2)] in assessing definiteness, claims are to be read in the light of the patent s specification and prosecution history.... [and (3)]... definiteness is measured from the viewpoint of a person skilled in [the] art at the time the patent was filed. 112 This, however, ends the divergence of the Court, Nautilus, and Biosig as the Court agrees with neither party regarding the statutory construction of 112, The Court s opinion opens with an attempt to reconcile the two competing positions. The Court first cites Festo Corp. 114 for the proposition that courts must recognize the inherent limitations of language, explaining that the Courts must tolerate uncertainty to provide appropriate incentives for innovation. 115 However, the court promptly moves to the notice 108 Id. at Id. at Id. 111 Id. 112 Id. at 2128 (citations omitted). 113 Id. at Festo Corp. v. Shotketsu Kinzoku Kogyo Kabuskiki Co., 535 U.S. 722 (2002). 115 Id. at

18 serving function that claims provide, turning to the feared zone of uncertainty noted in United Carbon. 116 After these two simple precepts, the court, cognizant of the competing concerns... read[s] 112, 2 to require that a patent s claims, viewed in light of the specification and prosecution history, inform those skill in the art about the scope of the invention with reasonable certainty. 117 In the Court s view, the standard... accords with [earlier Court opinions] stating that the certainty which the law requires in patents is not greater than is reasonable, having regard to their subject-matter. 118 The Court then turns its wrath towards the insolubly ambiguous standard extolled by the Federal Circuit, reasoning that insolubly ambiguous would simultaneously circumvent the notice requirement and also allow patentees to claim in the zone of uncertainty. 119 The Court did lend credence to Biosig s argument that insolubly ambiguous is merely a term of art, shorthand for a much larger inquiry. 120 However, while also remanding the matter to the Federal Circuit, the Court determined that the pervasiveness of the terms insolubly ambiguous and amendable to construction require that the Federal Circuit find a new term of art for the reasonably certain standard. 121 The Court took no effort to apply its new standard. 122 IV. Reasonable Certainty or Insolubly Ambiguous by Any Other Name The introduction of a new definiteness standard comes with a set of concerns and uncertainty regarding the application of reasonably certainty. Before delving into the main concerns regarding the new indefiniteness process, some issues with the Court s decision in 116 Id. at Id. 118 Id. at Id. at Id. 121 Id. at Id. at

19 Nautilus should be raised. First, while recognizing the competing tenets of providing the patentee room for invention and perceivable clarity of the patent claim, the court lays out a standard that lands somewhere in the middle but fails to provide a strong indication of what is necessary for claims to be held definite practitioners are only left with a indication that reasonable certainty only falls slightly more definite of the insolubly ambiguous standard. Second, the Court holds that the Federal Circuit s process may still be acceptable as a form of reasonable certainty, but the Court s command falls as a form of name checking the Federal Circuit as the Court provides only a one sentence reading of the statutory language and remands the matter to the Federal Circuit, failing to stand behind its own standard and review the de novo as the Court is entitled to under federal law. 123 Following Nautilus, the question should not be how exactly the standard stands modified, but rather why should patent litigators care about the difference between insolubly ambiguous and reasonable certainty. As mentioned above, the concerns regarding the new standard only seem to nudge reasonable certainty to a standard slightly above the old insolubly ambiguous standard, but the true indicator of patent definiteness remains unchanged claim construction. While federal courts will now have to find a claim construction that runs beyond the simple, amenable construction, reasonable certainty will still demand claim construction without definition, the indefiniteness calculus cannot be applied. Therefore, the switch from insolubly ambiguous to reasonable certainty is, except in the clearly egregious cases where there is no reasonable certainty, in reality merely a linguistic change that will have minimal bearing upon patent definiteness law. The first and strongest legal support this conclusion lies upon is that Nautilus does not modify the way court construe claims pursuant to federal case law, claim construction being a central location for courts to define the patent language and make the claim definite to a 123 Id. 19

20 reasonable certainty. Following Markman in 1996, courts construe claims as a matter of law, providing judges a large modicum of flexibility in claim constructions opinions outside typical evidentiary boundaries. 124 Two years later, the Federal Circuit began to review claim construction rulings de novo, allowing appellate panels to revisit claim term definitions with optional deference to district court conclusions of law. 125 Then, nine years after Markman, the Federal Circuit in Phillips v. AWH Corp. 126 clarified the proper claim construction calculus, placing intrinsic evidence the patent, file wrapper, and other documents associated with the patent s prosecution ahead of extrinsic evidence sources outside of patent prosecution documents. 127 The net result of these modifications to the claim construction process provides federal courts an expanded ability to render claim terms definite or indefinite for purposes of 112, 2 based upon relatively subjective views of both the trial and appellate courts. Claim construction is a difficult process for courts, and the surrounding indeterminism hardly provides the environment for a definite patent claim; between 1996 and 2003 the Federal Circuit reversed one-third of claim constructions rulings placed before the bench. 128 A good example of the difficulty and the indecisiveness inherent in claim construction comes by way of the Federal Circuit s ruling in Teva Pharms. USA, Inc. v. Sandoz, Inc. 129, a Hatch-Waxman litigation concerning a claim to copolymer-1, a polypeptide composed of four different amino acids. 130 The indefiniteness challenged launched by Sandoz and other generic 124 See Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996); see also Frank M. Gasparo, Markman v. Westview Instruments, Inc. and its Procedural Shockwave: The Markman Hearing, 5 J. L. & Pol y 723 (1997) (showing flexibility of judges to hear all types of evidence at Markman hearings). 125 See Cybor Corp. v. FAS Techs., 138 F.3d 1448 (Fed. Cir. 1998) F.3d 1303 (Fed. Cir. 2005). 127 Id. at See David L. Schwartz, Practice Makes Perfect? An Empirical Study of Claim Construction Reversal Rates in Patent Cases, 107 Mich. L. Rev. 223, 240 (2008) (measuring error rates of claim construction rulings in federal district courts) F.3d 1363 (2013), certiorari granted, 134 S. Ct (2014). 130 Id. at

21 drug manufacturers took issue with the term average molecular weight as applied to a statistical measure used to define copolymer-1, including peak average molecular weight, a single measurement of the most abundant molecule in the sample, and weight and number average molecular weight, statistical calculations based upon the overall sample. 131 The district court s Markman order construed molecular weight as the single measurement peak average, based upon succinct expert testimony, and held the term definite. 132 The Federal Circuit reversed and remanded, holding the terms indefinite because the various average molecular weights, despite their differences in calculation, are initially obtained from the same initial data. 133 The panel rolled the claim indefiniteness challenges directly into its own construction of the term average molecular weight, bypassing the specification and leaning heavily upon the prosecution history of the claim, where the examiner allowed the claims after patentee clarification that average molecular weight clearly referred to the peak. 134 The court further discounted the expert testimony claiming that a POSA would understand the average molecular weight to be peak, as measured by the highest point on a measurement curve. 135 The importance of the Teva litigation is not its result, but rather the incursion of claim construction processes into the indefiniteness calculus an attempt to remove the apparent claim ambiguity seen by the court. The term average molecular weight may actually carry an ambiguity, as those having skill in the art may have difficulty discerning between the particular average molecular weights involved, but the manner in which the court goes about construing the claim creates an ex ante definition which drives the indefiniteness analysis regardless of whether the claim must cross the bar of insolubly ambiguous or reasonable certainty the 131 Id. 132 Teva Pharms. USA, Inc. v. Sandoz, Inc., 810 F.Supp.2d 578, (S.D.N.Y. 2011). 133 Teva Pharms, USA, Inc., 723 F.3d at Id. at Id. 21

22 terms could be interchangeably used and the result the same. 136 While the change from insolubly ambiguous to reasonable certainty should have the effect of removing cases which only sought one amenable construction of a claim term to be definite, the panoply of claim construction rules, allowing courts to construe claims without deference nor a truly secure methodology will continue to rule indefiniteness challenges. Commentators also support the primacy of claim construction and the perfunctory role of the indefiniteness standard in 112, 2 challenges. At least one commentator points directly to the current claim construction rules extolled by the Federal Circuit, arguing that adoption of a single methodology focused on the patent, providing challengers notice and publicly available material. 137 Another commentator takes a more cynical approach to the interlocked nature of claim construction and indefiniteness, arguing that the nature of the process itself is bound to generate multiple plausible interpretations of a claim term, based upon the variables introduced by difference judges and the vast amount of evidence that may be presented at a Markman hearing. 138 One other group of commentators turned towards empirical evidence, citing an increasing trend in indefiniteness challenges as a function of the changes in the claim construction in the 1990s, noting that indefiniteness and claim construction rarely appeared as issues in its study of invalidity challenge outcomes in Claim construction, as it stands now under Markman and Phillips, will continue to run the outcomes of indefiniteness challenges far more than the indefiniteness standard applied, whether it be insolubly ambiguous or reasonable certainty. 136 See Greg Reilly, Completing the Picture of Uncertain Patent Scope, 91 Wash. U. L. Rev (2014) (arguing that current claim construction rules exacerbate patent indefiniteness issues and advocating more effective claim construction rather than changes to indefiniteness standards). 137 Id. at See Mahanta, supra note 51 at See John R. Allison, Mark A. Lemley & David L. Schwartz, Understanding the Realities of Modern Patent Litigation, 92 Tex. L. Rev. 1769, (2014). 22

23 The second pillar of support for the ineffectiveness of the semantic change in the indefiniteness comes from the law-based structure of the indefiniteness challenge. The history laid out infra in Section II represents a strong shift in how federal courts understood the indefiniteness requirement, starting from a point where indefiniteness acted as a substitute for disclosure and novelty related issues and developing into its own separate standard primarily through the modifications of the 1952 Patent Act and the Federal Circuit s soft, yet realistic approach towards claim indefiniteness. 140 The Supreme Court s presupposition in its attempt to balance the competing interests of notice serving and allowing for room in patent claiming sits on United Carbon a seminal case, but one that based its analysis and holdings upon the Wabash standard, which confused novelty and indefiniteness of the patent claim. 141 The large amount of change in the indefiniteness standard between 1942 and 2001 must, at a minimum, raise a question as to whether the Supreme Court s characterization of the zone of uncertainty, taken from seventy year old case law, represents the intricacies of patent claiming in the 21st century. The evolution of the Federal Circuit s standard from 1982 to 2001, providing patentees the ability to define their claim terms via the specification and the prosecution history, at a minimum provides a slight inconsistency to the use of the phrase zone of uncertainty moving forward. More importantly, however, the introduction of reasonable uncertainty does not change the fact that indefiniteness is performed as a matter of law, allowing courts to continue seeking old case law for much needed guidance for terms that appear ambiguous and uncertain. 142 A good example of this process centers around the word substantially in different contexts using different specifications, prosecution histories, or expert testimony, the term substantially may be considered definite or indefinite. However, courts reviewing the term substantially do 140 See Section II, infra notes 20 to 95 and accompanying text. 141 See Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2130 (citing United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236 (1942)). 142 See Nautilus, 134 S.Ct. at

24 so as a matter of law, meaning that the reviewing court may seek other cases where a court construed and analyzed the term substantially, providing another source of potential claim definiteness outside the reasonable certainty standard. This exact process occurred in Verve LLC v. Crane Cams, Inc. 143, a 2002 Federal Circuit case involving a claimed improvement in internal combustion engine pushrods. 144 The patentee claimed the improved pushrod comprising an elongated hollow tube... having substantially constant wall thickness throughout the length of the tube. 145 The district court found the term indefinite and granted summary judgment to the challenger, setting up an appeal to the Federal Circuit. 146 The Federal Circuit vacated the decision and remanded the matter to the district court, but the interesting component of the Crane Cams decision is the process by which Judge Newman reversed and remanded the matter. 147 Finding no support in the intrinsic evidence placed before the court and faced with the district court s decision finding the term indefinite for a lack of further definition based upon close prior art, the Court determined that the district court erred as a matter of law because further extrinsic evidence could still lend clarity to the claim terms. 148 But then the Court moved onto a general explanation of what the term substantially means in the patent context, apparently used... when warranted by the nature or the invention, in order to accommodate the minor variations that may be appropriate to secure the invention. 149 The Crane Cams court provided support to this explanation, citing earlier cases to summarize substantially as describ[ing] the invention with precision appropriate to the technology and without intruding on the prior art and as a means of avoid[ing] a strict numerical boundary to F.3d 1116 (Fed. Cir. 2002). 144 Id. at Id. at Id. at Id. at Id. at Id. 24