S reexamine the 753 patent. 6 The PTO confirmed ince the U.S. Supreme - - PDF document

Volume 28 • Number 12 • December 2016 Intellectual Property & Technology Law Journal 9

S

ince the U.S. Supreme Court’s ruling in Nautilus,

• Inc. v. Biosig Instruments, Inc., several courts have

reviewed the indefiniteness of patent claims under the new “reasonable certainty” standard. Although it is difficult to gauge the full impact of the changed standard for indefiniteness, it appears that some types of claim terms are more vulnerable to being found indefinite than others. Patent practitioners can use the recent decisions on indefiniteness to shore up weaknesses in patent applications and claims or to exploit potential weaknesses in a com- petitor’s patent. Background On June 2, 2014, in Nautilus, Inc. v. Biosig Instruments, Inc.,1 the Supreme Court altered the standard (or at least the terminology) for indefi-

• niteness. At issue in the case was U.S. Patent No.

5,337,753 (’753 patent), which is directed to a heart- rate monitor for use during exercise.2 Figure 1 of the ’753 patent shows a perspective view of the claimed heart-rate monitor. The dispute between the parties arose in the 1990s, when Biosig allegedly disclosed the pat- ented technology to StairMaster Sports Medical Products, Inc.3 According to Biosig, StairMaster, without ever obtaining a license, sold exercise machines that included Biosig’s patented tech- nology, and Nautilus, Inc., continued to do so after acquiring the StairMaster brand.4 In 2004, based on these allegations, Biosig brought a pat- ent infringement suit against Nautilus in the U.S. District Court for the Southern District of New York.5 Thereafter, Nautilus requested that the U.S. Patent and Trademark Office (PTO) reexamine the ’753 patent.6 The PTO confirmed the patentability of the ’753 patent’s claims and Biosig reinstituted its infringement suit in the district court.7 The district court conducted a Markman hear- ing to determine the proper construction of the ’753 patent’s claims, including the phrase “spaced relationship.”8 After the conclusion of that hear- ing, Nautilus moved for summary judgment on the grounds that “spaced relationship,” as construed, was indefinite under 35 U.S.C. § 112, second para- graph.9 The district court granted the motion and Biosig appealed the decision to the U.S. Court of Appeals for the Federal Circuit. On appeal, the Federal Circuit stated that a claim is indefinite only when it is “not amenable to con- struction” or “insolubly ambiguous.”10 Under this standard, the majority determined that the ’753 patent was not indefinite, and therefore reversed the district court’s ruling and remanded the case for further consideration.11 The Supreme Court granted certiorari and subsequently vacated and remanded the case. In its Nautilus decision, the Supreme Court replaced the “amenable to construction” and “insol- ubly ambiguous” standards with a “reasonable cer- tainty” standard.12 Under this standard, a patent “is invalid for indefiniteness if its claims, read in light

• f 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.”13 Subsequent decisions applying the “reasonable certainty” standard have provided some guidance for patent practitioners wishing to raise indefiniteness challenges on this basis. Terms of Degree Applying the possibly more lenient post-Nautilus standard, some courts have invalidated claims due to overly subjective claim terms or terms of degree. In general, subjective terms are easier to challenge than objective ones. Although absolute precision

Michael J. T

• bin is an associate at the intellectual property

firm of Sughrue Mion, PLLC, assisting clients in building patent portfolios, inter partes matters, and general intellectual property

• counseling. Mr. T
• bin specializes in innovations in the chemical

arts and related fields. He may be reached at mtobin@sughrue. com.

Invalidating Patent Claims under Reasonable Certainty Standard

By Michael J. Tobin

10 Intellectual Property & Technology Law Journal Volume 28 • Number 12 • December 2016 is not required, the definiteness requirement man- dates clarity.14 For example, in Interval Licensing LLC v. AOL, Inc., several claims from two patents owned by Interval Licensing LLC were found invalid as indefinite.15 The patents were directed to an atten- tion manager for a display device and included the limitation that content was to be displayed “in an unobtrusive manner that does not distract a user … from a primary interaction.”16 The Federal Circuit held that “unobtrusive manner” failed to inform those skilled in the art about the scope of the invention with reasonable certainty.17 In its decision, the court stated that “unobtrusive manner” was a term of degree, and acknowledged that the Nautilus decision does not imply that terms

• f degree are inherently indefinite.18 The court

continued that “Claim language employing terms

• f degree has long been found definite where it

provided enough certainty to one of skill in the art when read in the context of the invention” and “Although absolute or mathematical precision is not required, it is not enough, as some of the language in our prior cases may have suggested, to identify ‘some standard for measuring the scope of the phrase.’ ”19 In making the foregoing statements, the court denounced Appellant’s reliance on case law applying the old standards of “amenable to construction” and “insolubly ambiguous,” which were replaced by Nautilus. The court concluded that, after review of the specification and prosecution history, “the ‘unob- trusive manner’ phrase has too uncertain a rela- tionship to the patents’ embodiments. Contrary to Interval’s suggestion, the wallpaper embodiment does not provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary.”20 Citing Nautilus, the court also declined to “cull out a sin- gle ‘e.g.’ phrase from a lengthy written description to serve as the exclusive definition of a facially sub- jective claim term.”21 Rather, the court noted that “Had the phrase been cast as a definition instead of as an example—if the phrase had been preceded by ‘i.e.’ instead of ‘e.g.’—then it would help provide the clarity that the specification lacks.”22 In a subsequent decision, Icon Health & Fitness,

• Inc. v. Polar Electro Oy, the Federal Circuit again

found that subjective claim terminology rendered the patent invalid for indefiniteness.23 In Icon, the claims in suit related to an exercise and health sys- tem including computerized equipment capable to provide feedback and encouragement to the user (i.e., a virtual personal trainer). Of importance, the claims recited the terms “in-band communication,” “out-of-band communication,” and “a relationship” between these communications.24 Based on the intrinsic record and substantial expert testimony from both parties, the district court concluded that those skilled in the art understand that the terms “in-band” and “out-of- band” are relative terms, and only have meaning in a given context with a defined reference, such as a frequency, a channel, a protocol, time slots, and data streams.25 The Federal Circuit affirmed the district court’s holding and added that “in-band” and “out-of-band” cannot provide a basis for one another.26 That is, even though there was a recited

Figure 1

Volume 28 • Number 12 • December 2016 Intellectual Property & Technology Law Journal 11 relationship between the two communications, they cannot each be limited in scope by the other as this would make the claim itself a moving target. The court’s decision elucidates the importance of defining an objective reference point for any rela- tive claim terms. However, as noted in Interval, terms of degree are not inherently indefinite. In Liberty Ammunition,

• Inc. v. United States, the Federal Circuit reversed the

trial court’s construction of the term “reduced area

• f contact,” a construction that would have other-

wise rendered the claim indefinite under Interval.27 The object claim was directed to a firearm projec- tile including an interface portion “disposed and dimensioned to define a reduced area of contact”

• f the body of the projectile with the rifling of

the firearm.28 The trial court held that “reduced area of contact” meant reduced as compared with any traditional jacketed lead bullets of varying calibers.29 The Federal Circuit reversed the trial court’s determination and instead preserved the definite- ness of the claim by construing “reduced area of contact” as being in comparison to only the NATO standard-issue M855 round for 5.56 mm projec- tiles and the M80 round for 7.62 mm projectiles.30 The court noted that the trial court’s construction would have rendered the claim indefinite: Claim 1 would not be defj nite had the trial court’s construction been correct because there would not be a suffj cient objec- tive boundary around the term of degree “reduced area of contact.” It is true that the trial court did objectively limit the claim language by including the “.17 through .50 BMG caliber” guidepost in its construc-

• tion. This standard is objective in the sense

that it defj nes a set range of calibers from which the baseline projectile may be drawn. Y et, even after limiting the fj eld of base- line projectiles according to the trial court’s construction, a multitude of candidates for the conventional baseline projectile would remain for each caliber within that range, making the claim indefj nite under Interval.31 The court characterized the holding in Interval as an “objective boundaries” standard and stated that a term of degree cannot be definite when construed in a manner that lends itself to a “sort of scattershot infringement analysis.”32 Variable Claim Terms Several other courts have invalidated claims that include parameters that can be measured in a variety of ways. Notably, many of the cases address terminology commonly used in the chemical and pharmaceutical industries, using measurements that would appear to be clear on their face. However, Nautilus has opened a door for patent challengers to find and exploit potential weaknesses based on insufficient patent disclosures. In a concurring opinion denying rehearing en banc, Judge Moore summarized the requirements for invalidating such claims: In many difg erent arts, measurement of some variable may be required (value, temperature, concentration, depth, dispersion, etc.). The burden of proving indefj niteness includes proving not only that multiple measurement techniques exist, but that one of skill in the art would not know how to choose among

• them. This knowledge of the skilled artisan is

part of the proof necessary for indefj niteness and the burden of proving it is on the chal- lenger of validity.33 One example of where the patent challenger was able to carry the burden of proving indefiniteness is Teva Pharm. USA, Inc. v. Sandoz, Inc.34 In Teva, the asserted claim related to a method of manufactur- ing a product called copolymer-1 which was used in the drug Copaxone.35 The claim recited that copolymer-1 was to have a “molecular weight” of about five to nine kilodaltons.36 However, the claim did not indicate which definition of molecular weight was to be used (i.e., peak average molecular weight (Mp), number average molecular weight (Mn), or weight average molecular weight (Mw)). The specification likewise did not provide a defini- tion of “molecular weight.”37 Each of Mp, Mn, and Mw are measured using different parameters and define distinct properties of a compound. In district court, Appellee T eva’s expert asserted that Mp is the only type of molecular weight that could be directly obtained from the analytical methods described in the specification, and there- fore the claims implicitly recited Mp.38 Appellant

12 Intellectual Property & Technology Law Journal Volume 28 • Number 12 • December 2016 Sandoz countered that the values of Mp could not be intended by the claim because the peaks (for determining peak molecular weight) in the fig- ures of the specification did not match the values reported in the legend.39 Sandoz also pointed out that, during prosecution of the claims, the applicants argued that one of ordinary skill in the art would have understood the kilodalton unit to imply weight average molecular weight (Mw).40 The dis- trict court dismissed Sandoz’s arguments and noted that all three molecular weight measurements could be measured in kilodaltons.41 Accordingly, the dis- trict court held that the term “molecular weight” was not indefinite.42 Sandoz appealed and the Federal Circuit, review- ing the district court’s holding de novo, reversed the judgement and found the claims to be indefinite.43 However, the Supreme Court granted certiorari and vacated and remanded the Federal Circuit’s deci- sion because, when reviewing the district court’s resolution of subsidiary factual matters during pat- ent construction, the Federal Circuit must apply the clear error standard.44 During its second review of the case, despite the stricter clear error standard, the Federal Circuit again reversed the district court’s holding and found the claims invalid as indefinite.45 Specifically, the court found that “molecular weight” does not have a plain meaning to one of ordinary skill in the art, and that based on the specification and prosecu- tion history “there is not reasonable certainty that molecular weight should be measured using Mp.”46 Similarly, in Dow Chem. Co. v. Nova Chemicals

• Corp. (Canada), the court found that the asserted

claims were indefinite under the Nautilus stan- dard.47 In Dow, the asserted claims of two patents both covered a type of plastic composition with several defined properties.48 At district court, the question of validity was left to a jury that returned a ruling in favor of patent owner Dow.49 Nova appealed, and the Federal Circuit, applying the pre-Nautilus stan- dards for indefiniteness, affirmed that the claims were definite and valid.50 While subsequent appeals related to supplemental damages were pending, the Supreme Court issued its Nautilus decision. Due to this change of law, the Federal Circuit reviewed the case and reversed the award of supplemental damages after finding the claims to be invalid for indefiniteness.51 The claims at issue in Dow recited a “slope of strain hardening coefficient” which was calculated using a slope of strain hardening.52 However, nei- ther the claims nor the specification provided suf- ficient guidance as to how to measure this slope

• f strain hardening.53 At trial, it was found that the

slope could be measured by at least four different methods that yielded disparate results. 54 The court noted that none of the claims, specification, or prosecution history discussed the four methods or provided any guidance as to which method should be used or even whether the possible universe of methods is limited to these four methods. The court discarded its previous holding that even if the slope can be measured in a variety of ways, the claims were still valid as long as a per- son of ordinary skill in the art could arrive at any method for measuring the slope.55 The court said that this is no longer sufficient under Nautilus. Accordingly, the court held that the claims were indefinite and would leave a “skilled artisan to con- sult the unpredictable vagaries of any one person’s

• pinion.”56

However, even if a variable term may be mea- sured in numerous manners, the term may yet be definite if the measurement techniques all arrive at similar results. For example, in Ethicon Endo-Surgery,

• Inc. v. Covidien, Inc., the Federal Circuit held that

four different methods for measuring an average clamping pressure all yielded similar results and therefore the term was not indefinite.57 This is in contrast to Dow and Teva where the different measurement techniques would provide disparate results. Additionally, a lack of guidance as to how a claimed parameter is measured does not necessar- ily render a claim indefinite. For instance, in Akzo Nobel Coatings, Inc. v. Dow Chem. Co., the claims and specification were silent as to the temperature for the claimed viscosity measurement, and viscosity can vary greatly depending on temperature.58 The court looked to extrinsic evidence and found that a person having ordinary skill in the art would have known to take the viscosity measurement at room temperature.59 Accordingly, the court found that the claims were not indefinite. Conclusion As the Federal Circuit stated in Dow, “there can be no serious question that Nautilus changed

Volume 28 • Number 12 • December 2016 Intellectual Property & Technology Law Journal 13 the law of indefiniteness. This was indeed the very purpose of the Nautilus decision.”60 Many post- Nautilus decisions appear to suggest that claims may be found indefinite more readily under the changed standard. The Federal Circuit recently noted that, “While we have not clarified the relationship between ‘insolubly ambiguous’ and ‘reasonably certain,’ it must be admitted that the ‘insolubly ambiguous’ standard is a harder threshold to meet than the post-Nautilus standard.”61 In particular, it seems that the claims most vul- nerable to be invalidated under the “reasonable certainty” standard are those including subjec- tive terms or variable terms (e.g., measurements). The subjective terminology may be more appli- cable in pharmaceutical patents, where claims may be directed to “onset” of a pharmaceutical “effect.” In such situations, a patent holder may preferably cast the claim in more measurable objective terms. However, the recent Federal Circuit decisions indicate that even objective claim terminology is susceptible to challenge. T

• invalidate chemical or

pharmaceutical claims, patent challengers can seek gaps in the patent disclosure or identify widely varying practices in an industry, such that a facially

• bjective term is amenable to varying interpreta-

tions that produce distinct results. On the other hand, patent holders would be well-advised to revisit how their claims describe the invention to assure that variations in measurable attributes do not lead to a wide range of possible values. Ample extrinsic evidence should be sought, regardless of the position taken. Notes

• 1. Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120

(2014).

• 2. See, e.g., Claim 1 of the ’573 patent.
• 3. Nautilus, 134 S. Ct. at 2126.
• 4. Id.
• 5. Id.
• 6. Id.
• 7. Id.
• 8. Biosig Instruments, Inc. v. Nautilus, Inc., No. 10 CIV

. 7722 AKH, 2011 WL 11745378 (S.D.N.Y . Sept. 29, 2011).

• 9. Id.
• 10. Biosig Instruments, Inc. v. Nautilus, Inc., 715 F

.3d 891, 898 (Fed. Cir. 2013), vacated, 134 S. Ct. 2120, 189 L.

• Ed. 2d 37 (2014) (citing Datamize, LLC v. Plumtree

Software, Inc., 417 F .3d 1342, 1347 (Fed.Cir.2005)).

• 11. Id.
• 12. Nautilus, 134 S.Ct. at 2129.
• 13. Id. at 2124.
• 14. Nautilus, 134 S.Ct. at 2130.
• 15. Interval Licensing LLC v. AOL, Inc., 766 F

.3d 1364, 1371 (Fed. Cir. 2014), cert. denied, 136 S. Ct. 59 (2015).

• 16. See, Claim 4 of U.S. Patent No. 6,034,652 and Claim 1
• f U.S. Patent No. 6,788,314.
• 17. Interval Licensing, at 1370.
• 18. Id.
• 19. Id.
• 20. Id. at 1373.
• 21. Id.
• 22. Id.
• 23. Icon Health & Fitness, Inc. v. Polar Electro Oy, No.

2015-1891, 2016 WL 4174951 (Fed. Cir. Aug. 8, 2016).

• 24. Id. at 3.
• 25. Id. at 5.
• 26. Id. at 6.
• 27. Liberty Ammunition, Inc. v. United States, No. 2015-

5057, 2016 WL 4488151, at 6 (Fed. Cir. Aug. 26, 2016).

• 28. See Claim 1 of U.S. Patent No. 7,748,325.
• 29. Liberty Ammunitions, at 5.
• 30. Id. at 6.
• 31. Id.
• 32. Id. at 7.
• 33. Dow Chem. Co. v. Nova Chemicals Corp. (Canada),

809 F .3d 1223, 1227 (Fed. Cir. 2015).

• 34. Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 F

.3d 1335 (Fed. Cir. 2015).

• 35. Id. at 1338.
• 36. See Claim 1 of U.S. Patent No. 5,800,808.
• 37. Teva, 789 F

.3d at 1338.

• 38. Id.
• 39. Id.
• 40. Id. at 1339.
• 41. Id.
• 42. Id.
• 43. Teva Pharm. USA, Inc. v. Sandoz, Inc., 723 F

.3d 1363, 1368 (Fed. Cir. 2013), vacated, 135 S. Ct. 831 (2015).

• 44. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831,

833 (2015), abrogating Lighting Ballast Control LLC v. Philips Electronics N. Am. Corp., 744 F .3d 1272.

• 45. Teva, 789 F

.3d at 1345.

• 46. Id.
• 47. Dow Chem. Co. v. Nova Chemicals Corp. (Canada),

803 F .3d 620 (Fed. Cir. 2015).

• 48. See Claim 6 of U.S. Patent No. 5,847,053 and Claim 1
• f U.S. Patent No. 6,111,023.
• 49. Dow Chem. Co. v. Nova Chems. Corp., 726 F

.Supp.2d 459, 463–64 (D.Del.2010).

14 Intellectual Property & Technology Law Journal Volume 28 • Number 12 • December 2016

• 50. Dow Chem. Co. v. Nova Chems. Corp., 458 Fed.Appx.

910, 911, 917–18 (Fed.Cir.2012).

• 51. Dow, 803 F

.3d at 635 (citations omitted).

• 52. Id. at 631.
• 53. Id.
• 54. Id. at 633.
• 55. Id. at 634.
• 56. Id.
• 57. Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F

.3d 1312, 1321 (Fed. Cir. 2015).

• 58. Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F

.3d 1334 (Fed. Cir. 2016).

• 59. Id. at 1345.
• 60. Dow, 803 F

.3d at 630. 61. Koninklijke Philips N.V . v. Zoll Med. Corp., No. 2014- 1764, 2016 WL 4045330, at *19 (Fed. Cir. July 28, 2016).

As orginially published in Intellectual Propery & Technology Journal.