In Nevro Corp. v. Boston Scientific Corporation, [2018-2220, 2018-2340] (April 9, 2020) the Federal Circuit vacated and remanded the District Court determination on summary judgment that claims 7, 12, 35, 37 and 58 of U.S. Patent No. 8,712,533, claims 18, 34 and 55 of U.S. Patent No. 9,327,125, claims 5 and 34 of U.S. Patent No. 9,333,357, and claims 1 and 22 of U.S. Patent No. 9,480,842 were indefinite. The claimed invention purportedly improves conventional spinal cord stimulation therapy by using waveforms with high frequency elements or components, which are intended to reduce or eliminate side effects.

The district court determined that “paresthesia-free” has a “clear meaning,” namely that the therapy or therapy signal “does not produce a sensation usually described as tingling, pins and needles, or numbness.” The district court therefore held that the term “paresthesia-free” does not render the asserted method claims indefinite. does not render the asserted method claims indefinite. Id. The district court held indefinite, however, the asserted “paresthesia-free” system and device claims. It held that infringement of these claims depended upon the effect of the system on a patient, and not a parameter of the system or device itself and therefore, “a skilled artisan cannot identify the bounds of these claims with reasonable certainty.”

Claims, viewed in light of the specification and prosecution history, must “inform those skilled in the art about the scope of the invention with reasonable certainty.” This standard “mandates clarity, while recognizing that absolute precision is unattainable.” The Federal Circuit concluded that the district court correctly determined that the “paresthesia-free” method claims are not indefinite, but that it erred in holding indefinite the “paresthesia-free” system and device claims. The test for indefiniteness is not whether infringement of the claim must be determined on a case-by-case basis. Instead, it is simply whether a claim “inform[s] those skilled in the art about the scope of the invention with reasonable certainty.”

The Federal Circuit said that “paresthesia-free” is a functional term, defined by what it does rather than what it is, but that that does not inherently render it indefinite. In fact, the Federal Circuit said that functional language can promote definiteness because it helps bound the scope of the claims by specifying the operations that the claimed invention must undertake. When a claim limitation is defined in purely functional terms, a determination of whether the limitation is sufficiently definite is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). The ambiguity inherent in functional terms may be resolved where the patent provides a general guideline and examples sufficient to enable a person of ordinary skill in the art to determine the scope of the claims.

The Federal Circuit found that the specification teaches how to generate and deliver the claimed signals using the recited parameters. Accordingly, a person of ordinary skill would know whether a spinal cord stimulation system, device or method is within the claim scope. Thus, the patents provide reasonable certainty about the claimed inventions’ scope by giving detailed guidance and examples of systems and devices that generate and deliver paresthesia-free signals with high frequency, low amplitude, and other parameters.

The Federal Circuit rejected Boston Scientific’s argument that the “paresthesia-free” claims are indefinite because infringement can only be determined after using the device or performing the method. The Federal Circuit said that “Definiteness does not require that a potential infringer be able to determine ex ante if a particular act infringes the claims.”

Several of the claims recited a signal generator “configured to” generate a therapy signal with certain parameters and functions. The district court concluded that “configured to” could be “reasonably construed to mean one of two things: (1) the signal generator, as a matter of hardware and firmware, has the capacity to generate the described electrical signals (either without further programing or after further programming by the clinical programming software); or (2) the signal generator has been programmed by the clinical programmer to generate the described electrical signals. Because the term was susceptible to two different constructions, the district court concluded that “configured to” made the claims indefinite.

The Federal Circuit said that this was the incorrect legal standard. The test for indefiniteness is whether the claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty. The Federal Circuit said that the test is not merely whether a claim is susceptible to differing interpretations, as such a test would render nearly every claim term indefinite so long as a party could manufacture a plausible construction. The Federal Circuit held that “configured to” does not render the claims indefinite.

Several of the claims included the limitation “means for generating” a paresthesia-free or non-paresthesia-producing therapy signal. The district court determined that there was not an adequate disclosure of a corresponding structure in the patent specification and sua sponte held the claims indefinite.

The Federal Circuit noted that the specification clearly recites a signal or pulse generator, not a general-purpose computer or processor, as the structure for the claimed “generating” function. The Federal Circuit furtner noted that the specification teaches further how to configure the signal generators to generate and deliver the claimed signals using the recited parameters, clearly linking the structure to the recited function. The Federal Circuit reversed the finding of indefiniteness.

Finally, all but four of the claims used the term “therapy signal,” which the district court construed as an “electrical impulse” or “electrical signal,” but which the patent owner argued meant “a spinal cord stimulation or modulation signal to treat pain.”

The Federal Circuit disagreed that the specification met the exacting standard of define “therapy signal” as the Federal Circuit found. The Federal Circuit also rejected the argument that the language was indefinite, holding that the fact that a signal does not provide pain relief in all circumstances does not render the claims indefinite. The Federal Circuit held that the district court incorrectly construed the claim, but correctly determined that the claim was not indefinite.

In Eko Brands, LLC, v. Adrian Rivera Maynez Enterprises, Inc., [2018-2215, 2018-2254] (January 13, 2020), the Court of Appeals for the Federal Circuit affirmed the judgment of invalidity of U.S. Patent No. 8,720,320 owned by ARN, on an adaptor device for use with Keurig® single-brew coffee machines and of infringement of U.S. Patent No. 8,707,855 owned by EKO on a reusable filter cartridge device for use with single-serve beverage brewing machines.

On appeal ARM argued that brewing chamber in the claims of the ‘320 patent required a closed chamber, and thus the prior art did not make the claimed invention obvious.  The Federal Circuit distinguished other patents that showed closed brewing chamber, noting that these specifically describe the chamber as sealed. The Federal Circuit also rejected the argument that several embodiments of in the ‘320 patent that showed sealed brewing chambers, meant that brewing chamber had to be sealed, because there were also several embodiments with unsealed brewing chambers.  The Federal Circuit applying the Canon of Claim construction that “a claim construction that ‘excludes the preferred embodiment is rarely, if ever, correct and would require highly persuasive evidentiary support” to find that the district court’s construction was correct.  The Federal Circuit also affirmed the award of attorneys fees to the accused infringer of the ‘320 patent.

On the issue of infringement of the ‘855 patent, ARM argued that the claims of the patent required a single serve beverage brewer (“A beverage brewing device for use with a single serve beverage brewer having a brewing holster . . .”).  The Federal Circuit disagreed, noting that on its face does not require a beverage brewer, even if the preamble is limiting. To the extent that claim mentions a beverage brewer it is only as a “reference point” to define the purpose and structure of the brewing device.  Thus the Federal Circuit affirmed the finding of infringement.  The Federal Circuit also affirmed the finding of no willful infringement, noting that the instruction as a whole was not legally erroneous given the limited nature of Eko’s objection.

Amgen, Inc. v. Amneal Pharmaceuticals LLC, [2018-2414, 2019-1086] (January 7, 2020), the Federal Circuit vacated and remand the district court’s judgment that Amneal did not infringe U.S. Patent 9,375,405, and affirmed that Piramal did not infringe and that Zydus did infringe the ‘405 patent.

On appeal Amgen challenged the district court’s construction of a Markush group of binders:

from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mix-tures thereof

and a Markush group of disintegrants:

from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovid[o]ne, sodium starch glycolate, croscarmellose sodium, and mixtures thereof

The district court held both of these Markush groups were closed, such that additional binder and disintegrant substances in addition to the ones specified in the Markush ground avoided infringement.

The Federal Circuit said that Multilayer and Shire did not hold broadly that, whenever “consisting of” Markush group language is present in a particular claim limitation, even when the limitation follows a general claim transition phrase of “comprising,” all components of an accused product that perform the general function of the particular limitation must meet the requirements of that limitation, thus precluding components outside the Markush group.  The Federal Circuit explained that those decisions do not apply in this case, where the question is whether the “binder” or “disintegrant” claim limitations are written to preclude other binders and disintegrants in the claimed composition. The Federal Circuit concluded that they are not.

In Multilayer, the Markush group was closed because the language of the claim was closed, requiring “each layer being selected from the group consisting of . . . “.  In Multilayer the Federal Circuit further held that dependent claim 10, which added a requirement that “at least one said inner layer” contain a resin not listed in the element, was invalid because it was inconsistent with the independent claim.  In particular, the Federal Circuit said, it had no occasion to, and did not, consider the effect of the transition phrase “comprising”.

In construing the (a) and (b) Markush groups in Shire, the Federal Circuit explained that the “consisting of” language defined the groups and created a “very strong presumption” that the Markush groups were closed to additional elements not specified in the claim.  The Federal Circuit pointed out that this was also decided without reference to the comprising transition.  The claim specified that  the outer matrix of the claimed composition “consists of” the compounds in the Markush group. The outer matrix, by the terms of the element, had to “consist of” of those compounds to meet that limitation.

The Federal Circuit found that the decisive issue in the current case is critically different from any issue decided in Multilayer or Shire. The issue is whether all binders or disintegrants in the claimed formulation are subject to the specific binder or disintegrant limitations. The Federal Circuit concluded that they were not.  First, the Federal Circuit noted that there is no language in Amgen’s claim indicating that every binder or disintegrant in the claimed formulation must be within the Markush groups.  The Federal Circuit said that the limitations merely require that those particular binders or disintegrants meet the specified weight-percentage requirements, which is not inconsistent with the overall composition containing other binders or disintegrants.

The Federal Circuit said that the plain language of the claim requires “at least one” of the Markush members and certainly does not indicate that the only binders and disintegrants in the claimed formulation are those listed in the groups. The Federal Circuit did not see a sufficient basis for a different conclusion in the specification or in the prosecution history.  The Federal Circuit also noted the transition “comprising,” which makes clear that the claim does not preclude the presence of components or steps that are in addition to, though not inconsistent with, those recited in the limitations that follow.  The Federal Circuit said that the use of the “comprising” transition phrase reinforces the conclusion that the language of those limitations is best construed not to foreclose such additional binders and disintegrants. The Federal Circuit vacated the district court’s decision as to the Amneal product.  However, the Federal Circuit agree that prosecution history estoppel prevented Amgen from asserting that Piramal’s product infringed under the doctrine of equivalents.

In In re Fought and Clanton, [2019-1127](November 4, 2019) the Federal Circuit reversed the PTAB decision that the claims 1 and 2 in U.S. Application Serial No. 13/507,528 were anticipated.

The claims were directed to travel trailer with a movable garage wall. Claim 1 read:

The Examiner rejected both claims 1 and 2 as anticipated. The Board affirmed the examiner’s rejection, concluding the preamble term “travel trailer” is a mere statement of intended use that does not limit the claim.

The Federal Circuit rejected appellants first argument that “A travel trailer having” was not a preamble, noting though this claim does not use the typical claim language (comprising) which denotes the transition be-tween the preamble and the body, the word “having” performs the same role.

Appellants next argument was that even if “travel trailer” is part of the preamble, it is limiting because limitations in the body of the claims rely on “travel trailer” for antecedent basis and for structural limitations. On this point, the Federal Circuit agreed, noting that it has repeatedly held a preamble limiting when it serves as antecedent basis for a term appearing in the body of a claim. Appellants provided extrinsic evidence to support their assertion that “travel trailer” is a specific type of recreational vehicle that includes a living quarters. The Federal Circuit said:

Based on the extrinsic evidence, we conclude that a “travel trailer” is a specific type of recreational vehicle and that this term is a structural limitation of the claims. There is no dispute that if “travel trailer” is a limitation, Dietrich and McDougal, which disclose cargo trailers and shipping compartments, do not anticipate. Just as one would not confuse a house with a warehouse, no one would confuse a travel trailer with a truck trailer.

The Federal Circuit rejected appellant’s argument that the Patent Office had an obligation to identify the level of ordinary skill in the art — at least where the applicant had not put it in issue.

Whether a preamble is a limitation is a two-edged sword for applicants, one the one hand if the preamble is a limitation, it can make the claim patentable, but on the other hand it can also make the claims harder to infringe, Where the applicant wants the preamble to be a limitation, purposely using the words in the body of the claim will achieve that goal, however idly parroting the words of the preamble in the body can unintentionally limit the claims for purposes of infringement.

Claims often reference government or industry standards. However standards can change over time, which has the potential to change the scope of the claim, unless it is understood that the meaning is fixed as of the filing date, and that is what the BPAI does.

In Ex parte McClary, Appeal 2009-001300, Application 11/101,897 (May 17, 2010), the Board reversed the Examiner’s 112 rejection that reference to the ARINC 615 protocol (an industry standard in the field of avionics) was indefinite because it was subject to being changed in the future. The Board said:

Compliance with the provisions of 35 U.S.C. § 112 is determined as
of the filing date of the application. W.L. Gore & Assoc., Inc. v. Garlock,
Inc., 721 F.2d 1540, 1556 (Fed. Cir. 1983). There does not appear to be any
dispute here that a particular version of the ARINC 615 protocol was in
existence as of Appellant’s filing date. Thus, one of ordinary skill in the
art, with reference to the standard in effect as of the filing date of
Appellant’s application, would readily be able to determine the metes and bounds of this element found in claims 10 and 12. Accordingly, we will not sustain the rejection of claims 10 and 12 under 35 U.S.C. § 112, second paragraph, as being indefinite.

Some drafters affirmatively control the meaning of their claims by expressly referencing the standard or protocol “in effect on the filing date.

Claim 11 of U.S. Patent No. 9,945,005 provides:

11. The method according to claim 1 wherein the material is leached for a sufficient period of time that the residue after leaching meets the EPA TCLP limits according to EPA Test Method 1311 procedure in effect on the filing date of this application.

Claim 27 of U.S. Patent No. 7,043,402 provides:

27. The system of claim 20, wherein said electrical indication means is comprised of at least one of: (a) a serial communications port; (b) a bi-directional serial data bus chosen from among standards SAE/TMC J1708/J1587 protocol in effect on the filing date hereof, or SAE J1939 communications protocol in effect on the filing date hereof; (c) a CAN data bus; (d) a RF device; and/or (e) an IR device.

Claim 16 of U.S. Patent No. 6,889,385 provides:

16. The apparatus of claim 8 wherein said DOCSIS cable modem is compatible with any DOCSIS national standard for cable modems as of the filing date of the parent patent application of this patent application.

While claims referencing standards are not indefinite merely because the standard could be changed in the future, claim drafters still have to account for how infringement can be proved if the standard is in fact changed.

In Iridescent Networks, Inc. v. AT&T Mobilitiy, LLC, [2018-1449] (August 12, 2019), the Federal Circuit affirmed judgment of non-infringement of U.S. Patent No. 8,036,119, on System and Method of Providing Bandwidth on Demand, affirming the district court’s construction of “high quality of service connection.”

The ’119 patent discloses a system and method for managing network traffic routes and bandwidth availability to minimize adverse network conditions and to assure that the network connection maintains a requested minimum level of one of these three parameters. Iridescent proposed broadly construing the claim term “high quality of service connection” to mean “a connection in which one or more quality of service connection parameters, including bandwidth, latency, and/or packet loss, are assured from end-to-end based on the requirements of the application.” The magistrate judge, however, largely adopted AT&T’s proposed construction, construing the term to mean “a connection that assures connection speed of at least approximately one megabit per second and, where applicable based on the type of application, packet loss requirements that are about 10-5 and latency requirements that are less than one second.”

The Federal Circuit began with the language of the claims. The district court found that “high quality of service connection” is a coined term that has no ordinary meaning in the industry, and the Federal Circuit agreed. Because the claim was silent as to what amount of quality is sufficient to be “high,” the Federal Circuit looked first to the specification, followed by the prosecution history, to determine the meaning of the term “high quality of service connection.”

The applicant of the ’119 patent relied on Figure 3 during prosecution to support an amendment that gave rise to the term “high quality of service connection.” Figure 3 indicates minimum requirements for connection speed, packet loss, and latency. During prosecution of the parent application, the applicant argued that “the various connection parameters illustrated for high quality of service enabled bandwidth applications in Fig. 3” supported the term “high quality of service connection.” The Federal Circuit found the applicant relied on the minimum connection parameter requirements described in Figure 3 to overcome the examiner’s §112 enablement rejection.

The Federal Circuit rejected the patent owner’s argument that the prosecution history was not relevant in the absence of clear disavowal, noting that any explanation, elaboration, or qualification presented by the inventor during patent examination is relevant, for the role of claim construction is to capture the scope of the actual invention that is disclosed, described, and patented. The Federal Circuit said that where there is no clear ordinary and customary meaning of a coined term of degree, it may look to the prosecution history for guidance without having to first find a clear and unmistakable disavowal.

The Federal Circuit also rejected the argument that statements made in response to an enablement rejection do not affect claim scope. Noting that the enablement requirement prevents claims broader than the disclosed invention.

The Federal Circuit affirmed the District Courts claim construction.

In Cobalt Boats, LLC v. Brunswick Corp., [2018-1376] (May 30, 2019), the Federal Circuit, in a NON-PRECEDENTIAL decision, the Federal Circuit reversed district court judgment of nearly $5.4 million for willful infringement of U.S. Patent No. 8,375,880 on a swim step for boats.

The claims at issue required a step “capable of being rotated 180° between a stored position . . . and a deployed position.” It was undisputed that the accused boat step did not rotate 180°. The Federal Circuit began with the fact that while the parties disagreed on the claim construction, the court did adopted the patent owner’s position, holding that the “180 degrees” limitation should be given its “plain and ordinary meaning” and rejecting Brunswick’s proposed construction. The Federal Circuit observed that it is not appropriate to leave to the jury the task of resolving claim construction disputes.

The Federal Circuit found that the “180 degrees” limitation required that the step be capable of rotating at least 180 degrees, not merely “flipping over” as the patent owner contended. The Federal Circuit said that where a precise value is included in the claim without a term such as “about,” it interprets the claim language as imposing a strict numerical boundary, absent evidence that such a construction would be inconsistent with the intrinsic evidence. The Federal Circuit said the claim does not use “about,” which suggests that 180 degrees serves as a precise numerical boundary for the minimum rotation of the step, and the intrinsic evidence did not suggest a different construction. The Federal Circuit construed the 180 degrees limitation to require that the swim step be capable of rotating at least 180 degrees, which meant that a step that can rotate at most 179 degrees would not meet the limitation, while a step that can rotate 181 degrees would.

The Federal Circuit rejected the argument that the 180 limitation way merely a way of saying the steps flipped, noting that the claims also said that the steps flipped, so such a construction would make the 180 limitation redundant.

Based upon its construction of the 180 degree limitation, the Federal Circuit concluded that there was no literal infringement. With respect to infringement under the doctrine of equivalents, the Federal Circuit found that the claims were limited by prosecution history estoppel since the 180 degree limitation was added to obtain allowance of the claims. The Federal Circuit rejected the patent owners argument that estoppel did not apply since the limitation was added to overcome prior art that only rotated 90°, noting that the scope of disclaimer is measured by the difference between the original and the amended claims, not the difference be-tween the amended claims and the prior art that was avoided through the amendment, this is particularly true where the claims are amended to include a specific numeric boundary.

Reversing the finding of literal infringement and infringement under the doctrine of equivalents, the Federal Circuit reversed.

This case highlights the importance of having some wiggle room on numeric limitations in claims. Also the opinion is non-precedential, the Federal Circuit cited several cases illustrating the importance of Wiggle words, such as “about.” Jeneric/Pentron, Inc. v. Dillon Co., 205 F.3d 1377, 1381 (Fed. Cir. 2000); Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995);and Elekta Instrument S.A. v. O.U.R. Scientific International, Inc., 214 F.3d 1302 (Fed. Cir. 2000).