In Baxalta Inc. v. Genentech, Inc., [2019-1527] (August 27, 2020), the Federal Circuit vacated the district court’s judgment of non-infringement of the asserted claims of U.S. Patent No. 7,033,590 because the district court erred in construing the terms “antibody” and “antibody fragment,” and remanded.

Generally, antibodies are Y-shaped structures comprising two heavy chains (H chains) and two light chains (L chains). Baxalta argued “antibody” should be construed as a molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains). Genentech argued “antibody” should instead be construed as an immunoglobulin molecule, having a specific amino acid sequence that only binds to the antigen that induced its synthesis or very similar antigens, consisting of two identical heavy chains (H chains) and two identical light chains (L chains).

The district court determined that the term antibody standing alone without other structural terms can have different meanings to those skilled in the art, and that both Baxalta’s and Genentech’s proposed constructions were acceptable definitions. However, the district adopted Genentech’s narrower definition based on an express definition in column 5 of the patent.

The Federal Circuit said that contrary to the district court’s construction, nothing in the plain language of claim 1 limits the term “antibody” to a specific antibody consisting of two identical heavy chains and two identical light chains or an antibody that only binds the antigen that induced its syn-thesis or very similar antigens. The dependent claims confirm that “antibody” is not so limited.

The Federal Circuit said that the district court’s construction which excludes explicitly claimed embodiments is inconsistent with the plain language of the claims. The district court rejected this inconsistency, suggesting that the proper result here is “invalidation of the inconsistent claims rather than an expansion of the independent claims.” The plain language of these dependent claims weighs heavily in favor of adopting Baxalta’s broader claim construction, and rejected the district court’s construction which renders dependent claims invalid.

As to the definition in the specification that the district court found limiting, the Federal Circuit said that when considered in the context of the remainder of the written description and the claims, it read the excerpt in column 5 as a generalized introduction to antibodies rather than as a definitional statement. The Federal Circuit also noted that these general statements do not include terms we have held to be limiting in other contexts such as “the present invention includes . . .” or “the present invention is . . .” or “all embodiments of the present invention are . . . .” The Federal Circuit further disagreed that the prosecution history supported the narrow construction, recognizing that that the prosecution history “often lacks the clarity of the specification and thus is less useful for claim construction purposes.”

The construction of antibody fragment followed the construction of antibody, and because the district court erred in construing the terms “antibody” and “antibody fragment” and entered judgment of non-infringement based on its erroneous constructions, the Federal Circuit vacated and remand for further proceedings consistent with the correct constructions of the terms.

In MCRO, Inc., v. Bandai Namco Games America Inc., [2019-1557] (May 20, 2020), the Federal Circuit affirmed summary judgment of noninfringement of U.S. Patent No. 6,611,278, and vacated judgment of invalidity because the specification fails to enable the full scope of the claims and remand for the district court to consider any appropriate further proceedings in light of, among other things, defendants’ offer to withdraw their invalidity counterclaims without prejudice.

With respect to the non-infringement determination, the Federal Circuit said that the district court was correct as a matter of law in ruling that a “vector,” in the context of the ’278 patent must have “3-D magnitude and direction computed by pure subtraction/addition between the neutral and target models, with one vector corresponding to each set of two vertices.” Because the parties agreed that there is no infringement under this construction, the Federal Circuit affirmed the district court’s grant of summary judgment of noninfringement.

The Federal Circuit said that the proper claim construction is based “not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.”  The Federal Circuit said that the only meaning that matters in claim construction is the meaning in the context of the patent.’” The Federal  Circuit said the specification compels the three-dimensional geometric construction of “vector” adopted by the district court. On the issue of validity, the Federal Circuit agreed that the defendants failed to identify with particularity any method of animation that falls within the scope of the claims that was not enabled. Without any specific examples, the district court’s reasoning is too abstract, too conclusory, to support summary judgment.  The Federal Circuit saw no reason to depart from its usual requirement that the challenger identify specifics that are or may be within the claim but are not enabled. Specifics have always mattered. A fuller set of fact-findings about what is within the scope of the claims is necessary to decide the enablement issue.

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.