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Beware Enablement of Genus Antibody Claims

by Jayita Guhaniyogi, PhD | Oct 5, 2023 | Patents

The US Court of Appeals for the Federal Circuit invalidated yet another set of antibody genus claims, finding the case “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v. Sanofi. The Federal Circuit concluded that patent claims covering a class of antibodies targeting functions of blood clotting factors were invalid for lack of enablement, echoing the reasoning followed by fellow Circuit Judge Dyk, who sat by designation in the district court. Baxalta Inc. and Baxalta GMBH v. Genentech, Inc., Case No. 2022-1461 (Fed. Cir. Sept. 20, 2023) (Moore, Clevenger, Chen, JJ.)

This case involves Baxalta’s patent covering antibody preparations that bind to blood clotting Factors IX/IXa and thereby increase the procoagulant activity of Factor IXa. This in turn activates another blood clotting factor, Factor X, that is useful to treat hemophilia, particularly in patients who develop inhibitors to blood clotting Factor VIII. The claim at issue recited “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases procoagulant activity of Factor IXa.”

Baxalta sued Genentech for infringement. In a prior appeal involving claim construction, the Federal Circuit vacated the district court’s grant of summary judgment of noninfringement and remanded for further proceedings. On remand, the district court granted Genentech’s motion for summary judgment for lack of enablement. Baxalta appealed.

Baxalta challenged the summary judgment of invalidity on enablement. Baxalta argued that a skilled artisan could make the full scope of the claimed antibodies without undue experimentation. With reference to the subject patent’s disclosure of using a prior art method known as the hybridoma technique for generating Factors IX/IXa antibodies, Baxalta argued that using routine screenings to find the antibodies exhibiting the claimed functions (i.e., those that bind Factors IX/IXa and increase procoagulant activity of Factor IXa) was within the skill of a skilled artisan without undue experimentation.

The Federal Circuit, citing Amgen, explained that the enablement standard under Section 112(a) requires that “the specification [] enable the full scope of the invention as defined by its claims,” allowing for “a reasonable amount of experimentation.” The Court explained that in Amgen, the patents at issue generically claimed all antibodies that bind to specific amino acid residues on a protein and blocked the protein from binding to LDL receptors. The Court observed that while the Amgen patent disclosed amino acid sequences of 26 antibodies, the claim scope could cover millions. Similarly, the Amgen patent disclosed a roadmap and another conservative substitution method for generating new antibodies and testing them for the claimed functions. In Amgen, the Supreme Court held that such methods were nothing more than “trial-and-error experimentation,” which, in the absence of “some general quality . . . running through the class that gives it a peculiar fitness for the particular purpose,” failed to enable the full scope in that case.

The Federal Circuit found the facts in this case “materially indistinguishable” from Amgen. Like the claims at issue in Amgen, Baxalta’s patent claims all [...]

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No Need To Be Explicit: Implicit Finding of Expectation of Success Is Sufficient

by Katherine Pappas | Oct 5, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability decision, finding that a combination of prior art references only requires an implicit indication of a reasonable expectation of success. Elekta Ltd. v. Zap Surgical Systems, Case No. 21-1985 (Fed. Cir. Sept. 21, 2023) (Reyna, Stoll, Stark JJ.)

Elekta owns a patent directed to a “method and apparatus for treatment by ionizing radiation.” The claimed invention uses a radiation source such as a linear accelerator (linac) mounted on concentric rings to deliver a beam of ionizing radiation to a target area on the patient. Zap challenged the patent as obvious in an inter partes review (IPR) proceeding. In its Final Written Decision, the Board agreed, concluding that a skilled artisan would have been motivated to combine the asserted prior art references. Elekta appealed.

Elekta raised three arguments on appeal:

The Board’s findings on motivation to combine were not supported by substantial evidence.
The Board failed to make any findings (explicit or implicit) on a reasonable expectation of success.
Even if the Board made such findings, they were not supported by substantial evidence.

The Federal Circuit first considered the issue of motivation to combine the prior art references disclosing radiation imagery with references disclosing radiation therapy, noting that the obviousness determination does not always require the prior art to expressly state a motivation for every obviousness combination. Elekta had challenged the asserted combination based on a physical impracticality in combining the art due to the weight of the linac. The Board, however, disagreed largely because of the level of skill in the art in addition to its definition of the relevant field as one that “includes the engineering design of sturdy mechanical apparatuses capable of rotationally manipulating heavy devices.” The Court found that the Board’s finding of motivation to combine was supported by substantial evidence, including the prosecution history, the prior art teaching and the expert testimony of record.

The Federal Circuit next considered Elekta’s argument that the Board erred by failing to articulate findings on reasonable expectation of success. The Court explained that “an obviousness determination requires finding that a person of ordinary skill in the art would have had a reasonable expectation of success,” referring to “the likelihood of success in combining references to meet the limitations of the claimed invention.” The Court concluded, however, that unlike the motivation to combine determination, which must be an explicit analysis under KSR, a finding of reasonable expectation of success may be implicit. The Court acknowledged that this could be seen as being in tension with its review of Board determinations under the Administrative Procedure Act but concluded that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including . . . those [regarding] a motivation to combine.”

Finally, the Federal Circuit addressed Elekta’s argument that, even if the Board made an implicit finding on reasonable expectation of [...]

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Chilly Adventures: Design Patent Prior Art Comparison Applies to Article of Manufacture

by Amol Parikh | Sep 28, 2023 | Patents

Addressing a matter of first impression concerning the scope of prior art relevant to a design patent infringement analysis, the US Court of Appeals for the Federal Circuit concluded that “to qualify as comparison prior art, the prior-art design must be applied to the article of manufacture identified in the claim.” Columbia Sportswear North America, Inc. v. Seirus Innovative Accessories, Inc., Case Nos. 21-2299; -2338 (Fed. Cir. Sept. 15, 2023) (Prost, Reyna, Hughes, JJ.)

Columbia owns a design patent that covers an ornamental design of a heat reflective material. Seirus markets and sells products (e.g., gloves) made with material that it calls HeatWave. An image of Columbia’s patented design and Seirus’s HeatWave material appear below:

Columbia Patented Design

Seirus HeatWave

Columbia sued Seirus for infringement. After the district court granted summary judgment of infringement, Seirus appealed to the Federal Circuit. The Court issued its decision in Columbia I, concluding that the district court improperly declined to consider the effect of Seirus’s logo in its infringement analysis and resolved certain issues that should have been left to the jury. The Court therefore vacated summary judgment and remanded for further proceedings.

On remand, the district court held a trial. Before trial, the district court limited admissible comparison prior art to “wave patterns of fabric,” declined to instruct the jury that “prior art” referred to prior designs of the claimed article of manufacture, and declined to instruct the jury that it did not need to find that any purchasers were deceived or that there was any actual or likelihood of confusion among consumers in the marketplace. Seirus was permitted to admit three prior art references that disclosed fabric, and Columbia was precluded from distinguishing the references by arguing that they did not disclose heat reflective material. The jury returned a verdict of noninfringement. Columbia appealed.

Among other things, Columbia challenged the exclusion of evidence and jury instructions concerning comparison prior art, and the jury instructions implicating Seirus’s logo.

The Federal Circuit began by discussing the appropriate prior art comparison in the context of design patent infringement. Citing its 2008 en banc decision in Egyptian Goddess v. Swisa, the Court explained that under the ordinary-observer test governing design patent infringement, prior art can help highlight distinctions and similarities between the claims and the accused design. For instance, when a claimed design is close to a prior art design, small differences between the accused design and the claim design are likely to be important. Conversely, if an accused design copied a particular feature of the claimed design that departs from the prior art, the accused design is likely to be regarded as deceptively similar to the claimed design, and thus infringing.

The question of first impression before the Federal Circuit was the proper scope of comparison prior art that may be [...]

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Hit Rewind: Analogous Art and Field of Endeavor

by Tessa Kroll | Sep 21, 2023 | Patents

Addressing the Patent Trial & Appeal Board’s application of the field of endeavor and reasonably pertinent tests for determining analogous art, the US Court of Appeals for the Federal Circuit found that the Board should not have required a petitioner to precisely articulate the relevant field of endeavor for the patent and prior art using the magic words, “field of endeavor.” However, the Court agreed with the Board that the prior art was not reasonably pertinent because it concerned a different problem than the challenge addressed by the patent. Netflix, Inc. v. DivX, LLC, Case No. 22-1138 (Fed. Cir. Sept. 11, 2023) (Stoll, Hughes, and Stark, JJ.)

Netflix filed an inter partes review (IPR) challenging DivX’s patent directed toward a feature called “trick play functionality,” which refers to the ability to fast forward, rewind and skip frames in a multimedia file. The patent’s background explains that the invention generally relates to the “encoding, transmission and decoding of multimedia files.” Notably, the claimed invention implements a multimedia file based on the Audio Video Interleave (AVI) structure with an additional storage structure called an “index chunk.”

In its petition, Netflix asserted that the challenged claims were obvious over two prior art references, Zetts in view of Kaku. Kaku disclosed the use of an AVI file with an index chunk to show image data and/or play sound data in a digital camera. Kaku explained that the invention’s primary object is to reproduce a motion image in a device with minimal memory but clarified that the invention is “applicable to every electronic appliance to reproduce motion images.” Netflix asserted that Zetts disclosed a system for facilitating trick play while Kaku disclosed using an AVI file format with an index chunk to store video/audio data.

In its patent owner response, DivX argued that Kaku was non-analogous art because the challenged patent relates to facilitating trick play in streamed multimedia content, whereas Kaku utilizes M-JPEG files in limited-memory cameras. DivX similarly argued that Kaku was not reasonably pertinent to the problem of “facilitating trick play functionality in streaming services.” Netflix countered that Kaku must be considered for its AVI teachings and/or the “encoding and decoding of multimedia files,” both of which are “applicable to every electronic appliance to reproduce motion images” and render Kaku reasonably pertinent. The Board rejected Netflix’s obviousness argument, holding that it failed to identify the field of endeavor for the DivX patent or Kaku, as well as the problem to be addressed by the DivX patent. Netflix appealed.

The Federal Circuit first considered the Board’s conclusion that Netflix failed to identify an overlapping field of endeavor for Kaku and the DivX patent. The Court explained that the field of endeavor is determined by reference to explanations of the invention’s subject matter in the specification and is not limited to the specific point of novelty or the particular focus within a field. Rather, a field of endeavor may be broadly defined because it relies on the specification’s complete disclosure. Applying this principle, the [...]

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Less Is More: IPR Claim Amendments May Not Enlarge Claim Scope

by Amol Parikh | Sep 14, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a decision from the Patent Trial & Appeal Board denying a motion to amend claims during an inter partes review (IPR) proceeding, explaining that a claim amendment is improper if a proposed claim is broader in any respect relative to the original claims, even if it is overall narrower. Sisvel International S.A. v. Sierra Wireless, Inc., et al., Case Nos. 22-1387; -1492 (Fed. Cir. Sept. 1, 2023) (Prost, Reyna, Stark, JJ.)

Sisvel owns two patents directed to methods and apparatuses that rely on the exchange of frequency information in connection with cell reselection between a mobile station (or user cell phone) and a central mobile switching center. Sierra Wireless filed petitions for IPR alleging that claims of Sisvel’s patents were unpatentable as anticipated and/or obvious in view of certain prior art. During the IPR proceeding, the Board determined that the claim term “connection rejection message” should be given its plain and ordinary meaning of “a message that rejects a connection.”

The Board also denied Sisvel’s motion to amend the claims of one of the patents, finding that the amendments would have impermissibly enlarged the claim scope. the Board focused on a limitation relating to “setting a value,” comparing the original claims’ requirement with that of the proposed substitute claims. The original claims required that the value be set “based at least in part on information in at least one frequency parameter” of the connection rejection message while the substitute claims recited that the value may be set merely by “using the frequency parameter” contained within the connection rejection message. The Boeasoneasoned that in the proposed substitute claim, the value that is set need not be based on information in the connection rejection message, and thus the claim was broader in this respect than the original claims. After denying the motion to amend, the Board concluded that the original claims were unpatentable. Sisvel appealed.

Sisvel challenged the Board’s construction of “connection rejection message,” arguing that the term should be limited to a message from the specific cellular networks disclosed in the specification. The Federal Circuit rejected Sisvel’s argument, finding that the intrinsic evidence provided no persuasive basis to limit the claims to any particular cellular network disclosure. Having agreed with the Board’s construction, the Court affirmed the unpatentability determination.

Sisvel also challenged the Board’s refusal to permit Sisvel to amend the claims. Sisvel argued that the Board had incorrectly found that the proposed substitute claims were broader than the original claims because when all the limitations were considered as a whole, the scope of the substitute claims was narrower than the original claims.

Citing 35 U.S.C. § 316(d)(3), the Federal Circuit noted that when a patent owner seeks to amend its claims during an IPR, the amended claims “may not enlarge the scope of the claims of the patent.” The Court explained that removal of a claim requirement can broaden the resulting amended claim and concluded that such was the case [...]

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Sins of the Fathers? Grandparent IPR Factors into Current Institution Decision

by Kyle Sorenson, PhD | Sep 7, 2023 | America Invents Act, Patents

US Patent & Trademark Office (PTO) Director Kathi Vidal vacated and remanded a Patent Trial & Appeal Board decision denying institution of an inter partes review (IPR) because the Board improperly applied the precedential Advanced Bionics framework in rendering its decision. Keysight Tech., Inc. v. Centripetal Networks, Inc., IPR2022-01421 (PTAB Decision Review Aug. 24, 2023) (Vidal, Dir.)

Keysight Tech. petitioned for an IPR proceeding against a patent owned by Centripetal Networks, challenging the validity of all claims. After the Board denied institution, Director Vidal issued a sua sponte director review decision, vacating and remanding the Board’s decision.

The Centripetal patent is the great-grandchild of, and shares the same disclosure as, an earlier Centripetal patent that was subject to an IPR proceeding during the pendency of the presently challenged patent. The Final Written Decision (FWD) in the earlier IPR found all claims of the patent unpatentable. The patent owner included that FWD in an Information Disclosure Statement (IDS) submitted during the prosecution of the presently challenged patent, and the examiner initialed it as having been considered.

In its decision denying institution, the Board cited the guidance of Advanced Bionics, which articulates a framework that requires that the Board determine the following:

Whether the same or substantially the same prior art or arguments made in the petition were previously presented to the PTO during prosecution of the challenged patent
Whether the PTO erred in a manner material to the patentability of the challenged claims when it allowed the claims of the patent.

If both factors are met in the affirmative, the Board should not exercise its discretion to deny institution.

Here, the Board found that the first factor of the Advanced Bionics framework was met because the petitioner’s arguments in its petition were the same or substantially the same as those in the FWD in the IPR of the grandparent patent. However, the Board found that the second part of the framework was not satisfied and therefore denied institution.

Although Director Vidal agreed with the Board’s findings under the first factor, she vacated the Board’s findings pursuant to the second factor after determining that this factor was also met. Director Vidal found that the PTO erred in a manner material to the patentability of the challenged claims for the following reasons:

The challenged patent and the grandparent were directed to the same subject matter.
The prior art references submitted to the PTO during the prosecution of the challenged patent were the same as those asserted in earlier IPR and were considered by the examiner through the patent owner’s IDS.
In the grandparent IPR, the Board held all of the claims of the patent unpatentable due to these same prior art references.
The examiner’s statement of reasons for allowing the challenged patent was that the claims were directed to limitations that appeared in both the currently challenged claims and the claims found unpatentable in the grandparent patent.

As the director noted, the overlap between the claim limitations in the [...]

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The End Is Not So Near: Patent Term Adjustments Count in Obviousness-Type Double Patenting Determinations

by Jake B. Vallen | Sep 7, 2023 | Patents

Addressing for the first time how patent term adjustments (PTAs) interact with obviousness-type double patenting (ODP), the US Court of Appeals for the Federal Circuit concluded that when members of a patent family have different expiration dates due to PTAs, the earlier expiring family members can be used as a basis for an ODP invalidity challenge against the later expiring family members. In re Cellect, LLC, Case Nos. 2022-1293; -1294; -1295; -1296 (Fed. Cir. Aug. 28, 2023) (Lourie, Dyk, Reyna, JJ.)

Cellect owns several patents directed to devices with image sensors, such as personal digital assistant devices and phones. Each patent claims priority from a single application. None of the patents were subject to a terminal disclaimer, and each was granted PTA under 35 U.S.C. § 154(b) because of PTO delay during prosecution. Had the patents not been granted PTA, each one would have expired on the same date as the original application.

After Cellect sued for infringement, the defendant requested ex parte reexaminations and asserted that the patents were unpatentable based on ODP. During the reexaminations, the Examiner “determin[ed] that the challenged claims were obvious variants of Cellect’s prior-expiring reference patent claims” because “although the ODP invalidating reference patents form a network across the four ex parte reexamination proceedings, all invalidated claims can be traced back to the single family member [now expired] patent that did not receive a grant of PTA.” The Patent Trial & Appeal Board affirmed the Examiner’s finding. Cellect appealed.

The Federal Circuit began with the inquiry for determining unpatentability based on ODP and whether, in that context, a patent’s expiration date includes a duly granted PTA under 35 U.S.C. § 154. While the Court recognized that the relevant expiration date for an ODP analysis where a patent received a patent term extension (PTE) is the pre-PTE expiration date, the Court concluded that, in the context of patents that have received PTAs, the relevant expiration date for analyzing ODP is the expiration date accounting for the PTA regardless of whether a terminal disclaimer has been filed. The Court reasoned that when determining whether claims are unpatentable for ODP, PTA and PTE, they “should be treated differently” because each is governed by different statutes that were designed to address different circumstances. While both PTAs and PTEs were intended to recover lost patent terms, PTAs were designed to extend patent terms because of administrative delays in patent processing and preclude the extension of a patent term past a terminal disclaimer. PTEs were designed to extend a patent term because of regulatory delays in product approval and are not foreclosed by a terminal disclaimer. As such, the Court reasoned that not contemplating a PTA when analyzing ODP would “frustrate the clear intent of Congress” because “when a terminal disclaimer has been entered in a patent subject to PTA, no patent (or claim) may be extended beyond the disclaimed expiration date.”

The Federal Circuit next considered whether examiners are required to consider “equitable concerns” such as good faith when [...]

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Don’t Be So Stern: Copying Carries Significant Weight in Assessing Objective Evidence

by Amol Parikh | Aug 31, 2023 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision invalidating a patent, finding that the Board erred in assessing nexus and weight to be accorded to objective evidence of nonobviousness. Volvo Penta of the Americas, LLC v. Brunswick Corp., Case No. 22-1765 (Fed. Cir. Aug. 24, 2023) (Moore, Lourie, Cunningham, JJ.)

Volvo Penta owns a patent directed to a tractor-type stern drive for a boat. A stern drive is a type of engine that is mounted in the hull of a boat and connected to a drive unit mounted outside of the hull, typically on the stern. In the industry, this arrangement is often referred to as an inboard/outboard drive. In 2015, Volvo Penta launched its commercial embodiment of the patent called the Forward Drive and was popular particularly for wake surfing and other water sports. The Forward Drive included forward-facing propellers that increased the distance between the propeller and swimmers or surfers compared to prior pulling-type stern drive boats.

In August 2020, Brunswick launched its own drive, the Bravo Four S, which embodies Volvo Penta’s patent. On that same day, Brunswick filed a petition for inter partes review asserting that the challenged claims were anticipated or obvious based on several references, two of which were Kiekhaefer and Brandt. In response, Volvo Penta argued that a person of ordinary skill in the art would not have been motivated to combine Kiekhaefer and Brandt with a reasonable expectation of success and that the objective indicia of nonobviousness overcame any prima facie case of obviousness. In support, Volvo Penta offered evidence of copying, industry praise, commercial success, skepticism, failure of others and long-felt but unsolved need. Volvo Penta also argued that it was entitled to a presumption of nexus between the objective indicia and the claimed invention, and, even if there was no presumption, there was still nexus.

The Board found that Kiekhaefer did not anticipate the challenged claims, but it would have been obvious to redesign the stern drive of Brandt in light of Kiekhaefer’s outboard motor to arrive at the challenged claims. After finding a motivation to combine (and prima facie obviousness), the Board turned to Volvo Penta’s objective evidence of nonobviousness. The Board first determined that Volvo Penta was not entitled to a presumption of nexus because, even though the Forward Drive and Bravo Four S indisputably embody the challenged claims, Volvo Penta did not make sufficient arguments on coextensiveness. The Board also found that regardless of the presumption, Volvo Penta did not otherwise show nexus because it failed to identify the “unique characteristics” or “merits” of the claimed invention.

Despite finding no nexus, the Board still analyzed the objective evidence and concluded that Volvo Penta’s objective evidence weighed somewhat in favor of nonobviousness but that Brunswick’s strong evidence of obviousness outweighed the objective evidence. The Board therefore concluded that the challenged claims were unpatentable. Volvo Penta appealed.

Volvo Penta raised three primary arguments on appeal:

The Board’s [...]

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No Two Ways About It: No Disparagement ≠ Teaching Away, Free Samples ≠ Commercial Success

by Mike Baldwin | Aug 31, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board invalidating two patents: one as anticipated because disclosure of a genus anticipated the claimed species, and the other as obvious because the prior art did not disparage the claimed invention and therefore was not a “teaching away.” The Court also found that free samples cannot be used to show commercial success. Incept LLC v. Palette Life Sciences, Inc., Case Nos. 21-2063; -2065 (Fed. Cir. Aug. 16, 2023) (Schall, Taranto, JJ.) (Newman, J., concurring in part, dissenting in part).

Incept owns two patents related to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation-targeted tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette filed inter partes review petitions against each patent, asserting that the claims of one patent were anticipated and the claims of the other were obvious. Both theories of invalidity relied on the same prior art reference, Wallace. The Board instituted review and ultimately found both patents unpatentable. Incept appealed.

As to the patent that the Board found anticipated, Incept argued that the Board erred legally by “picking and choosing” from the teachings of Wallace to piece together elements. Incept argued that Wallace teaches a genus of millions to billions of possible compositions while its patent claims a species. Thus, according to Incept, the genus had to be defined well enough that a person of ordinary skill could have envisioned each member of the genus.

The Federal Circuit found no legal error in the Board’s anticipation analysis. The Court rejected Incept’s assertion that its patent claimed a species, finding that the patent described a method to inject a composition that had the same general properties as the composition described in Wallace. The Court also found that the Board’s conclusion that Wallace taught biodegradable compositions (where Wallace stated that “a portion of the polymer may be biodegradable”) was supported by substantial evidence and noted that it was not the Court’s duty to reweigh factual determinations.

As to the Board’s obviousness finding of the other patent, Incept alleged that the Board improperly reiterated its anticipation analysis, disregarded statements in Wallace that teach away, did not separately analyze the dependent claims and disregarded evidence of commercial success. The Court was unpersuaded by any of these arguments.

First, the Federal Circuit noted that since the anticipation analysis had no error, it was not improper for the Board to rely upon that analysis for its obviousness determination. The Court noted that the Board relied on the teachings of another piece of prior art concerning the challenged patent’s displacement limitation. The Court also dismissed Incept’s allegation that the motivation to combine analysis was conclusory.

The Federal Circuit rejected Incept’s assertion that Wallace taught away from biodegradable compositions, noting that Wallace provided a preference for an alternative but did not criticize, discredit or [...]

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Petitioner Reply May Include New Evidence if Responsive to Patent Owner and Based on Original Legal Contentions

by Tessa Kroll | Aug 24, 2023 | Patents

Addressing the issue of new invalidity theories offered during inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit held that a petitioner does not improperly offer new theories when it merely expands on previously raised arguments and responds to a patent owner’s assertions without advancing a “meaningfully distinct [invalidity] contention.” Rembrandt Diagnostics, LP v. Alere, Inc., Case No. 21-1796 (Fed. Cir. Aug. 11, 2023) (Moore, C.J.; Reyna, Dyk, JJ.) The Court further concluded that the patent owner waived its new theories argument by raising a general objection that did not identify which theories were allegedly new.

Alere filed an IPR petition challenging a Rembrandt patent directed to test assay devices and methods for testing biological fluids. Alere argued that the claims were obvious over two combinations of prior art references (among other grounds not at issue on appeal): MacKay in view of Charm or May, and Tydings in view of MacKay or Lee-Own. On remand from a previous appeal, the Patent Trial & Appeal Board ordered briefings on all non-instituted grounds set forth in Alere’s petition. Rembrandt filed a patent owner response without an expert declaration. Alere filed a reply attaching a declaration from its expert and responding to arguments raised by Rembrandt in its response and by the Board in its institution decision.

In a sur-reply, Rembrandt generally argued that Alere “resort[ed] to new theories in reply” but did not specifically contest the two combinations at issue while specifically objecting to other allegedly new theories. Relying on Alere’s expert testimony, the Board issued a final written decision finding the claims at issue unpatentable over the MacKay and Tydings combinations. Rembrandt unsuccessfully petitioned for Director rehearing and then appealed the decision, arguing that the Board abused its discretion by relying on Alere’s new theories and evidence and that there was a dearth of substantial evidence to support the Board’s determinations.

The Federal Circuit first considered whether Rembrandt had forfeited its new theories argument by raising a general objection without expressly objecting to the obviousness grounds at issue. Underscoring the fact that Rembrandt had specifically identified and objected to other allegedly new theories, the Court concluded that Rembrandt’s general objection was insufficient and that Rembrandt’s “objection” argument had been forfeited. The Court noted that holding otherwise would be unfair to the parties and the Board because such a general objection could not provide adequate notice.

Even though Rembrandt’s new theories argument had been waived, the Federal Circuit concluded that Alere’s reply arguments did not constitute new theories and evidence. As the Court noted, in its reply a petitioner must identify “with particularity . . . the evidence that supports the grounds for each challenge to each claim” and may “only respond to arguments raised in the corresponding opposition, . . . patent owner response, or decision on institution.” The Court further explained that a petitioner who asserts previously unidentified prior art disclosures or embodiments in its reply to make a “meaningfully distinct contention” impermissibly raises a [...]

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