anticipation Archives

anticipation

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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Holy Pulmonary Hypertension, Batman: Method of Treatment Not Constrained by Safety and Efficacy

by Nitya Anand | Aug 3, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit also affirmed the district court’s holding that certain claims of the product-by-process patent were invalid because the claimed product was in the prior art, regardless of the process by which it was made. United Therapeutics Corporation v. Liquidia Technologies, Inc., Case Nos. 22-2217; 23-1021 (Fed. Cir. July 24, 2023) (Lourie, Dyk, Stoll, JJ.)

United Therapeutics is the maker of Tyvaso®, a treprostinil formulation approved for treating pulmonary hypertension. United Therapeutics asserted two patents covering Tyvaso® against Liquidia’s § 505(b)(2) new drug application (NDA) on Yutrepia™. One patent was a method of treatment patent claiming to treat pulmonary hypertension by administering a “therapeutically effective” dose of a treprostinil formulation, and the other was a product-by-process patent claiming a treprostinil composition with lowered levels of impurities made by a specific salt formation process.

The district court found that United Therapeutics showed that a single administration of treprostinil improves a patient’s hemodynamics, establishing that administration of Liquidia’s Yutrepia, comprising treprostinil, would directly infringe the method of treatment claims. The district court also concluded that even though Yutrepia’s label did not provide hemodynamic data, the label’s instructions would inevitably lead to the administration of a therapeutically effective single event dose. The court thus concluded that Liquidia would induce infringement of the method of treatment claims.

The district court further found that the asserted claims were not invalid for lack of enablement or written description. The court reasoned that a skilled artisan would not need to engage in undue experimentation to practice the full scope of the claimed treatment of pulmonary hypertension, despite potential safety concerns in treating certain patients, since the claims did not require safety and efficacy. The court found that the claims were not invalid for lack of written description, finding that a skilled artisan would, based on the specification, understand that treprostinil would effectively vasodilate the pulmonary vasculature, improve hemodynamics and treat a patient’s elevated pulmonary blood pressure.

Liquidia appealed on five issues: claim construction of the term “treating pulmonary hypertension,” enablement, written description, induced infringement and infringement of the product by process claims. United Therapeutics cross-appealed on anticipation of the product by process claims and non-infringement of those claims.

First, regarding the construction of “treating pulmonary hypertension,” the Federal Circuit affirmed that the term encompassed all recognized groups of pulmonary hypertension but noted that the claim language “treating pulmonary hypertension” did not import any additional efficacy limitations or safety limitations, even those in a group that would not benefit from the treatment. The Court declined to read any safety or efficacy requirements into the claims, explaining that absent incorporation into the claims, the safety and efficacy of a claimed treatment are the purview of the US Food & Drug Administration (FDA), not patent law.

Regarding enablement and written description, Liquidia argued that the method [...]

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If Prior Art Discloses Ingredients and How to Mix Them, the “Cake” Is Anticipated

by Kyle Sorenson, PhD | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed that challenged claims were invalid as anticipated based on principles of inherency where the disclosed prior art formulations and processes necessarily met a disputed claim limitation. Arbutus Biopharma Corp. v. ModernaTx, Inc., Case No. 20-1183 (Fed. Cir. April 11, 2023) (Reyna, Schall, Chen, JJ.)

Arbutus Biopharma owns a patent that matured from an application filed on March 9, 2015, that claims priority to a provisional application filed on June 30, 2010. The claimed invention provides stable nucleic acid-lipid particle (SNALP) formulations with a non-lamellar structure that function to increase the efficiency of nucleic acid entry into cells to promote the downregulation of gene expression. The non-lamellar morphology of a SNALP formulation was known to depend on two factors: the lipids incorporated into the SNALP formulation, and the process used to form the SNALPs. The patent disclosed five SNALP formulations of various compositions that can be used and incorporated by reference two US patent publications, which describe two methods that can be used to make SNALP formulations: the Direct Dilution Method (DDM) and the Stepwise Dilution Method (SDM). The representative independent claim recites a composition of SNALPs, wherein each particle in the plurality of SNALP particles comprises a nucleic acid and various lipid types. The claim also requires that at least 95% of the particles in the plurality of particles have a non-lamellar morphology (the Morphology Limitation).

Moderna filed a petition for inter partes review (IPR) asserting that all the claims of the Arbutus patent were anticipated by a prior art patent. The Patent Trial & Appeal Board found that although the Morphology Limitation was not expressly found in the prior art, the claims were anticipated. The Board determined that the Morphology Limitation was an inherent property (or natural result) of the prior art disclosures. On appeal, Arbutus challenged the Board’s inherent and express anticipation findings for many of the challenged claims, including for the Morphology Limitation.

A limitation is inherent if it is the natural result flowing from the prior art’s explicit disclosure. In other words, a limitation is inherent when the limitation is a property necessarily present in the invention and not actually an additional requirement imposed by the claims. In the IPR proceeding, Moderna argued that the Morphology Limitation was inherent because one skilled in the art would necessarily obtain formulations meeting this limitation by making formulations using the five formulations disclosed by the patent and using the DDM method (from the incorporated-by-reference disclosures) to prepare the formulations.

Both the challenged patent and the prior art disclosed five formulations that can be used to obtain the SNALP formulations. Evidence showed that any differences between the formulations disclosed in these patents would not impact the Morphology Limitation. The Federal Circuit found that substantial evidence supported a finding that the formulations disclosed in both the challenged patent and the prior art were the same or essentially the same.

The Federal Circuit further explained that both the challenged patent and the [...]

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Overlapping Ranges in Prior Art Put Burden on Patentee to Show Criticality

by Alexandra Cavazos, PhD | Apr 20, 2023 | Patents

The US Court of Appeals for the Federal Circuit found that the challenged patents were invalid as anticipated and obvious in a case involving claimed ranges and prior art that included teachings with overlapping ranges. UCB, Inc. v. Actavis Laboratories UT, Inc., Case No. 21-1924 (Fed. Cir. Apr. 12, 2023) (Moore, C.J.; Chen, Stoll, JJ.)

UCB owns two prior art patents (the Mueller patents), one directed to methods for stabilizing rotigotine that covers a drug used in UCB’s Neupro® transdermal patches to treat Parkinson’s disease, and the other directed to the stable dispersions of rotigotine used in Neupro® transdermal patches.

Soon after UCB began marketing its original Neupro® transdermal patch in 2007, it discovered that rotigotine crystallized when the patch was kept at room temperature, which lowered the amount of rotigotine available to cross the skin/blood barrier and enter the patient’s circulation and reduced the product’s effectiveness. UCB recalled Neupro® from the market in the United States. In Europe, it marketed Neupro® only under “cold chain” conditions, which reduced the rotigotine crystallization.

The challenged patent in this case solved the problem of room temperature crystallization using dispersions in which the ratio of rotigotine to the stabilizer polyvinylpyrrolidone (PVP) ranged from “about 9.4 to about 9.6.” The original Neupro® formulation had a rotigotine to PVP ratio of 9:2, and the Mueller patents disclosed a partially overlapping range of 9:1.5 to 9:5, as shown in the following graphic from the Federal Circuit’s opinion:

The reformulated Neupro had a ratio of 9:4 rotigotine to PVP and exhibited stability for up to two years at room temperature.

The district court held that the Mueller patents anticipated all asserted claims because a person of ordinary skill in the art (POSA) would “readily envisage” a combination of 9% rotigotine with 4% to 5% of PVP. The district court also determined that all claims were obvious in light of the Mueller patents and other prior art.

Anticipation/Overlapping Ranges

The Federal Circuit first noted that although the prior art that discloses a point within a claimed range generally anticipates that claim, such was not the case here, and the district court committed legal error treating it thus.

Instead, the Federal Circuit treated this case as one of overlapping ranges. Under that legal rubric, once a patent challenger establishes a prima facie case of anticipation by showing that the claimed range partially overlaps with the cited art, the burden shifts to the patentee to show that the “claimed range is critical to the operability of the claimed invention.” The Court stopped short of ruling that UCB had not met its burden of showing the criticality of the range because it concluded that the two patents in question were obvious in light of the overlap between the claimed ranges and those of the Mueller patents.

Teaching Away

The Federal Circuit affirmed the district court’s rejection of UCB’s arguments that Tang, another [...]

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Disclaiming Claim Scope: Could the Patentee Have Anticipated This?

by Jake B. Vallen | Apr 6, 2023 | Patents

In the most recent decision in the Apple/VirnetX saga, the US Court of Appeals for the Federal Circuit affirmed a remand ruling from the Patent Trial & Appeal Board finding the challenged claims of VirnetX’s patents unpatentable. VirnetX Inc. v. Mangrove Partners Master Fund, Ltd., Case No. 2020-2271 (Fed. Cir. Mar. 30, 2023) (Moore, C.J.; Hughes, Stark, JJ.) (nonprecedential).

VirnetX owns two patents relating to a “secure mechanism for communicating over the internet.” The patents relate to a system in which a DNS module “intercepts . . . and determines whether [a] request is for a secure site.” The system creates a VPN if the proxy determines that the request is for a secure site. If the proxy determines that the request is not for a secure site, it forwards the request to a conventional DNS.

Mangrove, Apple and Black Swamp (collectively, Mangrove) petitioned for inter partes review (IPR) challenging various claims of the patents. The Board found that all the challenged claims were unpatentable as anticipated by Kiuchi or obvious in view of Kiuchi and other references. VirnetX appealed to the Federal Circuit (Mangrove Appeal). In that appeal, the Federal Circuit determined that, contrary to the Board’s finding, when VirnetX distinguished Aventail during reexamination of one of the patents, VirnetX disclaimed “a system in which a client computer communicates with an intermediate server via a singular, point-to-point connection.” As a consequence of the prosecution disclaimer, the Court found that the claims “require[s] direct communication between the client and target computers.” The Court vacated the Board’s decision and remanded the case for the Board to determine further factual questions regarding Kiuchi because “substantial evidence does not support the Board’s finding that the C-HTTP name server of Kiuchi performs the functions of the claimed DNS proxy module.”

Following the Mangrove Appeal, the Board again found that Kiuchi—the only prior art reference at issue in the present appeal—discloses a “secure network” for the transfer of patient information in a hospital setting and teaches a “direct-communication VPN between the client and target.” As a result, the Board concluded that Kiuchi anticipates all the challenged claims. VirnetX again appealed.

The Federal Circuit first addressed the Board’s conclusion that “Kiuchi teaches a direct-communication VPN and is therefore within the scope of the claims of VirnetX’s … patent, and not an indirect-communication VPN, which would have brought Kiuchi within the scope of VirnetX’s disclaimer.” The Court agreed with the Board that “Kiuchi discloses direct communication that satisfies the claimed VPN.” Specifically, “Kiuchi’s user agent does not communicate with the client-side proxy using a singular, point-to-point connection because the user agent addresses the desired endpoint, and the VPN provides the required message routing for the user agent to receive a response from the desired endpoint.” Moreover, the Court reasoned that Kiuchi’s proxy servers forward data packets and that Kiuchi teaches “the ability to address data to a particular computer,” consistent with the scope of the claims.

Next, the Federal Circuit addressed the Board’s [...]

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No First Place Trophy Here: Public Demo at Trade Show Found Invalidating

by Amol Parikh | Feb 23, 2023 | America Invents Act, Patents

Addressing the public use bar of pre-America-Invents-Act (AIA) 35 U.S.C. § 102(b), the US Court of Appeals for the Federal Circuit affirmed a district court’s decision to invalidate a patent because the patent owner’s disclosure of a prior art device at a trade show more than one year before the patent’s priority date was an invalidating prior public use. Minerva Surgical, Inc. v. Hologic, Inc., Case No. 21-2246 (Fed. Cir. Feb. 15, 2023) (Prost, Reyna, Stoll, JJ.)

Minerva sued Hologic for infringement of a patent directed to surgical devices for a procedure called endometrial ablation, which stops or reduces abnormal uterine bleeding. The patent had a priority date of November 7, 2011, and the asserted claim included the term “the inner and outer elements have substantially dissimilar material properties” (SDMP term). The district court construed the SDMP term to mean that the “inner and outer frame elements have different thickness and different composition.”

On completion of discovery, Hologic moved for summary judgment of invalidity, arguing that the asserted patent claims were anticipated under the public use bar of pre-AIA § 102(b). According to Hologic, more than a year before the patent’s priority date, Minerva brought a device called Aurora to the 38th Global Congress of Minimally Invasive Gynecology sponsored by the American Association of Gynecologic Laparoscopists (AAGL 2009)—an event dubbed the “Super Bowl of the industry.” During the AAGL 2009 conference, Minerva had a booth with 15 fully functional Aurora devices, gave a presentation discussing the Aurora devices and distributed brochures. In light of the record, the district court granted summary judgment that the asserted claims were anticipated under the public use bar. Minerva appealed.

Minerva raised three arguments on appeal. First, Minerva argued that disclosure of the Aurora device at AAGL 2009 was not a “public use” because Minerva “merely displayed” the device. Second, Minerva argued that there was no disclosure of the “invention” of the asserted claim because the Aurora device disclosed at AAGL 2009 lacked the SDMP term. Third, Minerva argued that the invention was not “ready for patenting” because Minerva was still improving the SDMP technology at the time of AAGL 2009, so the device did not function for its intended purpose of ablating “live human” tissue. The Federal Circuit addressed each argument in turn.

The Federal Circuit found that the district court had correctly determined that the Aurora device at AAGL 2009 was a “public use” since it was shown to individuals other than the inventor under no limitation, restriction or obligation of confidentiality. The undisputed record showed that Minerva pitched the Aurora device to various sophisticated industry members, who were allowed, without confidentiality obligations, to scrutinize the Aurora device closely enough to recognize and understand the SDMP technology Minerva later sought to patent.

The Federal Circuit also concluded that the Aurora device disclosed the SDMP term. The Court found that the inventors conceived of the SDMP technology before AAGL 2009 and that documentation about the Aurora device from before and shortly after the event [...]

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Tag, You’re It: Sanctions Award Must Reflect Violative Conduct

by Lillian Spetrino | Dec 22, 2022 | Patents

The US Court of Appeals for the Federal Circuit determined that an accused infringer was entitled to a new trial relating to validity issues but still faced sanctions for its continuous disregard of its discovery obligations. ADASA Inc. v. Avery Dennison Corp., Case No. 22-1092 (Fed. Cir. Dec. 16, 2022) (Moore, Hughes, Stark, JJ.)

ADASA owns a patent relating to methods and systems for commissioning radio-frequency identification (RFID) transponders. ADASA sued Avery Dennison for patent infringement, alleging that its manufacture and sale of certain RFID tags infringed ADASA’s patent. Both parties sought summary judgment following discovery. Avery Dennison asserted that the patent was ineligible for patent protection under 35 U.S.C. § 101, and ADASA argued that the asserted claims were not anticipated or obvious based on the book RFID for Dummies. The district court granted ADASA’s motion on validity and denied Avery Dennison’s motion for patent ineligibility. Prior to trial, ADASA moved in limine to exclude Avery Dennison’s damages expert’s testimony related to certain licenses, and the district court granted the motion.

At trial, ADASA entered licenses into evidence as part of its damages case and alleged that they reflected lump-sum agreements to practice the asserted patent. The district court declined to include a jury instruction on lump-sum damages and a lump-sum option on the verdict form, observing that Avery Dennison’s expert had not offered a lump-sum damages opinion and concluding that the licenses alone were insufficient for the jury to award lump-sum damages. The jury returned an infringement verdict and awarded ADASA a running royalty of $0.0045 per infringing RFID tag, which resulted in an award of $26.6 million.

In its post-trial motions, Avery Dennison moved for a new trial, arguing it was reversible error for the district court to exclude its damages expert’s testimony and to decline to provide a jury instruction for a lump-sum damages award. Before the district court ruled on its motion, Avery Dennison revealed to ADASA that it had discovered additional previously undisclosed RFID tags in its databases. A subsequent investigation determined that the number of undisclosed tags was more than two billion. Avery Dennison agreed to pay an additional $9.5 million in damages, which corresponded to the royalty rate determined by the jury. ADASA subsequently moved for sanctions. The district court award $20 million in sanctions after finding that Avery Dennison had engaged in protracted discovery failures and a continuous disregard for the seriousness of the litigation and its expected obligations. The sanctions award corresponded to a $0.0025 per-tag rate applied to both the adjudicated and late-disclosed tags. Avery Dennison appealed.

Avery Dennison challenged the district court’s summary judgment rulings, its denial of a new trial and its imposition of sanctions. The Federal Circuit affirmed the district court’s patent eligibility determination, finding that the patent “is directed to a specific, hardware-based RFID serial number data structure designed to enable technological improvements to the commissioning process,” which “is not a mere mental process,” and concluded that the claim was directed to patent-eligible subject matter.

[...]

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Seeing Eye to Eye: Preliminary Injunction Affirmed for Patent Filed After Accused Product Was Sold

by Katherine Pappas | Feb 17, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction, finding that the district court did not abuse its discretion, clearly err in its underlying factual findings or abuse its discretion in setting the scope of the preliminary injunction. BlephEx, LLC v. Myco Indus., Inc., Case Nos. 2021-1149; -1365 (Fed. Cir. Feb. 3, 2022) (Moore, Schall, O’Malley, JJ.)

Myco sells AB Max, a mechanical device with an attached swab used for treating an eye condition known as blepharitis. Myco began marketing AB Max at a trade show in February 2019. One month later, BlephEx filed an application that later issued as a patent. The patent is directed toward cleaning debris from an eye during treatment of ocular disorders, including blepharitis. According to the patent, prior art treatment for blepharitis included at-home treatment where the patient would use a cotton swab, fingertip or scrubbing pad to scrub the eyelid margin in order to remove debris. Patients would often fail to adequately cleanse the eyelid margin, however. The patent’s solution is an electromechanical device with an attached swab for use by an eyecare professional to clean the patient’s eyelid margins.

The day the patent issued, BlephEx sued Myco and its chairman, John R. Choate, alleging that Myco’s AB Max infringed BlephEx’s newly issued patent. BlephEx moved the district court for a preliminary injunction prohibiting Myco from selling, distributing or offering the AB Max for sale. Myco opposed, arguing that a prior art reference (Nichamin) raised a substantial question of invalidity. The district court disagreed with Myco and granted the injunction. The district court noted that to anticipate, a prior art reference must disclose all elements of a claim arranged as in the claim, and Nichamin did not disclose combining the electromechanical applicator device depicted in one embodiment with a swab disclosed in another. The district court also rejected Myco’s argument that the patent examiner failed to consider Nichamin because he did not substantively discuss it during prosecution. The district court further rejected Myco’s obviousness argument as unsupported by expert evidence, finding Myco failed to overcome “the safety concerns of attaching a swab that is soaked in an abrasive to the Nichamin hand-held device.”

After the district court granted the preliminary injunction, Myco moved for reconsideration and argued that the preliminary injunction was overbroad because the AB Max had noninfringing uses. The district court rejected Myco’s argument, finding it was untimely and presented hypothetical noninfringing uses that were “outweighed by evidence that the only actual use of the AB Max was to treat anterior blepharitis,” which would likely infringe the asserted patent. Myco appealed.

The Federal Circuit affirmed the preliminary injunction grant. With respect to Myco’s anticipation argument, the Court found “Myco offers nothing other than attorney argument as to what the highly skilled artisan would do,” and this was insufficient to raise a substantial question of validity. The Court also noted that Myco had “put all of its eggs in the anticipation basket” and fatally failed [...]

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IPR on Written Description? Claims Found Unpatentable Based on Lack of Entitlement to Priority Date

by Art Dykhuis | Dec 9, 2021 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) ruling, based on a written description analysis, that certain claims were invalid as anticipated by an earlier priority application from the same family. Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., Case Nos. 20-2073, -2142 (Fed. Cir. Nov. 24, 2021) (Lourie, J.) (Linn, J., concurring in part and dissenting in part).

Indivior’s patent, which issued from a fifth continuation application claiming priority back to 2009, claimed orally dissolvable films with therapeutic agents. Some of the claims recited numeric ranges, such as “about 40% wt to about 60% wt of a water-soluble polymeric matrix.” Instead of a range, one claim recited a specific amount of “about 48.2% wt” of the polymeric matrix. The patent’s specification did not expressly mention the claimed ranges or the specific 48.2% amount, but it did contain tables comprising quantities of polymer from which Indivior contended a person of ordinary skill in the art could calculate the percentage of polymer by weight.

Indivior argued that the polymer weight percentage limitations were supported by the priority application and, therefore, the patent was entitled to that priority date. Dr. Reddy’s contended that since the polymer weight percentage limitations were added later, an intervening patent publication (Myers) was prior art and anticipated the claims. Indivior did not contest that if Myers was prior art, it anticipated the claims. As a result, the Board’s decision on anticipation under 35 U.S.C. §102 turned on the priority analysis which, in turn, hinged on written description. The Board found that the tables disclosed formulations from which the “48.2% wt” could be calculated and, thus, claims reciting that limitation were not anticipated by Myers. However, the Board found that the claimed ranges (i.e., about 40% wt to about 60% wt) were not disclosed in the specification, and those claims were therefore anticipated by Meyers. Indivior appealed the Board’s anticipation finding, and Dr. Reddy’s appealed the no anticipation finding.

The Federal Circuit first analyzed the specification and concluded that there was no written description support for the broader range of “about 40% wt to about 60% wt.” The Court explained that the range was not disclosed in the specification, the specific values of 40% and 60% were not disclosed and there was another “inconsistent” teaching for weights of “at least 25%.” The Court noted that two specific tables in the specification “do not constitute ranges; they are only specific, particular examples. For written description support of a claimed range, more clarity is required.” The Court explained that “[h]ere, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the [] application to create an otherwise unstated range. That is not a written description of the claimed range.” The Court applied similar analysis in finding lack of written description for other claims reciting a slightly different range. Ultimately, the Court agreed that there was no written [...]

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Size Matters in Obviousness Analysis

by Paul Devinsky | Oct 29, 2020 | Patents

The US Court of Appeals for the Federal Circuit affirmed in part and reversed in part two Patent Trial and Appeal Board (Board) decisions, finding that the Board erred in its construction of certain claim terms relating to an artificial heart valve that does not require removal of the damaged native heart valve. St. Jude Medical, LLC v. Snyders Heart Valve LLC, Case Nos. 19-2108, -2109, -2140 (Fed. Cir. Oct. 15, 2020) (Taranto, J.).

St. Jude filed two petitions for inter partes review (IPR) of a patent for an artificial heart valve and a system for inserting the valve. Both petitions were instituted by the Board and resulted in final written decisions. In the first decision, the Board found that St. Jude failed to establish unpatentability of the challenged claims, rejecting St. Jude’s contention that all challenged claims were anticipated by and obvious over the Leonhardt prior art reference. In the second decision, the Board found that certain claims were anticipated by the Bessler prior art reference, but rejected St. Jude’s contentions as to all other claims. St. Jude appealed, arguing that the Board erred in the first decision by erroneously construing the term “band” and erred in the second decision by finding that St. Jude failed to prove that a skilled artisan would have made a particular combination of Bessler and the Johnson prior art. Snyders cross-appealed in the second decision as to the claims the Board found were anticipated by Bessler.

The Federal Circuit affirmed the Board’s conclusions in the first decision, finding that not only was the Board’s construction of the term “band” proper, but that it was actually broader than St. Jude’s proposed construction—and that St. Jude expressly accepted the Board’s construction. The Board construed the heart valve band to mean “a structure generally in the shape of a closed strip or ring” (replacing St. Jude’s “circular” with “closed”). In the prior art, Leonhardt discloses a graft material which extends the length of the entire structure. The Federal Circuit agreed with the Board’s finding that Leonhardt’s graft material was “like a sleeve” as opposed to “a closed strip or ring.” St. Jude argued that an ordinary skilled artisan’s understanding of the term “band” does not include a length restriction, that a Leonhardt’s material was just a long band, and that the Board effectively changed its construction of the term. The Federal Circuit, however, was not persuaded by St. Jude’s unlimited-length definition of “band,” instead turning to dictionary definitions that included terms like “thin” and “narrow,” and looking to the patent specification that did not explicitly disclaim any length restrictions. The Court ultimately rejected St. Jude’s arguments, finding that St. Jude should have proposed a claim construction that precluded any limitations on length if it wished to argue such. The Federal Circuit affirmed the Board’s findings as to first decision.

The Federal Circuit next addressed Snyder’s cross-appeal. Snyder disputed the board’s construction of the “size[] and shape[]” of a frame that the patent requires must be inserted [...]

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