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Medical Expertise – Latest Choices on the Federal Circuit and the Patent Trial and Attraction Board

Word: First printed by ALM / Legislation.com in The Mental Property Strategist


Latest developments on the Federal Circuit and the USPTO can inform evolving patent technique on medical expertise. In a single case, the Federal Circuit invalidated a patent referring to catheter insertion expertise. As well as, the Patent Trial and Attraction Board (“PTAB”) thought of material eligibility of medical expertise innovations in two selections issued lower than a 12 months aside. Within the first determination, the PTAB saved claims involving medical machine location. Within the second determination, the PTAB affirmed a last rejection of claims involving coronary heart failure stratification.


In a call that will have escaped due consideration, the Federal Circuit offered another excuse for medical expertise firms to not delay patent software filings. One foundation for early motion has been authorized penalties arising from preparations for advertising and marketing and sale of a medical machine invention, together with regulatory compliance. On this regard, medical expertise firms must be acquainted with patent validity points that may come up for a medical machine invention via, for instance, an early 510(ok) abstract or perhaps a referenced predicate machine. Lately, the Federal Circuit has offered a reminder that gross sales and advertising and marketing actions in different contexts can also bar patent rights on medical expertise.

In Junker v. Medical Elements, Inc., 2021-1649 (Fed. Cir. 2022), the Federal Circuit determined the difficulty of whether or not business actions referring to a medical machine previous to the essential date invoked the on sale bar of pre-AIA 35 U.S.C. § 102(b). The inventor created a brand new design for an peelable introducer sheath based mostly on his expertise with catheter insertion procedures. Particularly, the inventor centered on the design for the deal with of a peelable introducer sheath, which facilitated dealing with of the peelable introducer sheath throughout catheter-insertion procedures.

Previous to the essential date, a enterprise companion of the inventor conveyed a letter to a possible purchaser of the peelable introducer sheath. The letter offered a value chart for the peelable introducer sheath that specified numerous buy choices and related order portions. The letter characterised itself as a “citation.” The letter concluded with an invite to debate the potential purchaser’s particular necessities. As a result of the events within the litigation agreed that the patented design of the peelable introducer sheath was prepared for patenting on the time of the letter, the one remaining problem was whether or not the letter constituted a business provide on the market to set off the on sale bar. Though it acknowledged particular phrases offered within the letter, the district court docket discovered that use of the phrase “citation” indicated that the letter mirrored preliminary negotiations as a substitute of a particular provide.

The Federal Circuit reversed, making use of conventional contract legislation ideas and thus discovering that the letter was a business provide on the market. The Federal Circuit discovered that the letter was a response to a request for a citation and constituted a particular provide, not merely an invite to barter. Additional, the Federal Circuit discovered that the letter contained mandatory phrases which might be usually included in a business contract, comparable to cargo circumstances referring to the peelable introducer sheath. The Federal Circuit additionally famous the letter’s inclusion of various buy choices and specified quantity based mostly reductions. Primarily based partially on these issues, the Federal Circuit dominated that the necessities of an on sale bar had been glad, invalidating the patent on the peelable introducer sheath design.

Whereas Junker v. Medical Elements, Inc. is premised on pre-AIA part 102(b) in relation to a design patent, its rationale ought to apply equally to design patents and utility patents alike below AIA legislation. In view of this determination, medical expertise firms are reminded that business actions can erase patent rights. Industrial communications with particular phrases, even these which might be fastidiously crafted as invites to proceed discussions towards a doable transaction, can invoke the on sale bar. Thus, for innovations warranting patent safety, medical expertise firms ought to transfer swiftly to file patent functions, particularly if contemporaneous advertising and marketing or business actions are deliberate.


Sometimes, the PTAB will reverse an examiner’s last rejection. Rarer nonetheless is reversal of a last rejection based mostly on Alice Corp. v. CLS Financial institution Int’l, 573 U.S. 208, 216 (2014). In Ex parte Unfastened, Attraction 2022-001026 (PTAB June 6, 2022), the PTAB did each within the context of medical machine expertise. Nevertheless, lower than a 12 months later, the PTAB in Ex parte An, Attraction 2022-004092 (PTAB March 29, 2023) affirmed below Alice a last rejection of claims directed to coronary heart failure stratification. Ex parte Unfastened and Ex parte An are an informative distinction on disparate material eligibility outcomes.

A. Ex parte Unfastened

The invention in Ex parte Unfastened concerned project of a medical machine from a knowledge community to a bodily location. Declare 1 recited an intensive technique together with 9 steps that make the most of a medical machine, a knowledge community interface, a knowledge community machine, a knowledge community, and energetic community elements (e.g., routers). In declare 1, numerous messages (e.g., knowledge community messages, a gaggle message, request messages, an acknowledgement message) are exchanged among the many numerous community units and numerous knowledge units are offered. Declare 1 culminated in project of the medical machine to a affected person knowledge set that identifies a affected person. The recitations of declare 1 alone spanned greater than a web page.

Throughout prosecution, the examiner decided that the claims recited offering an project of a medical machine to a bodily location in an automatic method to switch and show knowledge related to a affected person. As such, the examiner rejected the claims below Alice as a psychological course of. The examiner additional decided each the absence of integration right into a sensible software and the absence of “considerably extra.”

The PTAB disagreed. First, the PTAB signaled its final determination by citing the prohibition set forth in Alice in opposition to characterization of patent claims at an unduly excessive stage and untethered from declare language. The PTAB then interpreted the declare as a “technique [that] includes offering a knowledge community machine, i.e., a {hardware} machine, that sends and receives knowledge community messages, e.g., knowledge packets, from a plurality of energetic community {hardware} elements, e.g., routers, and analyzes that info, along with saved knowledge, to assign a medical machine to a bodily location and, thereby, to a affected person knowledge set, which identifies a selected affected person.” With that interpretation, the PTAB discovered that the claims concerned steps, comparable to “polling {hardware} elements by sending and receiving knowledge community messages,” that as a sensible matter moderately couldn’t be carried out within the human thoughts.

The PTAB additionally rejected the place of the examiner that the claimed invention merely automated project of medical units to bodily places. The PTAB famous that standard strategies concerned direct handbook entry of location knowledge right into a medical machine itself. The PTAB contrasted these standard strategies from the claimed invention by underscoring that the traditional strategies didn’t depend on message change or community machine communications as did the actual course of recited within the claims. 

B. Ex parte An

Lower than a 12 months after, the PTAB in Ex parte An affirmed a last rejection of one other invention on medical associated expertise. In Ex parte An, the invention associated to quantification of a danger of worsening coronary heart failure (WHF) through the use of a physiological sensor circuit, comparable to a coronary heart sound sensor circuit and a respiration sensor circuit. Declare 1 recited as follows:

  • A system comprising:
    • a coronary heart sound sensor circuit configured to obtain a coronary heart sound sign of a topic;
    • a respiration sensor circuit configured to obtain a respiration sign of the topic;
    • a management circuit together with:
    • a sign processing circuit configured to:
    • produce a plurality of S3 coronary heart sound measurements utilizing the acquired coronary heart sound sign;
    • decide a day by day S3 coronary heart sound worth utilizing the plurality of S3 coronary heart sound measurements;
    • produce a plurality of respiration price measurements utilizing the acquired respiration sign; and
    • decide a consultant respiration price utilizing the plurality of respiration price measurements; and
    • a danger stratifier circuit configured to assign a danger class of worsening coronary heart failure (WHF) for the topic utilizing the consultant respiration price and the day by day S3 coronary heart sound worth; and
    • a show configured to current an alert of the chance class to a consumer.

Throughout prosecution, the examiner decided that the claims recite an summary concept by offering “steps for figuring out day by day, consultant, or central tendency measurements of varied parameters, and assigning a danger class of WHF for the topic utilizing the day by day, consultant or central tendency measurements.” In accordance with the examiner, the steps – aside from generically recited laptop elements and mathematical ideas – could possibly be carried out within the human thoughts. The examiner additional decided that the extra components within the claims had been inadequate to represent integration of the summary concept right into a sensible software.

The PTAB affirmed. As to Prong One, the applicant inexplicably didn’t contest the examiner’s discovering of an summary concept. Because of this, the PTAB discovered no error there. As to Prong Two, the PTAB indicated that the extra components past the judicial exception included circuits configured to implement steps of the summary concept and a show to current an alert. The PTAB characterised the circuits and show as “merely” generically recited laptop elements that

typically hyperlink use of a judicial exception to a sure technological setting or area of use. In explaining its determination, the PTAB said that the specification of the appliance at problem described solely generic laptop elements. For instance, the PTAB pointed to a pertinent determine of the appliance that included a sensor circuit consultant of a coronary heart sound sensor circuit and a respiration sensor circuit that was depicted as a black field. In concluding its evaluation of Prong Two, the PTAB rejected the applicant’s competition that the mixture of day by day S3 coronary heart sound and respiration price offered an enchancment to the related expertise or technical area of machine based mostly affected person monitoring and WHF danger stratification. Along with the PTAB’s place that the claimed circuits and show had been generic laptop elements performing generic laptop capabilities, the PTAB rejected the applicant’s competition as a result of the mixture of day by day S3 coronary heart sound and respiration price had been lined by the summary concept, not the extra components that must be the main target of the Prong Two inquiry.

After concluding that the claims had been directed to an summary concept, the PTAB subsequent thought of below Step 2B whether or not the extra components of the claims amounted to an ingenious idea. For this inquiry, the PTAB as soon as once more emphasised that the generically recited circuits and show carried out fundamental laptop capabilities that could possibly be carried out by a generic laptop. Because of this, the PTAB didn’t discover something that was “considerably extra” than an instruction to use the summary concept to a generic laptop.

C. Classes

The examiner in Ex parte Unfastened embraced a broadest cheap interpretation that characterised claimed performance that was quintessentially non-human as one way or the other performable by the human thoughts. In response, the PTAB offered a useful, albeit uncommon, test on that exuberance by recognizing important technical element recited within the claims. By comparability, Ex parte An concerned functionally recited claims with little, if any, implementation element. Nor may the specification assist extra element, given its disclosure of a generic laptop. Because of this, the absence of technical specificity doomed the claims to material ineligibility. 

These selections counsel that, if Alice points probably come up, draft and amend claims with a sure stage of technical specificity, a regular that’s usually achievable with medical expertise. For instance, the mechanisms that obtain, analyze, manipulate, convey, and rework alerts, biomarkers, or different sorts of medical or physiological expression, and their technical operate, could be specified within the claims to keep away from Alice. As one other instance, if there’s an precise circuit or a {hardware} configuration to probably declare, ask your inventors to proceed past a black field description. As soon as a sure stage of element is recited that moderately excludes human efficiency, your claims will likely be extra clearly eligible. On the identical time, the rationale of Ex parte Unfastened could be leveraged to remind your examiner that the attain of Alice has acknowledged limits.


These Federal Circuit and PTAB selections inform pre-filing and post-filing patent methods for medical expertise firms. Junker v. Medical Elements, Inc. warrants warning in early advertising and marketing and gross sales actions. On this regard, pre-filing communications referring to an invention, probably even these crafted to protect patent rights, can implicate the on sale bar. Ex parte Unfastened and Ex parte An illustrate disparate outcomes below Alice based mostly on declare scope. Your skill to resort to narrower claims to keep away from Alice throughout prosecution might effectively depend upon efficient planning on the drafting stage.

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