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

I. INTRODUCTION

Current developments on the Federal Circuit and the USPTO can inform evolving patent technique on medical know-how. In a single case, the Federal Circuit invalidated a patent regarding catheter insertion know-how. As well as, the Patent Trial and Enchantment Board (“PTAB”) thought of material eligibility of medical know-how 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 closing rejection of claims involving coronary heart failure stratification.

II. ON SALE BAR AND THE FEDERAL CIRCUIT

In a choice that will have escaped due consideration, the Federal Circuit supplied another excuse for medical know-how firms to not delay patent utility 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 know-how firms ought to be conversant in 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. Not too long ago, the Federal Circuit has supplied a reminder that gross sales and advertising and marketing actions in different contexts can also bar patent rights on medical know-how.

In Junker v. Medical Parts, Inc., 2021-1649 (Fed. Cir. 2022), the Federal Circuit determined the problem of whether or not industrial actions regarding a medical machine previous to the crucial 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 primarily based on his expertise with catheter insertion procedures. Particularly, the inventor targeted 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 crucial date, a enterprise associate of the inventor conveyed a letter to a possible purchaser of the peelable introducer sheath. The letter supplied a value chart for the peelable introducer sheath that specified varied 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 subject was whether or not the letter constituted a industrial supply on the market to set off the on sale bar. Though it acknowledged particular phrases supplied within the letter, the district courtroom discovered that use of the phrase “citation” indicated that the letter mirrored preliminary negotiations as a substitute of a particular supply.

The Federal Circuit reversed, making use of conventional contract regulation rules and thus discovering that the letter was a industrial supply on the market. The Federal Circuit discovered that the letter was a response to a request for a citation and constituted a particular supply, not merely an invite to barter. Additional, the Federal Circuit discovered that the letter contained vital phrases which are sometimes included in a industrial contract, comparable to cargo circumstances regarding the peelable introducer sheath. The Federal Circuit additionally famous the letter’s inclusion of various buy choices and specified quantity primarily based reductions. Primarily based partially on these concerns, the Federal Circuit dominated that the necessities of an on sale bar have been glad, invalidating the patent on the peelable introducer sheath design.

Whereas Junker v. Medical Parts, 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 underneath AIA regulation. In view of this determination, medical know-how firms are reminded that industrial actions can erase patent rights. Business communications with particular phrases, even these which are rigorously crafted as invites to proceed discussions towards a potential transaction, can invoke the on sale bar. Thus, for innovations warranting patent safety, medical know-how firms ought to transfer swiftly to file patent functions, particularly if contemporaneous advertising and marketing or industrial actions are deliberate.

III. SUBJECT MATTER ELIGIBILITY AT THE BOARD

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

A. Ex parte Free

The invention in Ex parte Free concerned task of a medical machine from a knowledge community to a bodily location. Declare 1 recited an in depth methodology 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 parts (e.g., routers). In declare 1, varied messages (e.g., information community messages, a bunch message, request messages, an acknowledgement message) are exchanged among the many varied community units and varied information units are supplied. Declare 1 culminated in task of the medical machine to a affected person information 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 task of a medical machine to a bodily location in an automatic method to switch and show information related to a affected person. As such, the examiner rejected the claims underneath Alice as a psychological course of. The examiner additional decided each the absence of integration right into a sensible utility and the absence of “considerably extra.”

The PTAB disagreed. First, the PTAB signaled its final determination by citing the prohibition set forth in Alice towards characterization of patent claims at an unduly excessive stage and untethered from declare language. The PTAB then interpreted the declare as a “methodology [that] contains offering a knowledge community machine, i.e., a {hardware} machine, that sends and receives information community messages, e.g., information packets, from a plurality of energetic community {hardware} parts, e.g., routers, and analyzes that info, together with saved information, to assign a medical machine to a bodily location and, thereby, to a affected person information set, which identifies a specific affected person.” With that interpretation, the PTAB discovered that the claims concerned steps, comparable to “polling {hardware} parts by sending and receiving information 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 task of medical units to bodily places. The PTAB famous that typical methods concerned direct handbook entry of location information right into a medical machine itself. The PTAB contrasted these typical methods from the claimed invention by underscoring that the traditional methods didn’t depend on message alternate 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 closing rejection of one other invention on medical associated know-how. In Ex parte An, the invention associated to quantification of a threat 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 threat stratifier circuit configured to assign a threat 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 danger class to a consumer.

Throughout prosecution, the examiner decided that the claims recite an summary thought by offering “steps for figuring out day by day, consultant, or central tendency measurements of assorted parameters, and assigning a threat class of WHF for the topic utilizing the day by day, consultant or central tendency measurements.” In keeping with the examiner, the steps – other than generically recited pc parts and mathematical ideas – might be carried out within the human thoughts. The examiner additional decided that the extra parts within the claims have been inadequate to represent integration of the summary thought right into a sensible utility.

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

typically hyperlink use of a judicial exception to a sure technological surroundings or area of use. In explaining its determination, the PTAB acknowledged that the specification of the appliance at subject described solely generic pc parts. 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 mix of day by day S3 coronary heart sound and respiration price supplied an enchancment to the related know-how or technical area of machine primarily based affected person monitoring and WHF threat stratification. Along with the PTAB’s place that the claimed circuits and show have been generic pc parts performing generic pc capabilities, the PTAB rejected the applicant’s competition as a result of the mix of day by day S3 coronary heart sound and respiration price have been lined by the summary thought, not the extra parts that ought to be the main target of the Prong Two inquiry.

After concluding that the claims have been directed to an summary thought, the PTAB subsequent thought of underneath Step 2B whether or not the extra parts of the claims amounted to an creative idea. For this inquiry, the PTAB as soon as once more emphasised that the generically recited circuits and show carried out primary pc capabilities that might be carried out by a generic pc. Consequently, the PTAB didn’t discover something that was “considerably extra” than an instruction to use the summary thought to a generic pc.

C. Classes

The examiner in Ex parte Free embraced a broadest cheap interpretation that characterised claimed performance that was quintessentially non-human as by some means performable by the human thoughts. In response, the PTAB supplied a useful, albeit uncommon, examine on that exuberance by recognizing vital technical element recited within the claims. By comparability, Ex parte An concerned functionally recited claims with little, if any, implementation element. Nor might the specification help extra element, given its disclosure of a generic pc. Consequently, the absence of technical specificity doomed the claims to material ineligibility. 

These selections recommend that, if Alice points doubtlessly come up, draft and amend claims with a sure stage of technical specificity, a regular that’s usually achievable with medical know-how. For instance, the mechanisms that obtain, analyze, manipulate, convey, and remodel indicators, biomarkers, or different forms of medical or physiological expression, and their technical operate, will 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 doubtlessly 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 shall be extra clearly eligible. On the identical time, the rationale of Ex parte Free will be leveraged to remind your examiner that the attain of Alice has acknowledged limits.

IV. CONCLUSION

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