First revealed by ALM / Legislation.com in The Mental Property Strategist.
This text briefly analyzes current Patent Trial and Attraction Board (“PTAB”) choices on medical expertise incorporating synthetic intelligence (AI). Every resolution includes reversal of a previous artwork rejection and contrasts with the opposite choices on material eligibility. The improvements at challenge relate to a spread of medical applied sciences regarding anatomical location-based machine studying fashions to foretell pathological abnormalities, operation of a robotic surgical gadget prompted by an intra-operative surgical suggestion, and polygenic fashions to foretell traits of people based mostly on genetic variants. The selections reveal totally different PTAB approaches and outcomes that may inform prosecution and enchantment methods.
II. PTAB DECISIONS
A. Reversal of Prior Artwork Rejection, No Alice Challenge
In Ex Parte Lyman, Attraction No. 2022-002753 (PTAB Sept. 25, 2023), an enchantment to the PTAB concerned expertise referring to AI-based evaluation of medical scans generated by medical imaging gadgets. The expertise makes use of picture information from a medical scan to coach machine studying fashions based mostly on datasets of medical scans and related labels. The labels relate to pathological abnormality courses, akin to atelectasis, effusion, mass, pneumonia, consolidation, emphysema, pleural thickening, cardiomegaly, infiltration, nodule, pneumothorax, edema, fibrosis, and hernia. In related half, the claims recited coaching a generical machine studying mannequin based mostly on a set of medical scan information and coaching a plurality of anatomical location-based machine studying fashions by efficiency of a wonderful tuning step on the generic machine studying mannequin. Within the claims, mutually unique subsets of the medical scan information are generated based mostly on totally different anatomical areas. The claims additional recited that, with respect to wonderful tuning, a subset of the medical scan information referring to an anatomical location is utilized to coach a corresponding machine studying mannequin related to the anatomical location.
The only real challenge on enchantment was the correctness of the rejection of the claims underneath part 103. Specifically, a previous artwork reference relied upon by the examiner disclosed a single course of to coach three totally different fashions, every mannequin skilled utilizing a corresponding subset of information. Nonetheless, the PTAB famous that the prior artwork reference failed to show coaching of the claimed generic machine studying mannequin and coaching of location-based fashions utilizing distinct subsets of the information used to coach the generic machine studying mannequin. Because of this, the PTAB reversed the prior artwork rejection of the claims.
On this case, no Alice points have been delivered to or raised by the PTAB. Notably, an early model of the claims recited, inter alia, producing a generic mannequin by efficiency of a coaching step and producing a plurality of location-based fashions by efficiency of a wonderful tuning step. Throughout prosecution, the examiner rejected this model of the claims, discovering that the claims coated a way of organizing human exercise. In response, the applicant argued that the claims didn’t contain folks in any respect, a lot much less managing private habits or relationships between folks, and that the claims recited a sensible utility within the type of an enchancment to the expertise of medical imaging. Unpersuaded by these arguments, the examiner famous that, underneath a broadest affordable interpretation, the claims didn’t recite use of a machine studying mannequin and accordingly urged declare amendments to recite “coaching and use” of a machine studying mannequin. After a declare modification heeding that recommendation, the Alice rejection was withdrawn earlier than the enchantment.
B. Reversal of Prior Artwork Rejection, Surprising Alice Challenge
Ex parte Couture, Attraction No. 2023-002437 (PTAB Sept. 28, 2023) was an enchantment involving a machine studying mannequin skilled to offer an intra-operative surgical suggestion to a surgeon working a robotic surgical gadget. The robotic surgical gadget can be utilized to carry out, for instance, a knee arthroplasty, a hip arthroplasty, or a shoulder arthroplasty. The claims recited a system together with a robotic surgical gadget and a machine studying engine able to producing a machine studying mannequin skilled based mostly on coaching information. The coaching information as claimed features a set of robotic surgical process weights based mostly on robotic surgery information related to a constructive surgical process final result. Within the claims, the robotic surgical process weights are related to surgical final result metrics. The applicant appealed remaining rejection of the claims underneath part 103, the one excellent rejection.
Your entire PTAB panel discovered that the recitation of coaching information distinguished the claims over the prior artwork references. A key prior artwork reference disclosed a machine studying system and process final result information related to a consequence from a surgical process, together with whether or not the consequence was constructive or unfavorable. Nonetheless, the panel discovered no disclosure within the reference that the process final result information was based mostly on the claimed robotic surgical process weights. The panel thus concluded that the examiner erred and reversed the rejection of the claims.
One administrative patent choose concurred within the resolution, sua sponte asserting that declare 1 failed the Alice check. The APJ acknowledged however faulted the examiner’s withdrawal of part 101 rejections in prosecution based mostly on sure declare amendments. The declare amendments recited a surgical gadget and a skilled machine studying mannequin to find out a surgical prediction and, in response to the examiner, constituted integration of an summary concept right into a sensible utility. As to step 1 of the Alice check, the APJ asserted that every one gadget parts have been generically claimed, together with a generically claimed machine studying engine. Regardless of the recited element concerning the machine studying mannequin skilled on particular coaching information together with robotic surgical process weights based mostly on robotic surgery information, the APJ characterised the claims as masking the usage of any sort of machine studying and never reciting technological implementation particulars. As to step 2, the APJ argued that the applicant couldn’t contend that it invented a machine studying engine, citing point out within the specification to strategies akin to synthetic neural networks, Bayesian networks, instance-based studying, assist vector machines, and resolution bushes. Once more, with out addressing the detailed recitation within the claims concerning the machine studying mannequin skilled on particular coaching information and related technology of a robotic surgical process prediction, the APJ contended that use of a nondescript machine studying engine with a robotic gadget was related to the summary concept itself, not a technological enchancment. The APJ didn’t focus on whether or not extra categorical recital of coaching and use of a particular machine studying mannequin skilled with the claimed coaching information together with the robotic surgical process weights would represent an enchancment or ingenious idea to fulfill the second prong of step 2A or step 2B. On this regard, it was the technology of a process prediction output based mostly on the claimed robotic surgical process weights in reference to a machine studying mannequin that supported reversal of the part 103 rejection.
C. Reversal of Prior Artwork Rejection, Affirmance of Alice Rejection
Ex parte Trunck, Attraction No. 2022-001298 (PTAB Could 11, 2023) concerned expertise referring to polygenic fashions that predict traits of people based mostly on genetic variants of the people. Traits can embrace, for instance, phenotypes and behaviors of people. The claims recited willpower of a demographic to which a person belongs based mostly on genetic variants of the person. Within the claims, a polygenic mannequin from a set of polygenic fashions within the type of skilled machine studying fashions is chosen to make a prediction of a attribute of the person. The chosen polygenic mannequin, as claimed, has been skilled utilizing recognized genotypes and traits for members of the demographic. The claims additional recited operation of the chosen polygenic mannequin to make the prediction. The applicant appealed rejection of the claims based mostly on sections 101 and 103.
As to the primary prong of step 2A, the PTAB discovered that sure claimed steps might be carried out within the human thoughts or with pen and paper and that the claimed polygenic prediction server was merely a generic pc. As to the second prong, the PTAB thought-about the remaining extra parts that recited storing the polygenic fashions at a polygenic prediction server and working the chosen polygenic mannequin to make the prediction of the attribute. The PTAB said that the working step merely applied the summary concept on a pc and concluded that the extra parts didn’t combine the summary concept right into a sensible utility. As to step 2B, the PTAB relied on prior artwork references cited by the examiner for part 103 rejections to say that skilled machine studying fashions that predict a attribute of a person based mostly on genetic variants of the person are well-understood, routine, and standard. The PTAB affirmed the rejection underneath part 101 however on procedural concerns reversed the rejection underneath part 103 as a result of the examiner didn’t cite particular parts of the prior artwork references.
Regardless of its final ruling, the PTAB hinted at a approach to probably bolster material eligibility. In a single a part of its resolution, the PTAB noticed that the claims didn’t recite growing pc fashions able to predicting traits by making use of particular machine studying strategies to particular datasets. Moderately, in response to the PTAB, the claims merely required storing preexisting machine studying fashions which have already been skilled.
These choices recommend that PTAB appeals on medical expertise incorporating AI are probably winnable however nonetheless unpredictable. In some instances, the scope of points taken to the PTAB is similar scope thought-about by it. For instance, in Ex parte Lyman, the enchantment the applicant needed on part 103 alone is the enchantment the applicant acquired — and gained. Right here, and within the different two choices, the applicant prevailed on its prior artwork place, maybe contrasting AI associated medical applied sciences from different crowded fields the place reversals could also be much less widespread. After the applicant and the examiner reached settlement on Alice, the PTAB didn’t proactively rethink the sufficiency of an categorical recital of coaching and use of an anatomical location-based machine studying mannequin based mostly on a wonderful tuning step.
However coming to settlement with an examiner on part 101 points won’t essentially immunize an enchantment from Alice. The APJ in Ex parte Couture didn’t merely sua sponte elevate a brand new query. Moderately, and maybe to the applicant’s shock, the APJ went as far as to offer a prolonged rationalization as to why the pretty detailed claims on a robotic surgical gadget and a machine studying engine have been purportedly ineligible. Even in a case the place two APJs and an examiner agree, one continues to be left to surprise in regards to the worth of a patent issued with invalidity arguments of an APJ prominently set forth within the file historical past and, extra essentially, the proper circumstances for an enchantment that justify such danger.
After all getting the enchantment you need is totally different from getting the consequence you need. Based mostly on revealed statistics, PTAB settlement with the examiner, just like the end in Ex parte Trunck, shouldn’t be a whole shock. Given discretion laden realities in utility of amorphous Alice ideas, the candy spot with some luck typically lies inside attain. Though the enchantment was misplaced, the applicant in Ex parte Trunck was lucky to obtain an obvious nudge by the PTAB in a promising course.