First revealed by ALM / Legislation.com in The Mental Property Strategist.
I. INTRODUCTION
This text briefly analyzes latest Patent Trial and Enchantment Board (“PTAB”) choices on medical know-how incorporating synthetic intelligence (AI). Every resolution entails reversal of a previous artwork rejection and contrasts with the opposite choices on subject material eligibility. The improvements at concern relate to a variety of medical applied sciences regarding anatomical location-based machine studying fashions to foretell pathological abnormalities, operation of a robotic surgical machine prompted by an intra-operative surgical advice, and polygenic fashions to foretell traits of people based mostly on genetic variants. The choices reveal completely different PTAB approaches and outcomes that may inform prosecution and enchantment methods.
II. PTAB DECISIONS
A. Reversal of Prior Artwork Rejection, No Alice Concern
In Ex Parte Lyman, Enchantment No. 2022-002753 (PTAB Sept. 25, 2023), an enchantment to the PTAB concerned know-how regarding AI-based evaluation of medical scans generated by medical imaging units. The know-how makes use of picture knowledge 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 lessons, similar 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 knowledge and coaching a plurality of anatomical location-based machine studying fashions by efficiency of a fantastic tuning step on the generic machine studying mannequin. Within the claims, mutually unique subsets of the medical scan knowledge are generated based mostly on completely different anatomical places. The claims additional recited that, with respect to fantastic tuning, a subset of the medical scan knowledge regarding an anatomical location is utilized to coach a corresponding machine studying mannequin related to the anatomical location.
The only real concern 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 completely different fashions, every mannequin skilled utilizing a corresponding subset of knowledge. Nevertheless, 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. Consequently, the PTAB reversed the prior artwork rejection of the claims.
On this case, no Alice points had 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 fantastic 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 know-how of medical imaging. Unpersuaded by these arguments, the examiner famous that, underneath a broadest cheap 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, Sudden Alice Concern
Ex parte Couture, Enchantment No. 2023-002437 (PTAB Sept. 28, 2023) was an enchantment involving a machine studying mannequin skilled to supply an intra-operative surgical advice to a surgeon working a robotic surgical machine. The robotic surgical machine 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 machine and a machine studying engine able to producing a machine studying mannequin skilled based mostly on coaching knowledge. The coaching knowledge as claimed features a set of robotic surgical process weights based mostly on robotic surgical treatment knowledge related to a optimistic surgical process end result. Within the claims, the robotic surgical process weights are related to surgical end result metrics. The applicant appealed closing rejection of the claims underneath part 103, the one excellent rejection.
Your entire PTAB panel discovered that the recitation of coaching knowledge distinguished the claims over the prior artwork references. A key prior artwork reference disclosed a machine studying system and process end result knowledge related to a consequence from a surgical process, together with whether or not the consequence was optimistic or damaging. Nevertheless, the panel discovered no disclosure within the reference that the process end result knowledge 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 machine and a skilled machine studying mannequin to find out a surgical prediction and, in line with 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 machine parts had been generically claimed, together with a generically claimed machine studying engine. Regardless of the recited element relating to the machine studying mannequin skilled on particular coaching knowledge together with robotic surgical process weights based mostly on robotic surgical treatment knowledge, the APJ characterised the claims as masking using any kind 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 methods similar 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 relating to the machine studying mannequin skilled on particular coaching knowledge and related era of a robotic surgical process prediction, the APJ contended that use of a nondescript machine studying engine with a robotic machine was related to the summary concept itself, not a technological enchancment. The APJ didn’t talk about whether or not extra categorical recital of coaching and use of a selected machine studying mannequin skilled with the claimed coaching knowledge 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 era 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, Enchantment No. 2022-001298 (PTAB Might 11, 2023) concerned know-how regarding polygenic fashions that predict traits of people based mostly on genetic variants of the people. Traits can embody, for instance, phenotypes and behaviors of people. The claims recited dedication 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 laptop. As to the second prong, the PTAB thought-about the remaining further 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 acknowledged that the working step merely carried out 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 traditional. 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 technique to probably bolster subject material eligibility. In a single a part of its resolution, the PTAB noticed that the claims didn’t recite growing laptop fashions able to predicting traits by making use of particular machine studying strategies to particular datasets. Moderately, in line with the PTAB, the claims merely required storing preexisting machine studying fashions which have already been skilled.
III. CONCLUSION
These choices recommend that PTAB appeals on medical know-how 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 received — 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 fantastic 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 increase a brand new query. Moderately, and maybe to the applicant’s shock, the APJ went as far as to supply a prolonged rationalization as to why the pretty detailed claims on a robotic surgical machine and a machine studying engine had been purportedly ineligible. Even in a case the place two APJs and an examiner agree, one continues to be left to surprise concerning the worth of a patent issued with invalidity arguments of an APJ prominently set forth within the file historical past and, extra essentially, the suitable circumstances for an enchantment that justify such danger.
In fact getting the enchantment you need is completely 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 an entire 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 route.
