A method for monitoring of cardiac conditions incorporating an implantable medical device in a subject, the method comprising the steps of:
collecting [step 1] physiological data associated with the subject from the implantable device at preset time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data;
comparing [step 2] the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event;
triggering [step 3a] an alarm state if the electro cardiac signal data is not within the threshold electrocardiac criteria;
determining [step 3b] the current activity level of the subject from the activity level data if the electrocardiac signal data is within the threshold electrocardiac criteria;
determining [step 4] whether the current activity level is below a threshold activity level;
comparing the tissue perfusion data with a threshold tissue perfusion criteria for indicating a strong likelihood of a cardiac event if the current activity level is determined to be below a threshold activity level; (後略)
在許多方法、流程、步驟的技術概念中，if, then, else是非常普遍的處理邏輯，但透過這個案例可以得知，以這樣conditional limitation的方式來撰寫方法項，將導致申請人面對USPTO時處於非常不利的地位。首先，根據MPEP的記載，若在單線、不分岔的流程中，if所引導的條件未必會發生，則對該方法項之審查很可能得以正當地忽略自if所在的步驟，及其之後的步驟；其次，以Ex parte Schulhauser為例，若在分岔的流程中，if所引導的各個條件將涵蓋事件的100%可能性[2]，則對該方法項之審查很可能會針對步驟最少即可實施完成該方法的「走法」，亦即該方法項的最廣範圍。
日前聽聞網路論壇上的一些外國同行在討論，不使用if，而改用when，甚至更複雜的文字，例如某步驟based upon某條件，來規避方法項的BRI原則。但筆者參照MPEP及Ex parte Schulhauser細部內容後，並不認為上述方式將有所助益[3]，審查員理所當然的會拆解、分析繫屬的方法項，寄望審查員一時閃神而沒發現conditional limitation，這種想法未免過於天真。
回說Ex parte Schulhauser，如下圖，申請人先是把triggering an alarm state if the… (step 3a) 此步驟給刪除了，讓該方法項轉變為單線、不分岔的流程，更重要的是加上了正面肯定的句式：determining the electrocardiac signal data is within the threshold electrocardiac criteria，這樣的修正導致該方法項直接針對條件符合的狀況來展開後續步驟，免去了conditional limitation，最終該方法項以此型態通過了審查。
