案例資訊：
專利權人/原告：CONTOURMED INC.
侵權被告：AMERICAN BREAST CARE L.P.
系爭專利：US 7,058,439
背景：
專利權人ContourMed Inc.算是一間醫療用品公司，提供乳癌患者更換義乳的服務，擁有的系爭專利關於形成義肢/義乳的方法，實際上是對乳房切除者訂製義乳的方法。被告American Breast Care L.P. (“ABC”)也是提供義乳的公司。ContourMed Inc.於2015年對ABC提告，提出惡意侵權與損害賠償的主張。
被告ABC則是提出專利無效之訴，認為系爭專利技術僅是以一般目的電腦處理一般掃描機產出數據的技術（沒有significantly more的技術貢獻），為抽象概念，不符專利法第101條規定。專利權人回應為，其中掃描系統並非一般目的電腦，可以將相關抽象技術轉換為可專利標的。
系爭專利所稱方法包括掃描病患身體取得影像，其中討論到影像校準的技術，根據病患胸部形狀建立數據資料，判斷出電腦模型，使用校準的資訊以第一電腦模型轉換為第二電腦模型，再掃描取得切除乳房的數據，之後根據以上數據形成義乳模型。
US 7,058,439：
系爭專利關於一種形成假體（義肢、義乳）的方法，就方法專利而言，就是一系列步驟的組合：
1. A method of forming a model of a breast prosthesis for a patient who has had one breast at least partially removed, comprising:
providing a scanning system comprising one or more imaging devices and one or more alignment markers, wherein at least one of the alignment markers comprises a tangible object, wherein the tangible object is noticeable in a scanned image and may be used to manipulate a scanned image as a reference point;
arranging at least one of the alignment markers in the middle of the body of the patient and within the field of view of at least one of the imaging devices;
determining a first set of data elements using the scanning system is based on a shape of the patient's intact breast;
determining a first computer model of the intact breast based on the first set of data elements;
using at least one of the alignment markers in the middle of the body of the patient as a fixed reference point relative to the patient to determine alignment of the first computer model of the intact breast;
applying a reflection transformation to the first computer model of the intact breast to form a second computer model, the second computer model comprising a second set of data points that represents a mirror image of the first computer model;
determining a third set of data elements using the scanning system based on a surgical site at which the breast was at least partially removed;
determining a third computer model based on the third set of data elements; and combining the third computer model and the second computer model to form a breast prosthesis model, wherein the second computer model defines an anterior portion of the breast prosthesis model that mirrors the intact breast and the third computer model defines a posterior portion of the breast prosthesis model that is custom fit to the surgical site.
關於35 U.S.C. 101議題，顯然就會碰觸Alice Corp. v. CLS Bank International最高法院意見，以及USPTO所規範的兩階段測試（two-part test），據此判斷系爭專利發明是否為可專利標的：法院應判斷是否系爭專利範圍涉及「不可專利的抽象概念」，若系爭專利範圍屬於不可專利的抽象概念，而應考量專利範圍的技術元件的個別或組合是否「可轉換請求項範圍為可專利的應用」？或說："是否專利請求項引述了實質超越（significantly more）不可專利（自然律、自然現象、抽象概念）的其他元件？""First, the court must determine “whether the claims at issue are directed to one of those patent-ineligible concepts.” Id. Second, if the patent is directed to a patent-ineligible concept, the court then “consider[s] the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.”"
專利權人ContourMed主張系爭專利範圍中的「scanning system」具有攝像裝置以及所需的校準標記，用以建立3D模型；反之，被告ABC則認為系爭專利發明僅是使用一般掃描系統的一般目的電腦（這也就是說，如果系爭專利僅是利用一般掃描機的數據，而沒有實質超越（significantly more），系爭專利可能不符可專利標的的規定）。
從法院意見可以得到一般判斷原則，不會是一般單方面的主觀判斷而已。其中，先定義「抽象概念」比如利用數學方法的技術，或是商業模式，但仍需要看實質技術為何而定，如Bilski就僅是解決財務交易（financial transaction）風險的數學方法，Alice案為利用第三方角色降低清算（settlement）風險的金融方法。
地院結論：
不同於以上判例的金融交易技術，本案系爭專利發明並非僅應用掃描機數據的技術，而是以軟體方法執行3D建模的技術。不過，對此判斷，法院仍提醒，判斷發明是否為抽象概念，不能僅看發明結果，而是應著重在發明技術本身。
"While the process claimed in the ‘439 Patent does employ software to process images and perform 3D modeling, the underlying concept involves substantial tangible components."
最後，即便提醒發明是否具有可專利性不能僅看輸出結果（如3D模型）而是應看發明本身，仍認定系爭專利發明具有「實質超越一般數據處理與儲存」的技術元件，為可專利的標的。否決被告ABC的訴求。
"Even taking this cautionary note into consideration, the ‘439 Patent still falls outside of the abstract ideas in the precedent because the concept of the invention involves substantially more than mere data collection and storage and does not threaten to preempt the use of scanners and computer modeling in other fields."
my two cents:
其實本案就技術本身而言，（希望不是我的後見之明），明確為利用具體掃描裝置（particular machine）執行的技術，並非一般目的電腦處理一堆數據的技術，應具有可專利性。且系爭專利範圍中並非一些數據處裡的步驟而已，而是處處連結特定硬體，有掃描系統、校準標記，且超越一般電腦系統的工作，且達成具體有意義的目的，其產出也為具體物件 - 義肢（義乳為主要標的），而不是一般資料輸出而已。
案例參考：
軟體專利（CAFC判決：CLS Bank v. Alice Corp.）（http://enpan.blogspot.tw/2013/05/cafccls-bank-v-alice-corp.html）
USPTO可專利性教戰守則 - TWO-STEP TEST（http://enpan.blogspot.tw/2014/12/uspto-two-step-test.html）
資料來源：
http://www.allthingspros.com/2016/03/101-alice-mayo-modeling-data-abstract_23.html
判決備份：https://app.box.com/s/jlfdan2w1lvuvbtrulblznzxgxecujyy
Ron
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