美國
修改專利適格性審查基準，自2019年1月7日起生效

【資料來源：Federal Register】

USPTO在短期間內已完成修訂《專利適格性審查基準》（2019 Revised Patent Subject Matter Eligibility Guidance），並自2019年1月7日起生效。這次修改整理了近年來美國聯邦最高法院與巡迴上訴法院的見解，修改了原本USPTO MPEP 2106中關於適格性判斷的流程，對美國專利申請非常重要。

1. 抽象概念的「群組（Groupings）」

USPTO根據近幾年的法院判決，整理出所謂「抽象概念」的三個「群組」：數學概念（mathematical concepts）、整理人類活動的方法（certain methods of organizing human activity）、以及心智活動（mental processes）。如果cliams落入這三個群組，將有很高的機率被認為是抽象概念，如果沒有落入，則被認為是抽象概念的機率相對很低：

(a) Mathematical concepts—mathematical relationships, mathematical formulas or equations, mathematical calculations; 

(b) Certain methods of organizing human activity—fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and

(c) Mental processes—concepts performed in the human mind  (including an observation, evaluation, judgment, opinion).

最大的問題是：如果審查委員認為claim雖然沒有落入這三個群組本身，卻仍然是抽象概念，那麼後續恐怕很麻煩。這個抽象概念的claim會被列為「暫時的抽象概念 （tentative abstract idea）」，依照整個流程進行後，這個包括了暫時的抽象概念的claim如果還是被認為不適格，這個案子依Section III.C，就必須交技術中心主管（Technical Center Director）批准。批准的過程會列入申請歷史檔案。

2. 澄清何謂「指向（direct to）｣抽象概念

Alice兩部測試法的第一步（也就是USPTO原本適格性判斷流程圖的2A）的重點之一，在於判斷claim是否「指向」一種司法例外（judicial exception），即抽象概念、自然現象或自然法則。然而，多年以來到底甚麼叫做「指向」司法例外，一直沒有一個很清楚的判斷的標準。

依據USPTO新的2019年版審查基準，往後如果審查委員判斷claim提到一個司法例外，必須判斷這個司法例外是否整合進入一個該司法例外的實際應用。如果claim從整體觀之，所提到的司法例外被整合到了一個實際應用，則表示該請求項並未「指向（direct to）｣該司法例外。

[原文] In accordance with judicial precedent, and to increase consistency in examination practice, the 2019 Revised Patent Subject Matter Eligibility Guidance sets forth a procedure to determine whether a claim is “directed to” a judicial exception under USPTO Step 2A. Under the procedure, if a claim recites a judicial exception (a law of nature, a natural phenomenon, or an abstract idea as grouped in Section I, above), it must then be analyzed to determine whether the recited judicial exception is integrated into a practical application of that exception. A claim is not “directed to” a judicial exception, and thus is patent eligible, if the claim as a whole integrates the recited judicial exception into a practical application of that exception. A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.

3. 修改原流程的Step 2A

原本USPTO MPEP 2016的流程圖中，判斷Alice兩步測試法的第一步的Step 2A，被進一步分成兩部分：

(1) PRONG ONE：評估claim是否指向司法例外（Evaluate whether the claim recites a judicial exception）

這部分的修改主要是針對抽象概念的修改，與另兩個司法例外（自然現象或自然法則）無關。

未來如果審查委員認為claim提到抽象概念，必須做以下處理：

A. 指出claim中哪些特定的限制條件提到了抽象概念；

B. 所指出的特定限制條件落入了哪個抽象概念的「群組」。如果特定限制條件落入了某個抽象概念的「群組」，那必須進行第二部分的分析。

[原文] For abstract ideas, Prong One represents a change as compared to prior guidance. To determine whether a claim recites an abstract idea in Prong One, examiners are now to: (a) Identify the specific limitation(s) in the claim under examination (individually or in combination) that the examiner believes recites an abstract idea; and (b) determine whether the identified limitation(s) falls within the subject matter groupings of abstract ideas enumerated in Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance. If the identified limitation(s) falls within the subject matter groupings of abstract ideas enumerated in Section I, analysis should proceed to Prong Two in order to evaluate whether the claim integrates the abstract idea into a practical application. When evaluating Prong One, examiners are no longer to use the USPTO's “Eligibility Quick Reference Sheet Identifying Abstract Ideas,” which has been superseded by this document.

(2) PRONG TWO：如果claim指向司法例外，則判斷司法例外情況是否被整合入實際應用中（If the claim recites a judicial exception, evaluate whether the judicial exception is integrated into a practical application）

這部分三個司法例外操作方法均相同。

依據新的Step 2A，如果特定限制條件落入了某個司法例外（包括前面提到的，抽象概念的「群組」），那必須進行第二部分的分析，判斷該司法例外是否被整合到實際應用之中：

A. 指出claim是否提到額外的要件，使claim超出了司法例外；

B. 運用過去聯邦最高法院與聯邦巡迴上訴法院的考量要素，評估這些額外的要件是否將司法例外整合到了實際應用當中。

[原文] Examiners evaluate integration into a practical application by: (a) Identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations laid out by the Supreme Court and the Federal Circuit, for example those listed below.

其實這個步驟就是原本流程圖中Step 2B所做的判斷，USPTO也承認「評估是否將司法例外整合到了實際應用」就是原本在Step 2B中討論的內容，只是現在挪到Step 2A討論，以提升適格性判斷的效率，並增加確定性與可靠性：

[原文] While some of the considerations listed below were discussed in prior guidance in the context of Step 2B, evaluating them in revised Step 2A promotes early and efficient resolution of patent eligibility, and increases certainty and reliability. Examiners should note, however, that revised Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity. Instead, analysis of well-understood, routine, conventional activity is done in Step 2B. Accordingly, in revised Step 2A examiners should ensure that they give weight to all additional elements, whether or not they are conventional, when evaluating whether a judicial exception has been integrated into a practical application.

USPTO整理出了一些之前聯邦最高法院與聯邦巡迴上訴法院認為將司法例外整合到了實際應用的例子：

• an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field; （參見先前的USPTO 備忘錄 - Recent Subject Matter Eligibility Decisions:  Finjan and Core Wireless (issued April 2, 2018)）
• an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; （參見先前的USPTO 備忘錄 - Recent Subject Matter Eligibility Decision:  Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals (issued June 7, 2018)）
• an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim; 
• an additional element effects a transformation or reduction of a particular article to a different state or thing; 
• an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
• 以下這些則是司法例外和實際應用整合失敗的例子：
• an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
• an additional element adds insignificant extra-solution activity to the judicial exception;
• an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.

由於許多分析被移到Step 2A進行，所以新的適格性審查基準Step 2B只做一件事：判斷claim中其他的要件是不是「眾所周知的、常規的、傳統的 （well-understood, routine, conventional）」。如果是，那麼無法滿足發明概念 （inventive concept）「顯著的更多（significantly more）」要件，所以claim便不適格。

▓　結論

往後撰寫專利說明書時，關於claim標的的適格性，如果涉及司法例外，就必須思考兩個重點：「涉及的司法例外是否被整合到實際應用之中」、「如果是抽象概念，是否被歸類於三個群組之中」。

參考：
https://www.federalregister.gov/documents/2019/01/07/2018-28282/2019-revised-patent-subject-matter-eligibility-guidance