自從美國聯邦最高法院的 Association for Molecular Pathology v Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (Myriad) 一案宣判並公佈以來，已經過了接近一年。美國專利商標局在該判決做成之後緊接著發出簡要通知，要求審查委員暫緩核准在結構上與天然存在之序列相同或類似的DNA序列之相關請求項。

在2014年3月4日，美國專利商標局公佈了如何根據35 USC§101來解讀法定可准專利標的之限制條件的相關新指引。這項指引把Myriad案的判決列入考量，但是也同時考量了最近的其他相關判決。這項通知說明了與標的適格性有關之專利法範疇，特別是在著眼於即將宣判之美國聯邦最高法院案例 Alice v. CLS Bank 一案時，會是如何的難以確認，同時此一指引因係與如何界定抽象概念有關，所以不僅只是針對生物技術領域而已，而是將會影響整個專利法領域。這也就是為什麼對許多專利從業人員來說，目前若不小心應對就可能會落入違反35 USC§101要件的情況。

儘管該指引已如下文所解說的加以擴張，其仍然保留先前所設立之兩部分法律測試方法。隨附的圖表顯示在這些步驟中所應用的測試。

第一個步驟是要確認該請求項是否屬於4種法定專利類別中之一者，或是符合更多項類別。這些類別包含有方法、機器、製品或是物質組成。該指引在第一步驟的分析中並沒有作出多少改變，因此請各位參閱美國專利商標局的MPEP 2105-06，其針對於請求項是否落入這些類別的範例說明仍然是相同的。典型會被排除的範例包含有人類胚胎，以及在美國專利商標局針對請求項之「最寬廣合理解釋」（broadest possible interpretation；BRI）的原則下，會產生典型但屬於可解決問題的「過渡訊號」（例如，任何包含這種訊號的請求項都需要將其明確排除，否則可能無法通過此一測試）。

此一指引的修改內容係適用於第二步驟上。在此之前，第二步驟涉及確認已通過了第一測試之請求項，是否包含了法定不予專利項目，這是屬於美國法院隨著時間演進，透過判例法而確立之一項發明不符合35 USC § 101 規定的理由。此一步驟是要確認該請求項是否與以下事項有關：

• 抽象概念
  
• 自然法則/自然定律
  
• 自然現象
  
• 天然產物

其中，天然產物主要係與生物技術或化學課題有關，而自然法則/自然定律以及自然現象，則與難以在實用發明中所界定之「事物」有關（例如，重力法則或數學常數），然而抽象概念則因為其涉及了心智過程、心智步驟、未具體化之數學公式，以及任何基於請求項內容以及任何方法請求項，並以所欲結果或是數學公式之應用來進行界定的產品請求項，而因此顯得更為重要。

在此指引中所導入之新修改，則與什麼是屬於天然產物（主要是基於Myriad與 Mayo兩案之判決）或是自然法則這些法定不予專利項目有關，並擴大可能會落入這些法定不予專利項目的範疇，特別是DNA序列。

在此指引中的另一項主要修改，係針對於評估一旦落入法定不予專利項目，是否就意味著該請求項之整體內容並不符合35 USC§101的規定。就如同在第一步驟中所應用之「最寬廣合理解釋」（BRI）原則一般，這將會使得任何可能包含這些法定不予專利項目的事物，自動變得不具可准專利性。

因此，此一修改導入了第三步驟，而使得其得以區辨這些內容即使在確實或可能包含一個法定不予專利項目下，是否仍然具有可專利性。該區辨方式係基於該請求項與典型的法定不予專利項目，是否具備「顯著不同」來進行區辨。這一點可以參照上述圖表中之步驟3。

在該指引中，還另外提供了並未排除其他可能而並非窮舉之清單列表，以協助人們確認該請求項是否與法定不予專利項目顯著不同。

在下表中，列出了在該指引中所提出的這些因素：

雖然上述內容顯然並非為窮舉之清單，審查委員仍需要平衡上述所有因素，以確認該請求項是否符合35 USC§101的規定。所有與法定不予專利項目「顯著不同」之「相關證據」，都必須加以考量。

專利適格性就像可據以實現性一樣，係屬於一種大幅度基於事實認定之法律問題，其特別是與該請求項所提出之應用有關。目前還不清楚申請人是否可以透過聲明書（Declarations）來提出關於顯著差異性之申請後證據，以及這些證據可以產生多少影響，又或者這些證據是否應該在提出申請時，便已適當地存在於發明說明書內。

作者： 郭史蒂夫 歐洲專利律師 現任： 北美智權教育訓練處 ／歐洲專利律師 經歷： Bryers事務所 歐洲專利律師 Bugnion SpA事務所 歐洲專利學習律師 Notabartolo & Gervasi事務所 歐洲專利學習律師 歐洲專利局 實習生 英國牛津大學生物化學、細胞與分子生物系，生化碩士 英國倫敦大學瑪莉皇后學院，智財管理碩士

New USPTO guidance on abstract ideas and patent subject-matter eligibility
Stefano John NAIP Education & Training Group / European Patent Attorney

It is nearly a year since the US Supreme Court Decision Association for Molecular Pathology v MyriadGenetics, Inc., 133 S. Ct. 2107 (2013) (Myriad) was reached and made public. Immediately after the decision, the USPTO issued a short notice in which it directed Examiners not to allow any claims directed to DNA sequences if same/similar in structure to naturally occurring sequences.

On the 4th March 2014, the USPTO released new guidance on how to interpret the statutory limit based on 35 USC § 101. This takes into account Myriad, but it also takes into account other recent decisions. The notice also underlines how this area of patent Law regarding subject-matter eligibility is uncertain, especially in light of the upcoming US Supreme Court Case Alice v. CLS Bank and how the guidance affects all areas of patent Law and not only the biotechnology because it is about defining abstract ideas. This is why many patent practitioners are now accidentally falling foul of the 35 USC § 101 requirements.

The guidance retains the 2-part legal test found previously, though it is amplified as explained here below. The accompanying Figure shows the tests to be applied in steps.
The first step is to ask if the claim is directed to one or more of the four statutory categories. These categories are process, machine, manufacture or composition of matter. The guidance does not change much in this first step analysis and therefore the same examples of what is a claim that fits within these categories or not remains the same, see USPTO MPEP 2105-06. Classic examples that are excluded are human embryos and transitory signals, which can cause classical, yet resolvable, problems under the USPTO broadest possible interpretation (BRI) of a claim (for example any claim comprising a signal needs to explicitly exclude transitory signals or it would fail this test).

The change in the guidance applies to the second step. Previously, the second step involved deciding if a claim which had passed the first test comprised a so-called judicial exception – a reason for which US courts have over time and through case-law established means that an invention does not satisfy  35 USC § 101. These were if the claim was directed to:

• Abstract Ideas
  
• Laws of Nature/Natural Principles
  
• Natural Phenomena
  
• Natural Products

Natural products is mainly related to biotechnological/chemical issues and Laws of Nature/Natural Principles and Natural Phenomena are related to “thing” that are difficult to define in a useful invention (for example, the law of gravity or mathematical constant), but abstract ideas is important because it relates to mental processes, mental steps, disembodied mathematical formulas and, depending on their context in the claim, to any method claim, any product claim defined by desired outcome or application of mathematic formulas.

One of the changes introduced in the guidance relates to the judicial exception of what is natural product (mainly in light of Myriad and Mayo) or a Law of Nature and increases the scope of what could fall in such an exception, notably DNA sequences.

The other main change in the guidance is in assessing whether the judicial exception means that the claim, as a whole, should be determined to not satisfy 35 USC § 101. Because of the application of BRI, like for the first step, anything which may include such an exception would automatically not be patentable.

The change is in the introduction of a third step which allows a distinction as to whether it is patentable or not even though it does/may contain a judicial exception in it. The distinction relies on the test if the claim is “significantly different” to classically known judicial exceptions. This can be seen in step 3 of the diagram.

A nonexclusive, non-exhaustive list of factors is provided in the Guidance to help one determine whether the claim is significantly different or not from the judicial exception.
The table below lists these factors as presented in the guidance:

While it is clear that the above are non-exhaustive list, Examiners have to balance all the above factors to decide if the claim satisfies 35 USC § 101 or not. All “related evidence” of being “significantly different” from judicial exceptions must be considered.

Patent eligibility, like enablement, is a legal question heavily based on factual determinations, which are specifically related to the application from which the claims arise. It is unclear if applicant can submit post-filing evidence of significant difference through declarations, and how much weight would those be afforded, or whether the evidence must be provided within the specification proper as filed.

It is however interesting to note that the above factors give some clear incentive to the patent engineer to carefully draft their specification and claim accordingly, especially if one is concerned that the claim may unfairly fall under the judicial exception of 35 USC § 101 as many claims do these days. The clearest advice is to always draft a couple of subsidiary embodiments and/or claims where another element/step which is not a judicial exception is heavily emphasised in the claim. It should be subsidiary so as to be used only if and when necessary – when facing a 35 USC § 101 rejection. Then one can rely on the additional part (see factors (b)-(f) in table and (g)-(l) in the table) to argue that the claim is patent eligible. This may mean losing some monopoly scope in the claim, but at least one obtains a granted claim as opposed to losing the entire claim because at least part of it is considered not patent eligible.

Author: Stefano John, European Patent Attorney Experiences： European Patent Attorney, Bryers Trainee European Patent Attorney, Bugnion SpA Trainee European Patent Attorney, Notabartolo & Gervasi Internship, EPO

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