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。
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)。
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:
Factors that weigh toward eligibility (significantly different)
Factors that weigh against eligibility (not significantly different)
a) Product claim recites something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.
g) Product claim recites something that appears to be a natural product that is not markedly different in structure from naturally occurring products.
b) Other elements/step in addition to judicial exception impose meaningful limits on the claim scope.
h) Other elements/step in addition to judicial exception are recited at a high level of generality.
c) Other elements/step in addition to judicial exception relate to the judicial exception(s) in a significant way, e.g., they are more than insignificant extra-solution activity.
i) Other elements/step in addition to judicial exception must be used/taken by others to apply the judicial exception(s).
d) Other elements/step in addition to judicial exception impose do more than describe the judicial exception(s) with general instructions to apply/use it.
j) Other elements/step in addition to judicial exception are well-understood, purely conventional or routine.
e) Other elements/step in addition to judicial exception include a particular machine or particular transformation, which implements or integrates the judicial exception(s).
k) Other elements/step in addition to judicial exception are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s).
f) Other elements/step in addition to judicial exception add a feature that is more than well-understood, purely conventional or routine.
l) Other elements/step in addition to judicial exception amount to nothing more than a mere field of use.
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