... a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. ...
http://www.supremecourt.gov/opinions/13pdf/13-369_1idf.pdf（更新連結, updated on Dec. 2, 2015）
（備份：https://app.box.com/s/ban85o7omndymewu3xykg2nooyk2s92j）
事實上，專利寫作在不明確與明確之間有個不明確的界限，這常是專利寫作的人（專利工程師）自己斟酌，而且也是專利實務上通常保持寬容態度的部份，原則是讓相關技術的一般技術人員可以明瞭與據以實施。但如果這個部份一旦被挑戰或是定下嚴格或是更寬鬆的規範，可能會產生不小的討論/震動。
這個涉及"明確性definiteness"模糊地帶的最高法院案例似乎想要糾正我們（或說是CAFC）對於明確的定義，特別是美國這個多數時候對權利範圍解釋極為寬容的國家，顯然如其他最高法院判例一般，會影響我們專利的寫作態度。
明確性：
對於明確的要求，主要法條在112第二段，還有不少關於明確性的審查標準，如MPEP 2173系列。
35 U. S. C. §112, 2nd paragraph.
The Patent Act requires that a patent specification “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as [the] invention.”
MPEP 2173.02
The essential inquiry pertaining to this requirement is whether the claims set out and circumscribe a particular subject matter with a reasonable degree of clarity and particularity. Definiteness of claim language must be analyzed, not in a vacuum, but in light of:
(A) The content of the particular application disclosure;
(B) The teachings of the prior art; and
(C) The claim interpretation that would be given by one possessing the ordinary level of skill in the pertinent art at the time the invention was made.
案例討論：
案例NAUTILUS, INC. v. BIOSIG INSTRUMENTS, INC. 中，Biosig Instruments, Inc.擁有專利US5,337,753，其中界定一個用在運動器材的心臟監測儀，宣稱比過的心臟監測儀更準確，理由是該發明可以排除人體骨骼肌肉所產生的干擾訊息，影響心臟的訊號量測。
這個心臟監測儀由結構與電路定義，結構為細長的空心圓筒形狀，其表面佈有電路，圓筒兩端設有電極，用以偵測肌電圖信號 （electromyogram signals ），這個肌電圖信號為取得心臟訊號時利用差分放大器要排除的干擾訊號，最後就僅會輸出心電圖信號。
不過，專利爭議在於權利範圍是否"明確"！
主要技術如該案Claim 1：
1. A heart rate monitor for use by a user in association with exercise apparatus and/or exercise procedures, comprising;
an elongate member;
electronic circuitry including a difference amplifier having a first input terminal of a first polarity and a second input terminal of a second polarity opposite to said first polarity;
said elongate member comprising a first half and a second half;
a first live electrode and a first common electrode mounted on said first half in spaced relationship with each other;
a second live electrode and a second common electrode mounted on said second half in spaced relationship with each other;
said first and second common electrodes being connected to each other and to a point of common potential;
said first live electrode being connected to said first terminal of said difference amplifier and said second live electrode being connected to said second terminal of said difference amplifier;
a display device disposed on said elongate member;
wherein, said elongate member is held by said user with one hand of the user on said first half contacting said first live electrode and said first common electrode, and with the other hand of the user on said second half contacting said second live electrode and said second common electrode;
whereby, a first electromyogram signal will be detected between said first live electrode and said first common electrode, and a second electromyogram signal, of substantially equal magnitude and phase to said first electromyogram signal will be detected between said second live electrode and said second common electrode;
so that, when said first electromyogram signal is applied to said first terminal and said second electromyogram signal is applied to said second terminal, the first and second electromyogram signals will be subtracted from each other to produce a substantially zero electromyogram signal at the output of said difference amplifier;
and whereby a first electrocardiograph signal will be detected between said first live electrode and said first common electrode and a second electrocardiograph signal, of substantially equal magnitude but of opposite phase to said first electrocardiograph signal will be detected between said second live electrode and said second common electrode;
so that, when said first electrocardiograph signal is applied to said first terminal and said second electrocardiograph signal is applied to said second terminal, the first and second electrocardiograph signals will be added to each other to produce a non-zero electrocardiograph signal at the output of said difference amplifier;
means for measuring time intervals between heart pulses on detected electrocardiograph signal;
means for calculating the heart rate of said user using said measure time intervals;
said means for calculating being connected to said display device;
whereby, the heart rate of said user is displayed on said display device.
看到這麼冗長的權利範圍，首先想到的是範圍應該不大，而且應該不會有不明確的問題。
專利權人以此案對Nautilus Inc.提出專利侵權訴訟。
在地方法院階段，簡易判決中同意被告對權利範圍中的"in spaced relationship with each other"的描述不明確。不過經專利權人上訴CAFC後，法官認為權利範圍並沒有無法解決的模糊(insolubly ambiguous)，因此駁回地方法院的決定。
CAFC的態度是如果請求項的範圍根據說明書內容與審查歷史（內部證據）都無法讓相關技術人員了解發明的範疇，才可以因為不明確而無效專利；另一個主要態度是，除非是權利範圍有無法解決的模糊（insolubly ambiguous），否則在權利範圍可以經得起解釋時（可以被解釋時），不能排除具有明確性的可能。(updated on Feb. 16, 2016)
"1. A patent is invalid for indefiniteness if its claims, read in light of the patent’s specification and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Section 112’s definiteness requirement must take into account the inherent limitations of language.
2. The Federal Circuit’s standard, which tolerates some ambiguous claims but not others, does not satisfy the statute’s definiteness requirement. The Court of Appeals inquired whether the '753 patent's claims were "amenable to construction" or "insolubly ambiguous,“ but such formulations lack the precision 112, second paragraph demands."(updated on Feb. 16, 2016)
CAFC判斷根據主要是源自多個案例，其表明明確定定義應該是：
不過，CAFC更用更寬容的態度來界定明確性，表示其對於112條明確性判斷是，若Claims為經得起解釋（Amenable to Construction），並非是無法解決的模糊（insolubly ambiguous），因此判斷權利範圍仍為明確。（以上用語是我的翻譯，不盡到位，敬請指教）(updated on Feb. 16, 2016)
According to the Federal Circuit, a patent claim passes the §112, ¶2 threshold so long as the claim is amenable to construction,” and the claim, as construed, is not “insolubly ambiguous.”
...
In resolving Nautilus’ definiteness challenge, the Federal Circuit asked whether the ’753 patent’s claims were “amenable to construction” or “insolubly ambiguous.”
進入最高法院。
主要爭議還是在侵權被告Nautilus所提出系爭專利所界定出的裝置上的電極位置關係不明確，而且Claim所描述的關聯有太多解釋方式（編按，這不就是Claim的用意嗎？）；專利權人Biosig回應根據說明書、圖示等揭示內容已經足夠精確地瞭解專利範圍。
其中最高法院對此案例也表示他們並非是要宣告一個明確性的新標準，只是反對CAFC訴諸一個沒有定向的判斷標準。
最高法院駁回CAFC對於不明確的認定，認為CAFC容忍的不明確並沒有滿足明確性的要求（We conclude that the Federal Circuit’s formulation, which tolerates some ambiguous claims but not others, does not satisfy the statute’s definiteness requirement.）。因此認為'753專利是否符合明確的判斷如果採用了"insolubly ambiguous“作為是否不明確的認定是錯誤的指引，甚至用"滲透"整個CAFC判斷明確性的判決來描述嚴重性。
最高法院的態度其實沒有新意，但卻導正CAFC有些偏差的判斷原則（直指insolubly ambiguous）：
"In place of the “insolubly ambiguous” standard, we hold that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention."
最高法院法官提到專利的基本定義，就是政府提供發明人一段時間內的獨佔權（limited monopoly），因此專利揭露以及要求某個範圍的獨占性時，包括其目的是要與先前技術區隔，其範圍的"邊界"理應清楚，專利在考量了說明書、審查歷史等仍無法讓相關技術人員可以瞭解專利範圍時，認定為不明確（這回歸一般原則）。特別是案例中系爭專利'753專利為一種改良型專利，在範圍的界定上應該更為明確。(updated on Feb. 16, 2016)
最後決定：
案件發回CAFC重審，並要求以最高法院的意見作為裁決的依據。
Ron
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