「device」就是裝置嘛！？偏偏就是有文章。編按，與其說是討論"device"怎麼解釋，還不如說是討論解釋專利範圍時，特定用語將可能受限於說明書、圖式、審查歷史的主張，況且本案中處處都限定「device」為何，無法說服人可以更寬廣地解釋這個東西。
案件資訊：
原告/被上訴人：BRUCE N. SAFFRAN, M.D., PH.D. ("Saffran")
被告/上訴人：JOHNSON & JOHNSON AND CORDIS CORPORATION ("Cordis")
系爭專利：US5,653,760
本案緣起東德州地方法院判決被告Cordis侵權成立，經被告上訴後，CAFC判定地方法院錯誤解釋專利範圍，重新解釋專利範圍，並判定侵權不成立。
系爭專利US5,653,760關於一種管理大分子分布的技術，這是一個治療骨折的裝置，特別針對有破碎式骨折的狀況，通過抑制小分子而助長大分子，Claim 1界定一種彈性固定裝置，用在治療人類或動物組織損害的用途，裝置包括有孔的彈性材料層，可以折成立體的樣子，其中第一主要表面放在受損組織旁，第二主要表面放在受損組織相對位置上，其中有個「釋放手段」，可以將材料"具有方向性地"通過立體結構釋放到受損組織的一旁。
1. A flexible fixation device for implantation into human or animal tissue to promote healing of a damaged tissue comprising:
a layer of flexible material that is minimally porous to macromolecules, said layer having a first and second major surface, the layer being capable of being shaped in three dimensions by manipulation by human hands,
the first major surface of the layer being adapted to be placed adjacent to a damaged tissue,
the second major surface of the layer being adapted to be placed opposite to the damaged tissue,
the layer having material release means for release of an at least one treating material in a directional manner when said layer is placed adjacent to a damaged tissue,
the device being flexible in three dimensions by manipulation by human hands,
the device being capable of substantially restricting the through passage of at least one type of macromolecule therethrough.
Claim 8界定治療受損骨頭的方法，裝置部分的描述與Claim 1一樣。
8. A method of treating a damaged tissue to promote repair comprising:
a) providing a device including, a layer of flexible material that is minimally porous to macromolecules, said layer having a first and second major surface, the layer being capable of shaping in three dimensions by manipulation by human hands,
the first major surface of the layer being adapted to be placed adjacent to the damaged tissue,
the second major surface of the layer being adapted to be placed opposite to the damaged tissue,
the layer having material release means for release of an at least one treating material in a unidirectional manner when said layer is placed adjacent to the damaged tissue,
the device being flexible in three dimensions by manipulation by human hands,
the device being capable of restricting the through passage of at least one type of macromolecule therethrough,
b) placing the device adjacent to a damaged tissue,
c) whereby the placed device results in directional presentation of the at least one treating material.
專利實施的樣子如下，將材料噴塗在受損的骨頭上，所謂的裝置，相對於習知可自由進出的孔洞，可以具有方向性地遞送藥劑，可以水分子呈現在治療的區域上。
被告侵權物為Cordis的Cypher®，這是一種支架，其中具有微聚合物層的金屬網包覆在支架上，但根據網路上的資料顯示在2011年已經停產（地院判決那年），即便訴訟在2013年贏了。
在地院訴訟過程，解釋專利範圍時，作出以下幾個解釋：
(1) 對於請求項中「device」作出解釋：認為「device」這個在申請專利範圍「前言」中的用語僅是提出一個作為請求項內容限制的名稱（"a device having the limitations called out by the body of the claim"），意思是，系爭專利範圍中的"device"不是有形體的裝置，而是指出專利範圍的名稱（代名詞）。
"The district court first addressed the term “device,” which it viewed as nonlimiting preamble language that “merely gives a descriptive name to the set of limitations in the body of the claim.”"
(2) 將申請專利範圍中「到大分子的微孔（"minimally porous to macromolecules"）」解釋為實質上不透水的大分子（"substantially impermeable to macromolecules"）。
(3) 將「在一個方向釋放治療材料的手段（"means for release of at least one treating material in a directional manner"）」以手段功能用語解釋，說明書對應的結構特徵是「化學鍵與鏈結」。
"“means for release” is “to release a drug preferentially toward the damaged tissue” and
defined the corresponding structures disclosed in the ’760 patent’s specification as “chemical bonds and linkages.”"
如此，地院判決"蓄意"侵權成立，以及判決一個為數不小的損害賠償。
案件經上訴到CAFC，解釋專利範圍的議題圍繞在「device」與「release means」的解釋。
這裡討論「device」的解釋：
「device」出現在系爭專利的每個請求項中，被告根據說明書內容，主張「device」並非如地院解釋僅為「前言」中涵蓋專利範圍的一個描述用語而已，而是指一個有形有體的連續薄片（continuous sheet），這個薄片（sheet）是用來隔離傷口附近大分子，並說明沒有覆蓋的網孔的支架（如上被告物品圖示）不能防止大分子進出。加上系爭專利審查過程也為了要區隔先前技術的「開放式網孔支柱（"open mesh stents"，這也剛好是被告產品的特徵）」而強調這個「device」就是一個可以隔離大分子的連續薄片。
顯然，解釋系爭專利「device」受限於說明書內容（包括圖式）與答辯歷史，無法擴及僅是功能性描述的專利特徵，而需要限定在有形有體的連續薄片上。
"We conclude that Saffran’s statements during prosecution of the ’760 patent limit “device” to a continuous sheet."
"... construe the term “device,” as used in the claims of the ’760 patent, to mean a continuous sheet andto exclude stents having open mesh holes."
根據CAFC查驗系爭專利審查歷史，確認系爭專利答辯時曾作出「device」為一薄片的解釋，並且被告產品並非連續薄片，有支架網孔。CAFC結論，同意被告主張，經過以上元件與相關專利範圍解釋，侵權不成立。
判決書：
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/12-1043.Opinion.4-1-2013.1.PDF（備份：https://app.box.com/s/fs04fdfgqnl4kvt4btm23xdfh5eafj2v）
my two cents:
本案例的資訊是來自工業技術研究院「從美國訴訟淺談專利撰寫答辯及請求項用語解釋研討會」的議程所揭示的內容。
Ron
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