2015年7月23日 星期四

手段功能用語解釋與結構特徵 - Pressure Products v. Greatbatch (Fed. Cir. 2010)

一般都知道,至少從不少office action可知,裝置範圍的差異應在結構特徵,講過多的功能增進常常都沒有用,最好是能點出這些增進的功能對應的結構改良,有時,在很一般的結構技術都可以獲准專利(如果是達到無法預期的功效),因此這類結構發明不能僅有功能上的差異,特別是審查委員或法官在解釋專利範圍時,常常「更廣地」解釋專利範圍。

不過,這件案例採用的「手段功能用語(means-plus-function)」被CAFC法官用比地方法院更為狹窄的範圍解釋,有趣的是,同樣的法官(部分)在其他案例卻用很廣的方式解釋專利範圍!細節就在這裡。

Pressure Products Medical Supplies, Inc. v. Greatbatch Ltd. (Fed. Cir. 2010)

案件資訊:
原告(專屬被授權者):PRESSURE PRODUCTS MEDICAL SUPPLIES, INC.,
侵權被告/上訴人:GREATBATCH LTD. (doing business as Enpath Medical, Inc.)
系爭專利:US5,125,904、US5,312,355

地院階段:
地方法院在侵權訴訟審理中的專利範圍解釋上,被告提出專利無效的請願(motion for JMOL),經駁回請願,並判斷侵權成立後,侵權被告Enpath提出上訴。

被告產品如下(影像來自判決書):
Enpath’s FlowGuard™ introducer product (“FlowGuard™”)

ViaSeal™ prototype introducer product (“ViaSeal™”)


CAFC階段:
法官根據系爭專利的記錄,認為並未支撐地方法院解釋的專利範圍,提出新的專利範圍解釋,但是仍認同地院駁回被告請願的決定,於是發回地院重審,並重新審理侵權議題。

系爭專利有關外科手術在血管中的導引裝置,是一種可以方便外科醫生置放與取出導管的裝置,其中有一種止血閥,可以調解在手術中流動的血液。問題是,當醫生要取出導管時,習知技術採用分離式或可剝離式的sheath(鞘),卻不容易也將止血閥取出,合理地知道,當另外取出止血閥時,會造成失血的狀況,系爭專利對此提出,透過分離式的裝置同時將止血閥與前述的sheath一併取出,如以下各專利圖式,圖1為系爭專利的設計,而圖3為分離取出止血閥與sheath的樣態。

系爭專利:
US5,125,904
1. An sheath assembly for use with a lead or catheter comprising:
an introducer sheath;
a hemostatic valve coupled to said introducer sheath, said hemostatic valve and introducer sheath being arranged and configured to permit introduction of at least one lead or catheter therethrough;
means for permitting removal of said hemostatic valve and introducer sheath from said lead or catheter disposed therethrough without requiring said introducer sheath and hemostatic valve to be removed from an end of said lead or catheter,
whereby said assembly may remain in a vein throughout an operation with the advantage of free lead exchange and easier lead manipulation without substantial bleeding, risk of air embolism, clotting or repeated sheath insertion related trauma from lead exchange.
US5,312,355

1. A sheath assembly for use with a lead or catheter comprising:
an introducer sheath;
a hemostatic valve coupled to said introducer sheath, said hemostatic valve and introducer sheath being arranged and configured to permit introduction of at least one lead or catheter therethrough;
means for permitting removal of said hemostatic valve and introducer sheath from said lead or catheter disposed therethrough without requiring said introducer sheath and hemostatic valve to be removed from an end of said lead or catheter,
wherein said means for permitting removal of said hemostatic valve comprises a two-part body, said two-part body being made in two separate body portions, said body portions defining means for sealing said body portions together when said two body parts are joined with each other to form said hemostatic valve,
whereby said assembly may remain in a vein throughout an operation with the advantage of free lead exchange and easier lead manipulation without substantial bleeding, risk of air embolism, clotting or repeated sheath insertion causing related trauma from lead exchange,

簡單來看,"means"自然符合35USC112(f)解釋為means-plus-function的假設(雖然部落格也曾討論過means不代表一定是means-plus-function,不過這樣想仍是通例),CAFC法官於是參考系爭專利說明書所描述的結構特徵,如:"score lines defined in the hemostatic valve and introducer sheath, and equivalents thereof.",其中"score lines"被解釋為"一或多個在止血閥與鞘內的線"。

接著就是被告侵權物是否被專利範圍所讀入,包括以上means-plus-function的解釋,不同於地方法院陪審團"恣意"解釋"score lines",以及判斷侵權成立的決定,甚至作出1.1百萬美元的賠償決定,其實地方法院在進行解釋時已經參考專家意見,以及原告與被告雙方的意見,甚至被告曾經同意地院作出的解釋。不過,這些意見在CAFC都有不同的看法,CAFC法官認為地方法院解釋專利範圍時仍應回歸專利審查歷史與字典解釋。

再來是「功能手段用語」的「等效範圍」,原告Pressure Products主張claim 1仍可包括先前技術所未揭露的範圍,但法院糾正這個想法,認為法官對於手段功能用語的範圍已經包括明確描述在說明書內以外的結構,確認如上解釋:"score lines defined in the hemostatic valve and introducer sheath, and equivalents thereof."。

地院解釋專利範圍時,認為等效範圍可以涵蓋「習知技術並未揭露的部分」。

CAFC採用的解釋:

(另有一些不正當行為辯護(inequitable conduct defense)的法律議題,不在這裡討論)

最後,由於CAFC認為地院解釋專利範圍有誤,發回重審。


CAFC判決:
http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1602r.pdf

備份:
https://app.box.com/s/mk73l8fi8um64c3970my2y4t14wt7vbe

Ron

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