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2026年9月1日 星期二

普通觀察者是否被欺瞞的設計侵權判斷原則 - Egyptian Goddess, Inc. v. Swisa, Inc. (Fed. Cir. 2008)

[前言]
本篇討論關於判斷設計專利與被告設計之間差異的標準的經典案例「Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665 (Fed. Cir. 2008)」,那為何要研究本案?

下篇要討論的 - Range of Motion Products, LLC v. Armaid Company Inc. (Fed. Cir. Feb. 2, 2026,此案在CAFC En Banc聯席法官否決複審(The petition for rehearing en banc is denied)後,確立CAFC在Feb. 2, 2026的判決,其中特別引用本篇Egyptian判決。

判斷設計侵權的步驟簡單地說就是先確認設計專利範圍,也就是基於本篇討論的案例 - Egyptian Goddess Inc. v. Swisa, Inc. (Fed. Cir. 2008)的判決意旨:比起文字描述,設計範圍的解釋較佳地是基於圖面(illustration)的表示,判斷設計侵權與否,則以普通觀察者(定義為熟悉先前設計的人/消費者)的眼光判斷是否造成混淆來斷定

"a design is better represented by an illustration ‘than it could be by any description and a description would probably not be intelligible without the illustration."



另一理由是,因為發現原本想要理解的前例(即Litton Systems, Inc. v. Whirlpool Corp. (Fed. Cir. 1984)被此案例某種程度的"否決",因此就來看看,這都是想要涵蓋各種案例(企圖如此)的本部落格漏掉的一塊。

參考本案例之前的"前例":
- 1871年確立"一般觀察者"的設計侵權判斷標準與討論 - Gorham v. White (Supreme Court 1871)https://enpan.blogspot.com/2016/01/1871-gorham-v-white-supreme-court-1871.html

其中提到:
"1984年CAFC案例Litton v. Whirlpool認為1871最高法院建立的「ordinary observer」是否有混淆(消費者購買侵權物誤認為購買具有專利的產品)的侵權判斷標準並不足夠,而是應該要確認設計專利相較於先前技術「具有新穎性的部分」是否有混淆來進行侵權比對。"

- 1984年確立「新穎特徵基準」案例 - Litton Systems, Inc. v. Whirlpool Corp. (Fed. Cir. 1984)https://enpan.blogspot.com/2026/08/litton-systems-inc-v-whirlpool-corp-fed.html

其中提到:
"縱使法院參考Groham前例以普通觀察者的眼光比較設計與產品,但為了確認侵權,法院還是引入了「新穎特徵」( "point of novelty" approach的判斷方法,也就是普通觀察者判定的"相似性"仍應基於這個新穎特徵來判斷。"

基於前述兩個先例,本案例提出新的見解(否決新穎特徵測試),也是目前主流判斷原則,先提出本案在rehearing en banc結論:



[本篇rehearing en banc案例報導]
案件資訊:
原告/上訴人/設計專利權人:EGYPTIAN GODDESS, INC. (EGI)
被告/被上訴人:SWISA, INC. and DROR SWISA
系爭設計:D467,389

EGI的系爭設計'389為一種磨指甲/拋光的工具(nail buffer),特別如下圖顯示是中空管狀方形內徑的工具,因為美國設計專利通常不用太多的文字說明,以圖為準,但法院審理時仍提供了文字解釋,甚至尺寸細節都估計出來:


在地院階段,兩個議題:系爭設計無效爭議與侵權爭議。地院判決被告Swisa並未證明系爭設計拋光工具的外觀是由其實用目的所支配(dictated by its utilitarian purpose),因此地院判決系爭專利有效。而對於被告提起侵權不成立簡易判決(summary judgment of non-infringement)請願,地院引用前例要求原告需證明:(1)以“普通觀察者”(ordinary observer test)眼光,認知被告侵權產品與系爭設計實質相似;(2)被告侵權產品“實質相同”系爭設計能區隔先前技術的“新穎特徵”(point of novelty)。

根據上述兩點,地院判決被告侵權產品並沒有涵蓋系爭設計的“新穎特徵” -- 上述系爭設計圖案中「拋光工具裸露出沒有被磨砂層覆蓋的第四面」,因此侵權不成立。

EGI上訴CAFC,CAFC同意地方法院的侵權不成立的判決 - 沒有事實證明Swisa產品使用了系爭設計的新穎特徵

甚至CAFC還進一步解釋「新穎特徵/point of novelty」可以是單一設計元素,或是一些習知設計分別具備的元素的新的組合,而此組合並非是微不足道的。


在此新穎特徵的攻防中,原告EGI列出幾項特徵的組合(如:開放與中空主體、正方形截面、隆起的長方形磨具、暴露出的角落等),法院進一步與先前技術(Nailco)比對從中得出新穎特徵 - 長方形主體(編按這裡判決文好像有錯,寫成三角形),而又認為陪審團不會認同說這個新穎特徵相對先前設計是重大的進步(non-trivial advance)。

經考量先前技術判定的非重大進步("non-trivial advance"test),CAFC認為被告侵權產品與系爭設計的差異並非微小(Swisa拋光器是四面都有磨具),因此同意地院判決而判決侵權不成立。

CAFC於2007判決:

然而,本案進入en banc(原告提CAFC複審請願被否決),但en banc同意審理,參考CAFC提出反對意見的法官DYK,見解如下:DYK不同意採用"non-trivial advance"測試作為設計基於新穎特徵的侵權判斷方法,認為這個測試與前例不一致,也沒有支持的前例,且混淆了侵權標準與設計顯而易見性的判斷,DYK認為
"non-trivial advance"測試僅針對有多個元素組合的設計,在本案不是拿來評估"設計整體"的顯而易見性,而是不當地用於評估"每個新穎特徵"的顯而易見性。


據此,法院受理rehearing en banc(全院聯席重審),各方提出幾個議題:
1. 是否要繼續使用「新穎特徵」檢視設計侵權案?
2. 是否法院應採用"non-trivial  advance test"作為判斷是否特定設計特徵為"新穎特徵"的手段?
3. 如何進行新穎特徵測試?特別是當設計的複數個特徵不同於先前設計時。
4. 是否地方法院在審理設計專利案時應執行正式的專利範圍解釋?

en banc對各議題的意見:

1. 是否要繼續使用「新穎特徵」檢視設計侵權案?

法院參照案例Gorham Co. v. White, 81 U.S. 511 (1871)意旨,分析設計專利侵權,就看設計的外觀,其中線條、結構上的細微差異都不影響實質的相同/不相同。視覺效果的一致性就是判斷兩個設計是否實質相同的主要標準("sameness of effect upon the eye, is the main test of substantial identity of design")。


可參考:1871年確立"一般觀察者"的設計侵權判斷標準與討論 - Gorham v. White (Supreme Court 1871)(https://enpan.blogspot.com/2016/01/1871-gorham-v-white-supreme-court-1871.html

法院也提到前例Litton的判決:不僅要以普通觀察者查看設計的相似度,也要得出特定新穎特徵,但en banc認為判斷設計的新穎特徵不容易,特別是在設計往往是由多個特徵組成,並不容易逐一判斷是否為設計的新穎特徵

可參考:1984年確立「新穎特徵基準」案例-Litton Systems, Inc. v. Whirlpool Corp. (Fed. Cir. 1984)(https://enpan.blogspot.com/2026/08/litton-systems-inc-v-whirlpool-corp-fed.html

法院藉此案讓大家重新考量使用「新穎特徵」的侵權判定方式,新穎特徵判斷與普通觀察者測試是平行的方式,也就是沒有需要兩段式判斷侵權案件。

編按,兩段式是,普通觀察者查看設計外觀是否有欺瞞消費者以為購買了某一來源的商品;再看被告商品是否具有設計專利的新穎特徵。

2. 是否法院應採用"non-trivial  advance test"作為判斷是否特定設計特徵為"新穎特徵"的手段?

基於被告Swisa認為法院不能拋棄新穎特徵測試,但法院(en banc)不同意,只不過最終判決仍是對被告有利的結果。

法院(en banc)明確表示不使用non-trivial advance test,而這是新穎特徵測試(point of novelty test)的進一步測試,都不再使用,僅採用普通觀察者的測試法則。


本議題後面一段也頗為精彩,談到可能訴訟雙方都會尋求對自己有利的判斷法則,就討論到舉證責任,不翻譯了,呈現精彩原文:



3. 如何進行新穎特徵測試?特別是當設計的複數個特徵不同於先前設計時。4. 是否地方法院在審理設計專利案時應執行正式的專利範圍解釋?(一起理解)

不同於發明專利解釋專利範圍,其實法院並沒有被要求要解釋設計專利範圍,特別如美國最高法院已經認知設計最好的解釋就是看繪製的外觀,不會去特別解釋說明描述,也如同專利審查過程解釋設計專利範圍的方式。

"Given the recognized difficulties entailed in trying to describe a design in words, the preferable course ordinarily will be for a district court not to attempt to “construe” a design patent claim by providing a detailed verbal description of the claimed design."

但實務上,地方法院階段是由陪審團解釋專利範圍,雖然解釋設計的描述可能並不明智,但向陪審團描述法院自己的分析對於設計侵權判斷其中各種設計特徵仍有幫助。這裡特別列舉本案,可參考以下各圖比對,法院可以向陪審團指出設計特徵,如本案系爭設計只有三個面有磨具(拋光用的結構),但被告產品則四面都有磨具,還可指出先前設計(Falley、Nailco)的結構特徵。

下圖為法院將已知前案與被告商品(Swisa Buffer)與系爭設計('389)並排比較。


確實以上針對設計說明的解釋是對理解設計有幫助,但en banc仍認為對於設計專利的解釋,法院不應如以上逐字理解來解釋設計專利範圍。這當然跟法院僅採用普通觀察者的眼光來看設計是否侵權的方法有關。

法院進一步定義「普通觀察者/一般觀察者/ordinary observer」,並非是對此設計(磨指甲/拋光的工具(nail buffer))一概無知的人,而是對此類產品(先前的設計)有一定熟悉的消費者,也就是已經熟悉這裡提到的兩件先前設計-Falley與Nailco的普通觀察者。

en banc結論:
en banc採用不同於CAFC/地方法院的方法(需基於先前技術判斷新穎特徵的non-trivial advance test),而是以普通觀察者的測試方法(regular observer test,回歸Gorham法則)判定侵權不成立(無須先判斷新穎特徵),但沒有否認CAFC的方法,認為兩者是平行的測試方法。

然而,en banc"似乎"也承認/無法否定這件案子一脈相承都是先比對先前技術得出系爭設計的新穎特徵再判斷是否被告侵權產品有此新穎特徵來判斷侵權與否,使得即便en banc判定設計侵權僅會採用普通觀察者法則,即便採用不同的方法,仍同樣地判斷兩個設計之間差異不能說不小而判定侵權不成立。


一個熟悉先前設計的消費者(買者)沒有因為設計專利與被告設計的相似度而被欺瞞/誤認以為買了某一來源(原本想買)的產品,因此判定侵權不成立。


my two cents:
以上結論很簡單,產品設計是否有侵害某設計專利權,就以普通觀察者來看兩者的差異是否會造成購買商品的人誤認以為買了某來源的商品,而無須根據先前技術先判斷出新穎特徵,再以新穎特徵來確認被告商品是否有此特徵。

設計是否有專利性(新穎性、非顯而易見性等)的判斷不同侵權判斷,直接參考MPEP 1504 Examination,取得設計專利的要件須考量:裝飾性(ornamentality)、新穎性(novelty)、非顯而易見性(nonobviousness)、可實施性(enablement)與明確性(definiteness)。(參考:https://www.uspto.gov/web/offices/pac/mpep/s1504.html

其中需要先判斷設計申請案的裝飾性特徵,所謂設計是針對裝飾目的的設計,而非針對功能或機構上的產品。設計專利權僅授與whoever invents any new, original, and ornamental design for an article of manufacture。也就是取得設計專利,要具備新穎且非顯而易知的裝飾性特徵,而此裝飾特徵還是要從設計整體來看,也就設計的主軸是以裝飾為出發點(primarily ornamental),並不是將設計拆解後分別功能性與裝飾性特徵,因此以實用性為出發點的產品外觀一般裝飾性並不強

"A determination of ornamentality is not a quantitative analysis based on the size of the ornamental feature or features but rather a determination based on their ornamental contribution to the design as a whole."


Ron

2026年8月4日 星期二

「type」用語形成不明確 - MPEP 2173.05(b)

MPEP 2173
...
2173.05(b) Relative Terminology
...
E.“Type”

The addition of the word “type” to an otherwise definite expression (e.g., Friedel-Crafts catalyst) extends the scope of the expression so as to render it indefinite. Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). Likewise, the phrase “ZSM-5-type aluminosilicate zeolites” was held to be indefinite because it was unclear what “type” was intended to convey. The interpretation was made more difficult by the fact that the zeolites defined in the dependent claims were not within the genus of the type of zeolites defined in the independent claim. Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986).

-------------------------------------------------------
根據以上提到「type」相對用語,在一個明確的用語上加上"type"會擴大解釋範圍而使其變的不明確

案例一:Ex parte Copenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955)

例如元件「Friedel-Crafts catalyst」改寫為「Friedel-Crafts type catalyst」,將形成不明確的範圍。

查Google Patents得到US2882305 ,關於一種有機膦酰鹵化物的生產方法:https://patentimages.storage.googleapis.com/10/77/03/ddc8e79d640be7/US2882305.pdf



案例二:Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986)

此案例中有個元件「“ZSM-5-type aluminosilicate zeolites”(ZSM-5型鋁矽酸鹽沸石)」被判定是不明確,理由是加上了"type"這個字。並且,當在附屬請求項中定義元件「沸石(zeolites)」,卻非落於獨立請求項中的沸石類型(genus of type of zeolites)中,這讓專利範圍解釋更加困難。



Ron

2026年7月28日 星期二

「摘要」的筆記 - MPEP 608.01(b)

MPEP 608.01(b) Abstract of the Disclosure

其中規定:
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “This disclosure concerns,” “The disclosure defined by this invention,” “This disclosure describes,” etc.

規定摘要文字要清楚與簡潔,不應重複專利名稱(the title)已經給予的資訊,應避免使用"暗示(implied)"用句,如"this disclosure concerns", "the disclosure defined ..."與"this disclosure describes ..."。

甚至有些審查委員認為"are provided"都是屬於暗示用語,不准寫。

多數審查委員不能接受的是"disclosure is ..."、"is disclosed"、"the disclosure concerns"這類用語。


又在6.16節補充:
6.16 Abstract of the Disclosure: Language 
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet preferably within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. Examiner Note:

補充要避免Claim中的法律用語,如means, said等。


Ron

2026年7月15日 星期三

提交證據反駁核駁理由 - MPEP 716、37 CFR 1.132

37 CFR 1.132
Affidavits or declarations traversing rejections or objections. When any claim of an application or a patent under reexamination is rejected or objected to, any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration under this section. (https://www.uspto.gov/web/offices/pac/mpep/mpep-9020-appx-r.html#d0e323552)

MPEP 716 Affidavits or Declarations Under 37 CFR 1.132 and Other Evidence Traversing Rejections(https://www.uspto.gov/web/offices/pac/mpep/s716.html

當專利申請案或在複審(reexamination)的專利被核駁(rejection)或因瑕疵被異議(objection),申請人除了一般回應(答辯、修正)外,還可以宣誓或聲明(declaration)方式提交「證據」回應審查意見,審查委員將審視這些證據判斷是否克服核駁或異議意見。

審查委員審視宣誓與證據後,可能回應:已克服審查意見、不足以克服審查意見與相關理由。

提交宣誓/聲明與證據的時機:
(1)接獲最終核駁意見(final office action)之前,若是針對核駁意見,第一次office action就應提交證據。
(2)非最終核駁意見的情況下提出訴願(appeal)之前。
(3)最終核駁意見之後,但在提出訴願之前。
(4)在審查程序關閉後(after prosecution is closed,如final rejection後、訴願後、核准後),若申請人提出接續審查請求(RCE)時。

審查委員是否會考量證據的判斷:
若符合上述時機提出的宣誓/聲明與證據,審查委員都應考量。若證據不足以克服審查意見,審查委員會提出解釋。

註解:
所提出的證據一般是針對非顯而易見性的議題,如證明發明非可預期的結果(unexpected result)、商業上的成功(commercial success)、解決長期需要但未解決的問題(long-felt but unsolved needs)、他人並未成功實現的發明(failure of others),或是解決專家的質疑(skepticism of experts)等所謂輔助性因素(‘secondary considerations’)。(細節可參考:https://www.uspto.gov/web/offices/pac/mpep/s716.html

從以上筆記可知,提交證據一般是針對非顯而易見性的議題,特別地,關於證據本身的要求還有:客觀的證據;"nexus requirement",也就是與申請專利範圍連結(nexus)的證據。

Ron

2026年7月13日 星期一

「摘要」的摘要-MPEP 1826與WIPO

之前的"摘要":
- 有關摘要的撰寫規定 - 筆記&範例(https://enpan.blogspot.com/2020/04/blog-post.html
- 摘要的撰寫 - 避免言外之意(https://enpan.blogspot.com/2018/02/blog-post.html

先看一下MPEP 608.01(b)(直接跳到這個章節-https://www.bitlaw.com/source/mpep/608-01-b.html):
(b) A brief abstract of the technical disclosure in the specification must commence on a separate sheet, preferably following the claims, under the heading "Abstract" or "Abstract of the Disclosure." The sheet or sheets presenting the abstract may not include other parts of the application or other material. The abstract must be as concise as the disclosure permits, preferably not exceeding 150 words in length. The purpose of the abstract is to enable the Office and the public generally to determine quickly from a cursory inspection the nature and gist of the technical disclosure.


關於美國專利說明書摘要撰寫規定,可參考MPEP 1826(https://www.uspto.gov/web/offices/pac/mpep/s1826.html

撰寫摘要的原則:

SUMMARY OF ABSTRACT REQUIREMENTS

Preferably 50-150 words. Should contain:(50-150字應指出發明領域、清楚指出發明解決的技術問題、解決方案的概要、用途、以小括號標註主要元件編號、必要時須放上化學式)

  • (A) Indication of field of invention.
  • (B) Clear indication of the technical problem.
  • (C) Summary of invention’s solution of the problem.
  • (D) Principal use or uses of the invention.
  • (E) Reference numbers of the main technical features placed between parentheses.
  • (F) Where applicable, chemical formula which best characterizes the invention.

Should not contain:(不應包括冗餘的語言、法律用語如said,means、優點與推測的應用,以及PCT rule 9規定禁止的事項,如下)

  • (A) Superfluous language.
  • (B) Legal phraseology such as “said” and “means.”
  • (C) Statements of alleged merit or speculative application.
  • (D) Prohibited items as defined in PCT Rule 9.

專利說明書不應記載以下事項:違反道德的內容或圖示、違反公眾秩序的內容或圖示、貶低申請人以外的其他人的產品或流程、貶低他人的優點與有效性(除非是跟自己前案比對)、其他無關或不必要的內容
(i)  expressions or drawings contrary to morality; 
(ii)  expressions or drawings contrary to public order; 
(iii)  statements disparaging the products or processes of any particular person other than the applicant, or the merits or validity of applications or patents of any such person (mere comparisons with the prior art shall not be considered disparaging per se); 
(iv)  any statement or other matter obviously irrelevant or unnecessary under the circumstances.


搜尋此類議題看到不錯的文章(僅列舉一些):

本部落格有關「摘要」的文章:
-在「有關摘要的撰寫規定 - 筆記&範例(https://enpan.blogspot.com/2020/04/blog-post.html」中提到:

"Abstract" or "Abstract of the Disclosure" as a heading.
「摘要」內容可視為說明書(specification)的一部分,因此,表示要符合112規定,也會被核駁並要求修正,也會影響專利是否核准。

「摘要」撰寫應簡明地描述技術特徵,應關於揭露書揭示的發明(不得有無關內容),應包括發明中新穎的部分,不能包括優點與推測的內容,也不應與現有技術比較(編按,十分重要的提醒)。

如果發明關於現有技術的改良,摘要應該要包括改良的內容。

(重要)如果適用,應該:(1)如果是機器或裝置,應包括其中組成與運作;(2)如果是物品,應包括其製作方法;(3)如果是化學成份,應包括其特性與用途;(4)如果是混合物,應包括其成份;(5)如果是流程,應包括其步驟。有關衍生的機構與設計細節不應包括在摘要中。


若發明涉及化學成份,應提出其通式。


-在「摘要的撰寫 - 避免言外之意(https://enpan.blogspot.com/2018/02/blog-post.html」中提到:

「摘要應以敘事方式撰寫,並限定在分開紙張的單一約50~150英文字的段落,應避免使用請求項的格式與法律措辭,如"means"(手段)與"said"(該),摘要描述的內容要實質幫助讀者決定是否有需要進一步查閱完整的專利文本。摘要用語應該清晰簡潔,不應重複如專利名稱的資訊,應避免使用暗示的用語,如"the disclosure concerns"、"the disclosure defined by this invention"與"the disclosure describes"等」。

這裡所謂「暗示(imply, implication)」應是指「言外之意」,或說「其他含意」。當摘要的用意是讓讀者可以快速得到專利的主要精神,就不應有「言外之意」。因此,MPEP提示哪些會有「言外之意」,列舉了常常會寫的「the disclosure concerns」、「the disclosure defined by this invention」與「the disclosure describes」等。

專利說明書中影響專利範圍解釋的內容 - Fenner Investments v. Cellco Partnership (Fed. Cir. 2015)enpan.blogspot.com/2024/12/fenner-investments-v-cellco-partnership.html
(摘要怎麼寫原則上是不會影響專利範圍)

Ron

2026年6月4日 星期四

程度用語不明確議題以及宣告 - Enzo Biochem, Inc., v. Applera Corp. (Fed. Cir. 2010)

查「Enzo Biochem, 599 F.3d at 1335, 94 USPQ2d at 1328」案例,因為兩造有兩件訴訟,有不同議題,本次討論為2010年 - Enzo Biochem, Inc., v. Applera Corp. (Fed. Cir. 2010)在MPEP 2173.05(b)是作為「解決不明確的"宣告"(declaration」說明的引用案例。

"During prosecution, an applicant may also overcome an indefiniteness rejection by providing evidence that the meaning of the term of degree can be ascertained by one of ordinary skill in the art when reading the disclosure. For example, in Enzo Biochem, the applicant submitted a declaration under 37 CFR 1.132 showing examples that met the claim limitation and examples that did not. Enzo Biochem, 599 F.3d at 1335, 94 USPQ2d at 1328 (noting that applicant overcame an indefiniteness rejection over “not interfering substantially” claim language by submitting a declaration under 37 CFR 1.132 listing eight specific linkage groups that applicant declared did not substantially interfere with hybridization or detection)."(在專利審查過程中,為了要克服不明確(程度用語)核駁意見,可以提出證據證明相關領域一般技術人員可以通過閱讀說明書而查明該用語。在Enzo Biochem案例中,申請人提交「符合專利範圍限制的範例和不符合專利範圍限制的範例」宣告,在不影響專利範圍解釋的情況下克服不明確核駁意見。

37 CFR 1.132 (提交證據以反駁核駁/rejections或基於缺陷的反對/objection意見的宣告)
Affidavits or declarations traversing rejections or objections.
When any claim of an application or a patent under reexamination is rejected or objected to, any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration under this section.

雙方另一爭議是:2017年均等論的議題 - Enzo Biochem v. Applera (Fed. Cir. 2017)均等論,永遠是個議題 - Enzo Biochem v. Applera (Fed. Cir. 2017)https://enpan.blogspot.com/2017/08/enzo-biochem-v-applera-fed-cir-2017.html)。


本篇討論2010年案:
原告/上訴人/專利權人:ENZO BIOCHEM, INC., ENZO LIFE SCIENCES, INC., and YALE UNIVERSITY
被告/被上訴人:APPLERA CORP. and TROPIX, INC.
系爭專利:US5,328,824、US5,449,767、US5,476,928、US5,082,830
判決日期:March 26, 2010

背景技術:
系爭專利關於標記與檢測核酸(如DNA和RNA)的技術,判決文前幾頁向我們說明相關背景技術,對於理解案例頗為受用。DNA與RNA的基本單元稱「核苷酸(nucleotide)」,每一個nucleotide由nitrogenous base、pentose sugar與phosphate group組成。DNA或RNA的兩股(strands)相互結合,或稱為「hybridize(雜交)」,形成雙股混合體(hybrid),此混合體通過互補鹼基之間的氫鍵連接在一起。

以上hybridize機制以DNA為例,一股上的adenine與另一股上的thymine相互結合;在RNA中,其中adenine結合到uracil;對於DNA與RNA,則是以cytosine結合guanine。所形成的雙股混合體稱「雜交/hybridization」,相反的程序則是將兩股分離,稱「denaturation」。

因為hybridization發生在可預測的互補股之間,因此可以用於檢測樣本中是否存在目標核酸(nucleic acid)。在此舉例,用"label/標記"結合到已知序列的核酸股,形成「檢測器」,使之雜交至互補序列,形成目標,一旦檢測器雜交於目標上,即產生可偵測的訊號,也就可以成為檢測核酸的依據

核酸的標記可以通過多種「化學物質」實現,如一種「放射性標記(radioactive labels)」,可以使用放射性檢測器檢測核酸,但是這有"可能有害、昂貴與不穩定"等缺點,系爭專利針對此放射性標記提出解決方案-使用一種化合物取代放射性標記,如:


根據判決文的解釋,在此化合物中,含氮鹼基「B」透過共價鍵直接或通過「linkage group」(圖中虛線)連接到化學物「A」。這個linkage group於系爭專利獨立請求項中是以"不實質干擾(not substantially interfere with)"功能性地寫在專利範圍中。所述化學物「A」就是系爭專利中用來檢測核酸的「label」。



地方法院階段:
專利權人Enzo於2004在地院對Applera提出侵權告訴,原本是提出6件專利,上訴後為4件專利。

在地方法院解釋專利範圍時,針對上述「linkage group」解釋,認為"不實質干擾"意思是不實質干擾化合物雜交於核酸的能力,也不實質干擾A可被檢測的能力

(...跳過一些技術討論...)

地院判決對'830侵權不成立。

針對'824、'767與'928,被告Applera提出系爭專利缺乏揭露內容(written description)、缺乏可據以實施(enablement)要件,以及不明確(indefinite)等不符35U.S.C.112專利無效的主張,另提出專利不具新穎性的主張,地院否決以上「缺乏揭露內容與無法據以實施」主張;但同意「不明確」以及「缺乏新穎性」的主張

(在此僅討論不明確議題)
地方法院認為系爭專利不明確的理由就是所述「不實質干擾(not interfering substantially)」用語不明確,因為說明書並未提出如何量測或是提出判斷門檻,因此判決以上三件系爭專利無效(不明確或是缺乏新穎性)。

學習一:針對相對用語,說明書應提出解釋:如量測方法、判斷門檻。

CAFC階段:
法院先建立法律基礎,包括針對112議題(針對'824、'767與'928)的立場,以及專利有效推定原則,如果要在法院證明專利無效,需要清楚而有說服力的證據(優勢證據)。

學習二法院說明缺乏新穎性與不明確兩個議題不能同時存在,理由是如果不明確就無法解釋專利範圍,也就不能判斷是否具有新穎性。

原告/專利權人Enzo主張專利說明書已經明確揭露所述「not substantially interfere with」- linkage group不實質干擾hybridization與detection,也就是說明書已經揭露量測的依據...。

CAFC法官同意Enzo的主張,認為是否「不明確」是基於相關領域技術人員是否可以理解來判斷的("Indefiniteness requires a determination whether those skilled in the art would understand what is claimed.")。解釋專利範圍應參考專利範圍用語、說明書與審查歷史,如果專利範圍涉及"純功能用語",相關判斷將強烈倚賴說明書與相關領域一般技術人員的知識。


學習三:是否明確不是單純以字面上(如本案例not substantially ...)來判斷,而是由相關領域技術人員是否可以理解來決定。

「不實質干擾」用語是用來描述「hybridization」與「detection」,法院對此提出見解。

CAFC修改地方法院針對三件系爭專利範圍的解釋,認為各案為獨立,專利範圍有差異,不應採用統一的解釋。雖同意地院對'824與'767中「hybridization」的解釋,但卻認為其中用語"substantially"模糊,並定義"substantially":可指近似或是描述程度(approximation或magnitude)。


在系爭專利中,所述"substantially"應指程度(language of magnitude),因為是用來描述干擾hybridization過程的程度。

於是法院鉅細靡遺地從說明書與審查歷史解釋所謂不實質干擾hybridization,特別地提到在專利審查過程中,Enzo針對不明確的核駁意見提出「宣告/declaration」,當時引用專家簽署的文件證明所述linkage group不實質干擾hybridization或是detection。


學習四:面對不明確質疑,可以提出專家證詞的宣告(declaration)。

法院又依據一些前例,認為即便申請專利範圍中沒有相關程度的判斷依據,但仍認為系爭專利範圍中涉及hybridization以及關聯的detection等描述為明確。

(在此忽略關於新穎性判斷的內容)

CAFC判決文:https://www.cafc.uscourts.gov/opinions-orders/09-1281.pdf

Ron

2026年5月22日 星期五

美國設計的圖式範例與規定 - 筆記

延續前一篇,仍是來看超有用美國設計專頁:https://www.uspto.gov/patents/basics/apply/design-patent,應該會分幾篇來筆記。

前一篇:設計新穎性優惠期隨筆 - 35 U.S.C. 102(https://enpan.blogspot.com/2026/05/35-usc-102.html)。

參考MPEP 1503 Elements of a Design Patent Application Filed Under 35 U.S.C. chapter 16https://www.uspto.gov/web/offices/pac/mpep/s1503.html)。

實務上,「美國設計申請案」規定是比其他各國更嚴格,要求比較多,從範例來看看美國設計專利的規定。

Straight-line surface shading(直線表面陰影)

相關規定段落:
37 CFR 1.152  Design drawings.
The design must be represented by a drawing that complies with the requirements of § 1.84 and must contain a sufficient number of views to constitute a complete disclosure of the appearance of the design. Appropriate and adequate surface shading should be used to show the character or contour of the surfaces represented. Solid black surface shading is not permitted except when used to represent the color black as well as color contrast. Broken lines may be used to show visible environmental structure, but may not be used to show hidden planes and surfaces that cannot be seen through opaque materials. Alternate positions of a design component, illustrated by full and broken lines in the same view are not permitted in a design drawing. Photographs and ink drawings are not permitted to be combined as formal drawings in one application. Photographs submitted in lieu of ink drawings in design patent applications must not disclose environmental structure but must be limited to the design claimed for the article.

II. SURFACE SHADING

While surface shading is not required under 37 CFR 1.152, it may be necessary in particular cases to shade the figures to show clearly the character and contour of all surfaces of any 3-dimensional aspects of the design. Surface shading is also necessary to distinguish between any open and solid areas of the article. However, surface shading should not be used on unclaimed subject matter, shown in broken lines, to avoid confusion as to the scope of the claim.

Lack of appropriate surface shading in the drawing as filed may render the design nonenabling and indefinite under 35 U.S.C. 112(a) and (b), (or for applications filed prior to September 16, 2012, pre-AIA 35 U.S.C. 112, first and second paragraphs). Additionally, if the surface shape is not evident from the disclosure as filed, the addition of surface shading after filing may comprise new matter. Solid black surface shading is not permitted except when used to represent the color black as well as color contrast. Oblique line shading must be used to show transparent, translucent and highly polished or reflective surfaces, such as a mirror. Contrast in materials may be shown by using line shading in one area and stippling in another. By using this technique, the claim will broadly cover contrasting surfaces unlimited by colors. The claim would not be limited to specific material either, as long as the appearance of the material does not patentably depart from the visual appearance illustrated in the drawing.


Stippling(點描)

相關規定段落:
Lack of appropriate surface shading in the drawing as filed may render the design nonenabling and indefinite under 35 U.S.C. 112(a) and (b), (or for applications filed prior to September 16, 2012, pre-AIA 35 U.S.C. 112, first and second paragraphs). Additionally, if the surface shape is not evident from the disclosure as filed, the addition of surface shading after filing may comprise new matter. Solid black surface shading is not permitted except when used to represent the color black as well as color contrast. Oblique line shading must be used to show transparent, translucent and highly polished or reflective surfaces, such as a mirror. Contrast in materials may be shown by using line shading in one area and stippling in another. By using this technique, the claim will broadly cover contrasting surfaces unlimited by colors. The claim would not be limited to specific material either, as long as the appearance of the material does not patentably depart from the visual appearance illustrated in the drawing.

Combination of straight-line shading and stippling(直線陰影與點描的組合)
(點描和直線陰影可以同時用在一個物體上,但不能在同一表面上同時使用)

相關規定段落:
III. BROKEN LINES

The two most common uses of broken lines are to disclose the environment related to the claimed design and to define the bounds of the claim. Structure that is not part of the claimed design, but is considered necessary to show the environment in which the design is associated, may be represented in the drawing by broken lines. This includes any portion of an article in which the design is embodied, or applied to, that is not considered part of the claimed design. See In re Zahn, 617 F.2d 261, 204 USPQ 988 (CCPA 1980). Unclaimed subject matter may be shown in broken lines for the purpose of illustrating the environment in which the article embodying the design is used. Unclaimed subject matter must be described as forming no part of the claimed design or of a specified embodiment thereof. A boundary line may be shown in broken lines if it is not intended to form part of the claimed design. Applicant may choose to define the bounds of a claimed design with broken lines when the boundary does not exist in reality in the article embodying the design. It would be understood that the claimed design extends to the boundary but does not include the boundary. When a boundary line is introduced via amendment or in a continuation application, the introduction of the boundary line must comply with the written description requirement of 35 U.S.C. 112(a) (or for applications filed prior to September 16, 2012, pre-AIA 35 U.S.C. 112, first paragraph). See In re Owens, 710 F.3d 1362, 1366-67, 106 USPQ2d 1248, 1251 (Fed. Cir. 2013). For example, unclaimed boundary lines should satisfy the written description requirement where they make explicit a boundary that already exists, but was unclaimed in the original disclosure. See Owens, 710 F.3d at 1368-69, 106 USPQ2d at 1252. Where no boundary line is shown in a design application as originally filed, but it is clear from the design specification that the boundary of the claimed design is a straight broken line connecting the ends of existing full lines defining the claimed design, applicant may amend the drawing(s) to add a straight broken line connecting the ends of existing full lines defining the claimed subject matter where such amendment complies with the written description requirement of 35 U.S.C. 112(a) (or for applications filed prior to September 16, 2012, pre-AIA 35 U.S.C. 112, first paragraph). Additionally, any broken line boundary other than a straight broken line may constitute new matter prohibited by 35 U.S.C. 132 and 37 CFR 1.121(f).


Transparent materials(透明材料)
(陰影斜線用於表示透明或半透明表面(拋光或反光表面),透明表面"後面可見的元素"應使用淺色實線表示,而不是虛線。)

相關規定段落:
Lack of appropriate surface shading in the drawing as filed may render the design nonenabling and indefinite under 35 U.S.C. 112(a) and (b), (or for applications filed prior to September 16, 2012, pre-AIA 35 U.S.C. 112, first and second paragraphs). Additionally, if the surface shape is not evident from the disclosure as filed, the addition of surface shading after filing may comprise new matter. Solid black surface shading is not permitted except when used to represent the color black as well as color contrast. Oblique line shading must be used to show transparent, translucent and highly polished or reflective surfaces, such as a mirror. Contrast in materials may be shown by using line shading in one area and stippling in another. By using this technique, the claim will broadly cover contrasting surfaces unlimited by colors. The claim would not be limited to specific material either, as long as the appearance of the material does not patentably depart from the visual appearance illustrated in the drawing.

Broken-line disclosure(虛線)
(虛線用於表示環境與邊界,屬於不主張權利的部份)

相關規定段落:
III. BROKEN LINES

The two most common uses of broken lines are to disclose the environment related to the claimed design and to define the bounds of the claim. Structure that is not part of the claimed design, but is considered necessary to show the environment in which the design is associated, may be represented in the drawing by broken lines. This includes any portion of an article in which the design is embodied, or applied to, that is not considered part of the claimed design. See In re Zahn, 617 F.2d 261, 204 USPQ 988 (CCPA 1980). Unclaimed subject matter may be shown in broken lines for the purpose of illustrating the environment in which the article embodying the design is used. Unclaimed subject matter must be described as forming no part of the claimed design or of a specified embodiment thereof. A boundary line may be shown in broken lines if it is not intended to form part of the claimed design. Applicant may choose to define the bounds of a claimed design with broken lines when the boundary does not exist in reality in the article embodying the design. It would be understood that the claimed design extends to the boundary but does not include the boundary. When a boundary line is introduced via amendment or in a continuation application, the introduction of the boundary line must comply with the written description requirement of 35 U.S.C. 112(a) (or for applications filed prior to September 16, 2012, pre-AIA 35 U.S.C. 112, first paragraph). See In re Owens, 710 F.3d 1362, 1366-67, 106 USPQ2d 1248, 1251 (Fed. Cir. 2013). For example, unclaimed boundary lines should satisfy the written description requirement where they make explicit a boundary that already exists, but was unclaimed in the original disclosure. See Owens, 710 F.3d at 1368-69, 106 USPQ2d at 1252. Where no boundary line is shown in a design application as originally filed, but it is clear from the design specification that the boundary of the claimed design is a straight broken line connecting the ends of existing full lines defining the claimed design, applicant may amend the drawing(s) to add a straight broken line connecting the ends of existing full lines defining the claimed subject matter where such amendment complies with the written description requirement of 35 U.S.C. 112(a) (or for applications filed prior to September 16, 2012, pre-AIA 35 U.S.C. 112, first paragraph). Additionally, any broken line boundary other than a straight broken line may constitute new matter prohibited by 35 U.S.C. 132 and 37 CFR 1.121(f).

However, broken lines are not permitted for the purpose of indicating that a portion of an article is of less importance in the design. See In re Blum, 374 F.2d 904, 153 USPQ 177 (CCPA 1967). broken lines may not be used to show hidden planes and surfaces which cannot be seen through opaque materials. The use of broken lines indicates that the environmental structure or the portion of the article depicted in broken lines forms no part of the design, and is not to indicate the relative importance of parts of a design.

In general, when broken lines are used, they should not intrude upon or cross the showing of the claimed design and should not be of heavier weight than the lines used in depicting the claimed design. When broken lines cross over the full line showing of the claimed design and are defined as showing environment, it is understood that the surface which lies beneath the broken lines is part of the claimed design. When the broken lines crossing over the design are defined as boundaries, it is understood that the area within the broken lines is not part of the claimed design. Therefore, when broken lines are used which cross over the full line showing of the design, it is critical that the description of the broken lines in the specification explicitly identifies their purpose so that the scope of the claim is clear. As it is possible that broken lines with different purposes may be included in a single application, the description must make a visual distinction between the two purposes; such as --The broken lines immediately adjacent the shaded areas represent the bounds of the claimed design while all other broken lines are directed to environment and are for illustrative purposes only; the broken lines form no part of the claimed design.-- Where a broken line showing of environmental structure must necessarily cross or intrude upon the representation of the claimed design and obscures a clear understanding of the design, such an illustration should be included as a separate figure in addition to the other figures which fully disclose the subject matter of the design. Further, surface shading should not be used on unclaimed subject matter shown in broken lines to avoid confusion as to the scope of the claim.

The following form paragraphs may be used, where appropriate, to notify applicant regarding the use of broken lines in the drawings.


Exploded view(爆炸圖)
(爆炸圖僅為設計的補充,必須使用"括號"來表示其中多個元件之間的關聯)


Alternate positions(多種位置)
(設計有不同的位置/樣態或是其中元件都應以分開視圖表示)

相關規定段落:
The design must be represented by a drawing that complies with the requirements of § 1.84 and must contain a sufficient number of views to constitute a complete disclosure of the appearance of the design. Appropriate and adequate surface shading should be used to show the character or contour of the surfaces represented. Solid black surface shading is not permitted except when used to represent the color black as well as color contrast. Broken lines may be used to show visible environmental structure, but may not be used to show hidden planes and surfaces that cannot be seen through opaque materials. Alternate positions of a design component, illustrated by full and broken lines in the same view are not permitted in a design drawing. Photographs and ink drawings are not permitted to be combined as formal drawings in one application. Photographs submitted in lieu of ink drawings in design patent applications must not disclose environmental structure but must be limited to the design claimed for the article.

Article shown broken away(物體被斷開)
(可利用斷開圖表示細節,但仍需有另一視圖顯示全貌;說明書應說明斷開部分顯示的物件不構成要保護的部分)



Cross-sectional view(剖面圖)
(剖面圖是為了減少視圖的用意,用以揭露內部結構。但是,僅用來展示內部結構或功能就不用提交剖面圖(畢竟設計一般是表示外部結構的特徵))


Multiple embodiments(多實施例)
(單一概念的多個實施例 - 外觀和形狀相似,可以在同一申請案提交)


Ron