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

關於用詞"amount"與顯而易見性議題 - Otsuka Pharmaceutical Co. v. Lupin Ltd. (Fed. Cir. May 21, 2026)

Otsuka Pharmaceutical Co. v. Lupin Ltd. (Fed. Cir. May 21, 2026)

案件資訊：

原告/上訴人/專利權人：OTSUKA PHARMACEUTICAL CO., LTD.

被告/被上訴人：LUPIN LTD., LUPIN PHARMACEUTICALS, INC.

系爭專利：US8,273,735、US8,501,730

判決日期：May 21, 2026

本案源起，2021年Lupin製藥公司告知Otsuka其向FDA提出學名藥（ANDA）申請案 - JYNARQUE®，結果專利權人Otsuka製藥公司（大塚製藥）對Lupin公司提起專利侵權（學名藥No. 216063）告訴，結果地方法院判決侵權不成立，並且判定系爭專利'735因為顯而易見為無效。

系爭專利涉及一種高純度托伐普坦製作方法，通過減少合成過程中關鍵氫化試劑－硼氫化鈉的用量，以解決習知製程中有雜質的問題。所述「托伐普坦（tolvaptan）」用於治療常染色體顯性多囊性腎病變 (ADPKD) 的化合物（通過Google翻譯）。

在此列舉'730案Claim 1，此為product by process專利範圍，在其前言部分描述藥物成分，主體則是描述一個步驟 - 降低方程式(1)中的「苯並氮雜卓化合物」：

Claim 1: "in an amount of 0.25 to 1 mole per 1 mole of the compount(1)"。

系爭專利'735則是描述'730中的方法步驟，其中Claim 6 - 產生降低上述方程式(1)中的「苯並氮雜卓化合物」的藥品（方程式(10)）的方法。

Claim 6："in an amount of 0.25 to 1 mole per 1 mole of the compound(1)"

Lupin所提交的ANDA申請案包括製程（DMF No.036263），成分Otsuka相似，但是劑量與製程時間不同。

案件經地院審理判定Lupin製程與系爭專利不同，侵權不成立，並且地院還考量Lupin提出的先前技術後判定系爭專利'735為顯而易見。

對於「amount」的解釋：

Otsuka認為地方法院採用一種「practical completion/實際完成」專利範圍解釋方法解釋其中的"amount/量"，但卻使用另一不同且矛盾的「absolute completion/絕對完成」的解釋方法判定Lupin製程不侵權。

Otsuka的主張Lupin侵權，理由是因為在藥品製程中的反應在"混合物中加入1摩爾當量的氫化劑之前"已經實際完成（practically complete）。

在解釋專利範圍階段，各方爭論在專利範圍中的"amount/量"。被告Lupin的解釋是「製程中氫化劑相關的量就是加入反應室的總量」（"make the relevant amount of hydrogenating agent the total amount added into the reaction chamber"）。

原告Otsuka主張專利範圍中加入「hydrogenating agent」的量是指在其中減量反應（reduction reaction）達到「practical completion/實際完成」之前。（"the claim term referred to “the amount of hydrogenating agent added before the reduction reaction reaches ‘practical completion’ or is ‘complete in a practical sense"）

編按，看不懂沒關係，就是雙方在解釋專利範圍中化學方程式(1)的"hydrogenating agent"量是多少有歧異（"in an amount of 0.25 to 1 mole per 1 mole of the compound(1)"），是被告解釋的hydrogenating agent參與反應的總量，或是原告解釋在反應實際完成之後加入hydrogenating agent的量。

對於專利範圍中"amount"的解釋，Lupin是導向製程中反應"絕對完成（absolute completion）"的量；但是，地院同意原告Otsuka的解釋，就是製程中減量反應發生直到達到實際完成（practical completion）的量。

然而，即便地院同意原告Otsuka的解釋（hydrogenating agent的量指的是在完成實際減量之前的量），但卻認為Otsuka並未證明被告製程「前驅酮成分落於其原始量0.05%之前反應已經實際完成」為侵權；或是，即便Lupin的製程在前驅酮0.05%時反應達到實際完成，但原告並未證明其中成分未達特定水平。

因此，即便同意原告對於"amount"的解釋，地方法院仍判定侵權不成立。

原告Otsuka上訴CAFC。

CAFC階段：

關於專利範圍解釋，即參考上述地院的解釋。基於地院的解釋專利範圍，加上專家提出得實驗結果，CAFC同意地院判決，Otsuka並未證明在被告Lupin的製程中減量反應在加入特定量之前已經完成，也就是即便同意上述"實際完成"的解釋，但證據不足。

另一是顯而易見性的議題。

顯而易見性的判斷包括以下四點（這常見在Office Action中）：

(1) the scope and content of the prior art; 

(2) differences between the prior art and the claims at issue; 

(3) the level of ordinary skill in the pertinent art; and 

(4) secondary considerations such as commercial success, long felt but unsolved needs, and failure of others.

相關引證包括揭露製程的Kondo前案，以及專家證人參考Kondo認為，有動機通過修正Kondo而選擇如系爭專利中的減量步驟，也就是基於Kondo、相關背景知識，對於系爭專利'735有成功的合理期待，加上認為專利權人Otsuka提出的「Secondary considerations」（非顯而易見性輔助性判斷因素）並未克服強大的顯而易見的證據，判定'735為顯而易見，專利無效。

專利權人主張系爭專利中提出的高純度托伐普坦（tolvaptan）相對先前技術而言具備無法預期的效果，以及質疑相關領域一般技術人員並非有動機修改Kondo而達成系爭專利的技術，其中充滿後見之明。

對此，顯見專家證人的重要性，基於被告提出的專家證人通過實驗證明相關領域一般技術人員可以修改Kondo而實現系爭專利減量步驟，還包括降低成本、改善反應安全、簡化後續程序等。

關於所述「Secondary considerations」，專利權人提出的理由是系爭專利的高量率與高純度，經法院審理，認為系爭專利採用了Kondo兩倍hydrogenating agent的量，並無法證明系爭專利產生無法預期的功效。雖然CAFC也沒有同意所有地院對於「Secondary considerations」的看法，但認為，如果僅是很弱的「Secondary considerations」的論述，仍無法克服顯而易見性的初步印象。

因此，CAFC同意地方法院無效系爭專利'735的判決。

判決文：https://www.cafc.uscourts.gov/opinions-orders/24-2297.OPINION.5-21-2026_2697380.pdf（備份：https://app.box.com/s/0bswatbx6oyuigbehv3g58gox91e8ssj）

資訊參考：https://patentlyo.com/patent/2026/05/borrowing-from-the-board-district-court-obviousness-in-the-post-ipr-era.html

Ron

侵害商業機密的損害賠償計算方法 - Versata Software, LLC v. Ford Motor Co. (Fed. Cir. May 22, 2026)

 -  Versata Software, LLC v. Ford Motor Co. (Fed. Cir. May 22, 2026)

案件資訊：
原告/上訴人：VERSATA SOFTWARE, LLC, FKA TRILOGY SOFTWARE, INC., VERSATA DEVELOPMENT GROUP, INC., TRILOGY, LLC
被告/交叉上訴人：FORD MOTOR COMPANY
判決時間：May 22, 2026

本案源起2004年，Ford Motor Company雇用Versata軟體公司開發汽車設定電腦軟體 - ACM與MCA，雙方制定授權合約MSSA，還有額外支援服務。到了2014年合約到期也沒有續約，Ford則推出自己的軟體PDO（軟體開發時間與前述合約重疊）。

推出PDO後，Ford提起「不侵害Versata智慧財產權或是不侵害Versata商業機密」的確認之訴（declaratory judgment），Versata則提起反訴，宣稱Ford侵害其商業機密以及違約（其中侵害商業機密主張係基於Defend Trade Secrets Act (DTSA) and the Michigan Uniform Trade Secrets Act (MUTSA)）。

Versata主張Ford侵害的商業機密為三個類別的組合：

在地院審理前程序（pre-trial proceedings）排除Versata專家證詞，理由是認為專家不當採用計算損害賠償的模型 - 計算Ford的利潤（enrichment）而非不當得利（unjust enrichment），也就是計算損害賠償超過Ford不當得利，並且損害賠償的內容涵蓋了無關的數據，地院認為計算損害賠償僅能參照雙方授權歷史，也就是僅能限定在合理的使用費用（reasonable royalty model of damages），不能涵蓋到Ford使用其軟體產生的利潤。

Versata對於地院在審理前程序的判定提起反對意見，要求基於「Daubert Decision」修正損害賠償的報告，法院同意Versata修正損害賠償的計算，不過仍要求要符合上述合理使用費用的模型（reasonable-royalty model）。於是，Versata基於「Georgia-Pacific factors」提出三個合理使用費用模型，藉此反映回溯到2011雙方談判的商業機密授權費用。地院同意其中僅涉及雙方授權歷史的使用費用的損害賠償計算。

以上說明地院要求Versata計算損害賠償僅能限定在雙方授權合約下的商業機密使用費用，而不能納入Ford使用其商業機密的價值。

2022年，在地院審理中，陪審團除了不同意侵害MCA商業機密的賠償外，其餘判決2千多萬美元的侵害商業機密的損害賠償，以及8千多萬違反合約的賠償。

經Ford抗議後，地院取消侵害商業機密的損害賠償，理由是陪審團並不知道Ford開發自己軟體的時間；也將違反合約的賠償金降至3塊美金。

原告Versata等人對於地方法院針對侵害商業機密與違約損害賠償（damages for trade secret misappropriation and breach of contract）的判決提起上訴。

CAFC階段：

基於上述兩種計算違反/侵害商業機密的損害賠償的計算方法 - DTSA與MUTSA。

其中DTSA讓法院能(1)基於侵害商業機密的實際損失（actual loss）計算損害賠償，以及(2)計算因為侵害商業機密不當得利的損害賠償，但並非是基於實際損失；或者是，根據侵害商業機密中未經授權揭露或使用商業機密的行為計算合理的使用費（reasonable royalty）。

MUTSA所計算的損害賠償包括侵害商業機密造成的實際損失，加上非實際損失的不當得利；同樣地，亦可根據侵害商業機密中未經授權揭露或使用商業機密的行為計算合理的使用費。

上述兩個計算模型的共通點就是，都涵蓋尚未考量實際損失時因為侵害商業機密的不當得利（unjust enrichment）。（"Thus, the plain language of both the DTSA and the MUTSA allow for unjust enrichment caused by the misappropriation of the trade secret that is not accounted for when calculating damages for actual loss."）

CAFC法官依據前例，認為侵害商業機密的損害賠償應包括「實際損失」與未考量實際損失的額外「不當得利」。

可參考此段結論：

（CAFC判決花了不小篇幅論述否決地院判決的心證 ~ 在此忽略，否決的理由主要是因為地院錯誤地不讓Versata計算不當得利的損失。）

CAFC基於DTSA與MUTSA定義「侵害商業機密」：

(A)取得從他人以不當手段拿到的商業機密。
(B)未經權利人同意而揭露或使用商業機密。
(C)從有義務保密的環境中取得商業機密，或是從有商業機密使用限制的情況下取得商業機密。

CAFC判決Versata呈現足夠證據證明Ford侵害商業機密，而計算Versata的損害賠償應同時包括實際損失與不當得利。

my two cents:

以上為本人以有限的知識從判決了解的內容，建議仍需參考判決原文。

如果有公司委外開發軟體，因為公司之間彼此協作時應該都會接觸彼此的"商業機密"，特別是公司可能在接觸到委外開發軟體的商業機密的期間也開發自己的軟體，即可能有違反商業機密的問題；然而，反之也是，委外者會接觸其雇用公司的營業秘密，彼此可能需要合約解決這層面的問題。

CAFC判決文：https://www.cafc.uscourts.gov/opinions-orders/24-1140.OPINION.5-22-2026_2698249.pdf（備份：https://app.box.com/s/lcjwovouioth7p1lurgu6caggvu44kx2）

Ron

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 16（https://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

設計新穎性優惠期隨筆 - 35 U.S.C. 102

超有用內容：https://www.uspto.gov/patents/basics/apply/design-patent

發明與設計"本質上"的差異規定在MPEP 1502.01

差異包括：(A)專利期限不同（現行）：發明20年、設計15年；(B)設計專利沒有維護費用；(C)設計案僅能有一項專利範圍；(D)審查委員可酌情限制申請案中的多個發明，但設計案僅能一個設計；(E)國際發明申請案依照PCT規定，國際設計申請案則適用Hague協議；(F)發明案一般優先權期限為1年，設計案則是6個月；(G)發明申請案可以主張美國臨時申請案優先權，但設計案沒有；(H)發明與植物申請案有RCE程序，但設計案並沒有；(I)設計案有CPA審查程序（可比擬RCE）；(J)發明申請案有早期公開規定，設計申請案沒有。

摘錄MPEP關於"design"新穎性規定的段落（本篇以設計為主角，但規定都與utility申請案一致）：

MPEP 2152 Detailed Discussion of AIA 35 U.S.C. 102(a) and (b)（https://www.uspto.gov/web/offices/pac/mpep/s2152.html）

MPEP 2153 Prior Art Exceptions Under 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1)（https://www.uspto.gov/web/offices/pac/mpep/s2153.html）

審查＂設計申請案＂新穎性時，同樣地須以其優先權作為有效申請日；若有阻礙新穎性的前案時，將考慮新穎性例外條款，AIA 35 U.S.C. 102(b)(1)(A)排除條款限於排除創作人或其共同創作人或自創作人/共同創作人直接或間接取得的人在有效申請日前一年內＂已公開揭露/publicly disclosed＂的創作。（ps.可排除自己＂申請日前一年內＂的公開揭露）

MPEP 2153.01

AIA 35 U.S.C. 102(b)(1)(A) provides exceptions to the prior art provisions of AIA 35 U.S.C. 102(a)(1). These exceptions limit the use of an inventor's or at least one joint inventor’s own work as prior art, when the inventor's or at least one joint inventor’s own work has been publicly disclosed by the inventor, a joint inventor, or another who obtained the subject matter directly or indirectly from the inventor or joint inventor not more than one year before the effective filing date of the claimed invention. AIA 35 U.S.C. 102(b)(1)(A) provides that a disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) is not prior art if the disclosure was made: (1) One year or less before the effective filing date of the claimed invention; and (2) by the inventor or a joint inventor, or by another who obtained the subject matter directly or indirectly from the inventor or joint inventor. MPEP § 2153.01(a) discusses issues pertaining to inventor-originated disclosures within the grace period. MPEP § 2152.01 discusses the “effective filing date” of a claimed invention.

AIA 35 U.S.C. 102(b)(1)(B)排除條款用於排除＂設計被創作人、共同創作人或直接或間接取得的人公開揭露＂"之後"的揭露。條件是(1)有效申請日前一年內；(2)創作被創作人等"更早之前已公開揭露"。（ps.創作人自己的公開揭露可以排除其他人在後的揭露，這些揭露都應該在＂設計申請日前一年內＂）

ps.以下節錄內容的下半部就是討論"創作人之前的公開揭露"也應在創作"有效申請日"前一年內，才自己符合AIA 35 U.S.C. 102(b)(1)(A)的grace period。

MPEP 2153.02

AIA 35 U.S.C. 102(b)(1)(B) provides an additional exception to the prior art provision of AIA 35 U.S.C. 102(a)(1). AIA 35 U.S.C. 102(b)(1)(B) excepts as prior art a disclosure of subject matter that occurs after the subject matter had been publicly disclosed by the inventor, a joint inventor, or another who obtained the subject matter directly or indirectly from the inventor or joint inventor (i.e., an inventor-originated public disclosure). Specifically, AIA 35 U.S.C. 102(b)(1)(B) provides that a disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) (patent, printed publication, public use, sale, or other means of public availability) is excepted as prior art if: (1) the disclosure was made one year or less before the effective filing date of the claimed invention; and (2) the subject matter disclosed had been previously publicly disclosed by the inventor, a joint inventor, or another who obtained the subject matter directly or indirectly from the inventor or joint inventor. The previous inventor-originated public disclosure of the subject matter typically will be a disclosure within the one-year grace period (i.e., a grace period inventor-originated disclosure). However, if the previous inventor-originated public disclosure of the subject matter was made outside the grace period, that disclosure itself would qualify as prior art under AIA 35 U.S.C. 102(a)(1), and could not be excepted under AIA 35 U.S.C. 102(b)(1)(A). In other words, a previous inventor-originated public disclosure of the subject matter can be effective to establish that a grace period disclosure is excepted as prior art regardless of whether the previous inventor-originated disclosure was made within the grace period or not. MPEP § 2152.01 discusses the “effective filing date” of a claimed invention. MPEP § 2155.02 discusses the use of affidavits or declarations to show that the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor, and MPEP § 2155.03 discusses the use of affidavits or declarations to show that the disclosure was made, or that the subject matter had been previously publicly disclosed, by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.

申請時是否要聲明「新穎性優惠期」的相關資訊，答案是可以不用，但提出聲明可以加快審查（寫在cross-reference (37 CFR 1.78)）。

Applicants can include a statement regarding any grace period inventor-originated public disclosures in the specification upon filing. See 37 CFR 1.77(b)(6) and MPEP § 608.01(a). In order to be effective to show that a grace period inventor-originated public disclosure is not prior art under AIA 35 U.S.C. 102(a)(1) because the AIA 35 U.S.C. 102(b)(1)(A) exception applies, the statement must convey the same information as would be required in a declaration under 37 CFR 1.130(a). See MPEP §§ 717.01(a)(1) , 2155.01, and 2155.03. An applicant is not required to identify any grace period inventor-originated public disclosures or to use the format specified in 37 CFR 1.77, but identifying any such disclosures may expedite examination of the application and save applicants (and the Office) the costs related to an Office action and reply. If the patent application specification as filed contains a specific reference to a grace period inventor-originated public disclosure, and an oath or declaration under 37 CFR 1.63 from the inventor or the appropriate joint inventor(s) has been made of record, the Office will consider it apparent from the specification that the grace period public disclosure is attributable to the inventor or a joint inventor, provided there is a sufficient explanation of why the exception applies to a particular disclosure and there is no other evidence to the contrary. The applicant should also provide a copy of the grace period inventor-originated public disclosure (e.g., copy of a printed publication). The format specified in 37 CFR 1.77(b)(6) may not be the basis to add information about inventor-originated grace period public disclosures to the specification after the filing date of the application. Such an amendment may be considered new matter. Applicants should use 37 CFR 1.130(a) to submit such information after filing.

Ron

美國專利審查流程（筆記USPTO講義）

本篇材料源自：https://www.uspto.gov/sites/default/files/documents/patent_examination_process.pdf

這份材料可以成為初學者的教材，十分淺顯易懂，又專業。

一些截圖加上我的簡單註解。

釐清用語：

專利審查委員的責任：

簡化的審查流程：

Title 35 U.S.C.的意義：

Title 37 CFR的意義：

主要專利核駁的法律基礎：

解釋專利範圍：

MPEP 2103

"C. Review the Claims

The claims define the property rights provided by a patent, and thus require careful scrutiny. The goal of claim analysis is to identify the boundaries of the protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention. Examiners must first determine the scope of a claim by thoroughly analyzing the language of the claim before determining if the claim complies with each statutory requirement for patentability. See In re Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998) (“[T]he name of the game is the claim.”)."

102:新穎性明顯是事實議題，也就是技術比技術，有事實基礎，一頁就講完。

103:"非/顯而易見性"是基於事實的法律議題，問題比較複雜，要好幾頁來講。

我發現對於審查委員提出"發明通過修正先前技術可以輕易達成"的103核駁意見的答辯方向：

運用4步驟判斷發明顯而易見性的範例：

接獲After Final Rejection後的標準措施：

最後看到專利獲准後「領證前異議程序（Third party preissuance submissions under 35 U.S.C. 122(e)）」：

提交「領證前異議程序」的時間點：

時間點應在「發出核准通知以前」或是「專利申請案第一次公開後6個月後」或是「專利申請案接獲第一次審查意見之後」，以當中較早的為準。

可參考：

－領證前異議程序以及監視計畫（有關PREISSUANCE SUBMISSIONS）（https://enpan.blogspot.com/2015/08/preissuance-submissions.html）

－preissuance submissions筆記與案例（https://enpan.blogspot.com/2016/05/preissuance-submissions.html）

Ron