"花"公開使用（public use）的新穎性議題 - IN RE: WINGEN LLC (Fed. Cir. 2023)

案件資訊：

上訴人：IN RE: WINGEN LLC

系爭案：申請號15/229,819（為US9,313,959的再領證案）

判決日：February 2, 2023

案件緣起美國專利US9,313,959申請人提出再領證申請案（reissue application），內容可以參考母案US9,313,959，為一種「Calibrachoa（查出的中文：萬鈴花）」變種「Cherry Star」的植物專利：

Claim 1：

1. A Calibrachoa plant comprising at least one inflorescence with a radially symmetric pattern along the center of the fused petal margins, wherein said pattern extends from the center of the inflorescence and does not fade during the life of the inflorescence,

and wherein the Calibrachoa plant comprises a single half-dominant gene, as found in Calibrachoa variety ‘Cherry Star,’ representative seed having been deposited under ATCC Accession No. PTA-13363.

中文參考Google翻譯：

1."萬鈴花"，包括至少一個沿融合花瓣邊緣的中心具有徑向對稱圖案的花序，圖案從花序的中心延伸並且在花序的生命期間不褪色，其中，"萬鈴花"包含單個半顯性基因，此為"萬鈴花"變種“Cherry Star”（櫻桃星）中所發現的，代表性種子已經以ATCC（美國典型培養物保藏中心）保存號PTA-13363保存。

判決文中的彩圖：

從Google查到的"萬鈴花"，看來是沒有「沿融合花瓣邊緣的中心具有徑向對稱圖案(cherry star)的花序」的圖案：

ATCC：美國典型培養物保藏中心（American Type Culture Collection）為一全球生物資源中心，網站：https://www.atcc.org/。

系爭申請案專利範圍特徵在植物包括「single half-dominant gene」（這是母案獲准的關鍵），可以在花瓣上形成中心星形圖案，這個樣式並未在野生萬鈴花中發現。

本次系爭申請案（再領證案）在審查過程中並不順利（編按，這也是再領證案的風險），歷經四次核駁（2次RCE）意見，審查委員在最後一次審查意見發出系爭申請案缺乏內容、非法定重複專利、缺乏可實施性，以及較早公開使用等核駁理由，特別是面臨其他公開前案（Proven Winners North America LLC (“Proven Winners”)、Butler、Dole）的阻礙（102, 103），其中Proven Winners還是原母案'959的"原始"共同專利權人，現在'959專利權人則為本案上訴人WinGen。

系爭申請案經最終核駁後，申請人上訴PTAB，PTAB認為"Cherry Star"申請前已經公開（在Home Depot event），且其中講義沒有任何保密協定（confidentiality restrictions），同意USPTO審查意見，認為系爭申請案不具新穎性。

CAFC階段：

- public use -

其中爭議的是，申請案主張的發明在申請日前已經是「公開使用（public use）」，申請人WinGen主張PTAB認定所有發明特徵的"公開使用"有誤，主張參與之前公開活動（Home Depot event）的人不會知道系爭申請案是通過"single half-dominant gene"得出"Cherry Star"，不應以發明已經公開使用認定不具新穎性。

（重要）CAFC判定發明是否已經公開使用（public use），採用的判斷是：(1) 所述公開使用是可以被公眾取得；或是(2)公開使用的部分是已經商業開發。

CAFC特別指出，雖然公開使用議題的案例很多，但過去關於植物專利的「public use」僅一件案例 - Delano Farms Co. v. Cal. Table Grape Comm’n, 778 F.3d 1243 (Fed. Cir. 2015)，剛好過去曾經有報導：

- 植物專利的新穎性討論 - Delano Farms v. California Table (Fed. Cir. 2015)（https://enpan.blogspot.com/2015/01/delano-farms-v-california-table-fed-cir.html）

所述Delano案指出一種葡萄變種的非授權使用（unauthorized use），雖然這個公開是可以被公眾看到，但因為沒有標示，沒有證據表示有人可以認出這些葡萄品種，判定非申請前已公開使用。

編按，所以證明"public use"是有一定門檻，仍不如以各種公開文獻、專利作為前案證據的證據力。

如此，以相同標準看本次案例中"Cherry Star"品種的萬鈴花是否已經在上述「Home Depot event」公開？相關證人證詞表示當時已經向與會人員公開"Cherry Star"的照片，表示與會人員已經知悉這個品種。

特別的是，根據CAFC想法，本次"Cherry Star"顯然是純粹的"裝飾性"的外觀（"purely ornamental"），與Delano案中不容易以外觀分辨的葡萄品種不同，雖在別的領域有類似判例，但這個特別之處在植物專利爭議中沒有特定前例。

與"內在特性"不同的是，本案所謂"使用"，就是直指花的外觀，因此在「Home Depot event」的公開已經算是"public use"。

在PTAB的結論是，因為在「Home Depot event」已經公開"Cherry Star"，之餘特徵是一種外在形式，算是可公眾取得系爭申請案主張的發明，CAFC同意PTAB觀點，判定系爭申請案claims 1-4, 6-7, 11不具新穎性，也確認其他請求項不具非顯而易見性。

補充：

美國專利法第251條 - Reissue（https://enpan.blogspot.com/2008/12/251-reissue.html）

35 U.S. Code § 252 - Effect of reissue

- 當專利(母案)另外提出「再領證申請案」，再領證申請案一旦獲准，母案將被拋棄。

- 再領證專利不應影響原來(母案)專利權人在商業上（如製造、銷售等）的權益。

The surrender of the original patent shall take effect upon the issue of the reissued patent, and every reissued patent shall have the same effect and operation in law, on the trial of actions for causes thereafter arising, as if the same had been originally granted in such amended form, but in so far as the claims of the original and reissued patents are substantially identical, such surrender shall not affect any action then pending nor abate any cause of action then existing, and the reissued patent, to the extent that its claims are substantially identical with the original patent, shall constitute a continuation thereof and have effect continuously from the date of the original patent.

A reissued patent shall not abridge or affect the right of any person or that person’s successors in business who, prior to the grant of a reissue, made, purchased, offered to sell, or used within the United States, or imported into the United States, anything patented by the reissued patent, to continue the use of, to offer to sell, or to sell to others to be used, offered for sale, or sold, the specific thing so made, purchased, offered for sale, used, or imported unless the making, using, offering for sale, or selling of such thing infringes a valid claim of the reissued patent which was in the original patent. The court before which such matter is in question may provide for the continued manufacture, use, offer for sale, or sale of the thing made, purchased, offered for sale, used, or imported as specified, or for the manufacture, use, offer for sale, or sale in the United States of which substantial preparation was made before the grant of the reissue, and the court may also provide for the continued practice of any process patented by the reissue that is practiced, or for the practice of which substantial preparation was made, before the grant of the reissue, to the extent and under such terms as the court deems equitable for the protection of investments made or business commenced before the grant of the reissue.

判決文：http://cafc.uscourts.gov/opinions-orders/21-2322.OPINION.2-2-2023_2074337.pdf（備份：https://app.box.com/s/ivslgcg6zzdklka7hc1g7fnhf2xxdv4i）

資訊來源：https://patentlyo.com/patent/2023/02/how-does-flowers.html

Ron

發明專利中的彩色圖式

一般來說，專利示意圖用黑白圖式，但也可能在某些情況下需要提出具有色彩的圖面來說明發明內容，例如一些需要表示材料特色的影像、設計專利與植物專利（美國）等，說明書都會表示其中有彩色圖案。對發明、設計專利而言，其中若需要彩色圖式，除了要繳交額外費用外，還有提出petition說明使用彩色圖的必要性。

舉例來說：
植物PP31980



植物PP31,978



設計D891,705


設計D891,469


發明US8335998


petition and petition decision




發明US9103714




[以下節錄自USPTO給申請人的注意事項「General information concerning patents」（https://www.uspto.gov/patents-getting-started/general-information-concerning-patents），但其實這些是規定在37CFR1.84等篇章的內容]

關於圖式的標準，圖式有黑白與彩色圖，常用的是黑白圖，如果提出彩色圖，除了要繳交額外費用外，還要提出「petition from Applicant to accept Color Drawings or Color Photographs」，且彩色圖仍要求要有足夠的品質以至於重製為黑白時仍可看出其細節。



且應在（發明專利）說明書中的「brief description of drawings」中寫下「"the patent or application file contains at least one drawing executed in color.  Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee."」。如果申請時沒寫，即便提出petition也會被駁回，因此應在提出petition時隨附主動修正（preliminary amendments）的說明書。

Standards for Drawings

(1) Drawings. There are two acceptable categories for presenting drawings in utility and design patent applications:

(a) Black ink. Black and white drawings are normally required. India ink, or its equivalent that secures solid black lines, must be used for drawings, or

(b) Color. On rare occasions, color drawings may be necessary as the only practical medium by which to disclose the subject matter sought to be patented in a utility or design patent application or the subject matter of a statutory invention registration. The color drawings must be of sufficient quality such that all details in the drawings are reproducible in black and white in the printed patent. Color drawings are not permitted in international applications (see PCT Rule 11.13), or in an application, or copy thereof, submitted under the Office electronic filing system.

The Office will accept color drawings in utility or design patent applications and statutory invention registrations only after granting a petition filed under this paragraph explaining why the color drawings are necessary. Any such petition must include the following:

(i) The fee set forth in § 1.17(h);

(ii) Three sets of color drawings; and

(iii) An amendment to the specification to insert (unless the specification contains or has been previously amended to contain) the following language as the first paragraph of the brief description of the drawings:

The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

(2) Photographs

(a) Black and white. Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. For example, photographs or photomicrographs of electrophoresis gels, blots (e.g., immuno-logical, western, southern, and northern), autoradiographs, cell cultures (stained and unstained), histological tissue cross sections (stained and unstained), animals, plants, in vivo imaging, thin-layer chromatography plates, crystalline structures, and, in a design patent application, ornamental effects, are acceptable. If the subject matter of the application admits of illustration by a drawing, the examiner may require a drawing in place of the photograph. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent.

(b) Color photographs. Color photographs will be accepted in utility and design patent applications if the conditions for accepting color drawings and black and white photographs have been satisfied. See paragraphs (a)(2) and (b)(1) of this section.

其他參考報導：
- 美國「彩色或照片」的設計專利筆記（https://enpan.blogspot.com/2020/01/blog-post_10.html）
- 美國專利圖式規定 - MPEP 1825（https://enpan.blogspot.com/2019/05/mpep-1825.html）
- 從一個設計案核駁理由學習「線條與顏色」（https://enpan.blogspot.com/2013/09/blog-post_24.html）
- 美國設計申請案（https://enpan.blogspot.com/2010/04/blog-post.html）

Ron

生物產品本身的可專利性討論 - 歐洲訴願案例G0002/12 - T1242/06

本案例關於生物方法的可專利性，雖有法規的阻礙，但是解釋上仍有可專利的空間，申請人建議可朝向Product-by-Process的解釋，可有效規避法定不可專利的阻礙。

歐洲擴大訴願委員會案件資訊：
案件編號：G 0002/12
上訴編號：T 1242/06 – 3.3.04
系爭案申請號：00940724.8；公開號：1211926
系爭案申請人：以色列

案例涉及法條有點複雜，但與生物可專利性的規定在歐洲生物科技指導方針（Biotech Directive），其中，特別是Article 6，其中規定不予專利的生物技術，如人類複製程序、人類本體生殖遺傳、人類胚胎的商業用途、非醫療利益在人或動物身上修改基因一致性的技術。

涉及生物品種的EPC規定在EPC 53(b)：
動植物品種或生物方法不能取得歐洲專利，但是不適用微生物生產程序：(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;

系爭案涉及生物科技，關於一種含水量低的蕃茄的養殖與生產方法（Method for breeding tomatoes having reduced water content and product of the method），申請時請求項1如下：

1. A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of:
crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed;
collecting the first generation of hybrid seeds;
growing plants from the first generation of hybrid seeds;
pollinating the plants of the most recent hybrid generation;
collecting the seeds produced by the most recent hybrid generation;
growing plants from the seeds of the most recent hybrid generation;
allowing plants to remain on the vine past the point of normal ripening; and
screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin.

大概的步驟是：雜交後產生混種；收集第一代雜種（雜交種子），並從其中繁殖、授粉，再收集最新的雜種；再一次繁殖，讓植物保持在成熟時的藤蔓上；之後篩檢出延長保存水果與水果皮起縐中含水量低的蕃茄。


既然歐洲擴大訴願委員會（Enlarged Board of Appeal）的裁決形同法院意見，參考先前案例支持其論點為必要的動作，例如引用過去案例：G2/12, 2/13（另有參考T 83/05等案例），可參考部落格報導：http://enpan.blogspot.tw/2015/05/g-212g-213.html，其結論：

• 排除「植物產物的實質生物程序（essentially biological processes for the production of plants in Art. 53(b) EPC）」的可專利性並非影響植物或植物材料產品專利（product claim directed to plants or plant material）的可專利性；
• （重要）如果申請案在申請時僅提出方法申請專利範圍（植物生產的實質生物程序），並不會導致非植物品種的植物或植物材料不可專利；
• 授予產品專利，並無關於生產該產品的實質生物程序。

如此可知歐洲擴大訴願委員會在本案例的態度，本案例最終裁決如下：

1. 專利申請案請求項範圍為落於EPC 53(b)的動植物品種解釋範圍中（"essentially biological processes for the production of plants or animals"），也就是，如果是產品專利，不能排除其可專利性；
2. 不可專利的規定限於動植物生物方法；
3. 請求項以方法界定產品（product by process）不同於方法範圍，因此系爭案請求項範圍為一產品專利；
4. EPC 53(b)排除可專利性的方法並非是本次系爭案以方法界定產品的專利；
5. 專利申請人選擇產品請求項或以方法界定產品的請求項撰寫方式並非是一個「撰寫技巧」或是規避法律障礙，這是一個為了符合可專利性的合法的選擇，使得專利可以滿足可專利性的規定。

"(e) Therefore, the allowability of a patent claim directed to either a plant or plant material or to such a plant product defined by specific method features is governed by provisions of the EPC concerning product claims and product-by-process claims independent of the issue of the allowability of a patent claim directed to an essentially biological process for the production of plants. Thus, the choice of one or the other claim category is not a matter of some sort of "skilful claim drafting" or circumvention of legal hurdles but of the prerequisites for their patentability."

歐洲擴大訴願委員會裁決，系爭案並非落於EPC 53(b)不可專利的動植物品種生產方法，並未排除其可專利性，意思是，即便系爭案請求項界定一個生物方法，但在此討論下申請人主張的是其產品，為可核准專利。



涉及法條：
歐洲生物科技指導方針（Biotech Directive）為歐洲地區生物科技專利的保護法：




特別是Article 6，其中規定不予專利的生物技術，如人類複製程序、人類本體生殖遺傳、人類胚胎的商業用途、非醫療利益在人或動物身上修改基因一致性的技術。

（http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0044&from=EN）

my two cents:
裁決很長，一半以上是過去案例的解釋，以及是否適用本案狀況的討論，但隱含一種「專利範圍的撰寫技巧」，也就是規避落入EPC 53(b)不可專利的生物方法，最好的方式就是將專利範圍直指一個生物產品，如本案的含水量低的蕃茄，如此，即便用方法範圍界定該產品，仍可以produce-by-process的方式解釋專利範圍。

歐洲擴大訴願委員會G 0002/12裁決：https://app.box.com/s/ozvrowg906irlpjwhzqaj7lho34bht9i

Ron

植物專利的新穎性討論 - Delano Farms v. California Table (Fed. Cir. 2015)

很少討論美國植物發明，所以這件有點意義。而且這件有關「加州葡萄」。

美國植物專利規範於35U.S.C.161，MPEP1600系列。植物專利是涵蓋發明、"發現"以及無性生殖任何獨特、新的物種，包括新的、混種、變種等的育種，但排除塊莖繁殖或是在未耕種情況下找到的植物。

35 U.S.C. 161   Patents for plants.

Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor, subject to the conditions and requirements of this title.

...

MPEP1608  Examination

Plant applications are subject to the same examination process as any other national application. As such, the statutory provisions with regard to patentable subject matter, utility, novelty, obviousness, disclosure, and claim specificity requirements apply (35  U.S.C. 101, 102,103, and 112). The sole exception in terms of applicability of these statutory provisions is set forth in 35 U.S.C. 162.

The prior art considered by the examiner is developed by a search of appropriate subclasses of the United States patent classification system as well as patent and nonpatent literature data bases. Where appropriate, a report may be obtained from the Agricultural Research Service, Horticultural Research Branch, Department of Agriculture. See MPEP § 1609.

植物專利（plant patent）審查仍是如發明、設計一般，需要具有新穎性與進步性（102,103），要符合101, 102, 103, 112等一般專利規定。


Delano Farms v. California Table (Fed. Cir. 2015)案件討論：
這是一件植物專利無效之訴，在地院簡易判決中，原告為種植葡萄的農夫，對系爭植物專利提出專利無效訴訟，而無須繼續支付授權金。

提出專利無效的理由包括：專利為公知，宣稱在pre-AIA的新穎性（102(b)）規定中，系爭專利優先權日一年前就已經為公知技術。特別的是，系爭專利為美國農業部（USDA，United States Department of Agriculture）所有，再授權給加州葡萄委員會（California Table Grape Commission），在專利申請前一年相關物種已經被公開，而此公開行為是農業部員工私下交給一個農夫的資訊，不過，這位農夫卻去種植生產這個新品種葡萄，還將種苗又給了自己的親戚。

似乎，這些農夫也被告知不得公開，直到進入專利申請前一年內的時間才能商業公開（比如販售），但是這仍是鎖不住這些農夫的嘴...。

對於102(b)的解釋，CAFC法官是認為要達公眾可存取，或是有商業行為才算「公開使用」，法院曾在先前案例主張保持秘密的第三方使用並不會影響之後申請專利的專利性，但是本案涉及的公開事件並未有任何保密協定，但美國農業部也未授權他們去給第三方使用，但是他們都曉得應該要保密。

先前案例的意見表示：

系爭專利：
PP16,229
血色皇家（Scarlet Royal）葡萄：

請求項1：
1. A new and distinct variety of grapevine plant, ‘Scarlet Royal’, substantially as illustrated and described, characterized by its attractive dark red fruit color, oval fruit shape, and firm flesh texture with a neutral sweet flavor.

PP16,284
秋王（Autumn King）葡萄：

請求項1：
1. A new and distinct variety of grapevine plant, ‘Autumn King’, substantially as illustrated and described, characterized by its attractive pale green fruit color, cylindrical to ovoid fruit shape, and firm flesh texture with a neutral sweet flavor.

本案：

原告是生產葡萄的單位（三位），生產這些葡萄顯然是經過授權的，不過因為發現專利申請前已公開的事實，即提出專利無效告訴。其中，被告中除了加州葡萄委員會外，還有政府機關FDA，本想豁免這個爭議，但是被否決，因為有相關前案已經拋棄這類權利。

判決文對於新穎性的討論涉及是否是員工的公開行為、第三方被告知後的保密情況等都有討論，但都證明這些人都沒有符合102(b)的公開事由，都算是私下自己試作的行為，就是「公開事實」的認定都排除了被告知的幾方沒有讓不特定的第三方知悉的情況。相關判斷如下：

最後CAFC同意地方法院對專利有效的決定，主張要滿足102(b)不予專利的條件，應「能被公開存取（publicly accessible）」，而被守密的第三方使用並不能無效之後申請的專利。


這個結論應該讓那位洩密的員工鬆了一口氣，但是私相授受的問題可能還需要解決。


CAFC判決原文：
http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1030.Opinion.1-7-2015.1.PDF

Ron