先前專利造成的障礙讓後案不具非顯而易見性 - Acorda Therapeutics v. Roxane Labs (Fed. Cir. 2018)

（重要）本篇主題為「先前專利造成的障礙讓後案不具非顯而易見性」，但也可說是「前案造成後案無法主張非顯而易見性的輔助性因素」，主要概念是，即便系爭專利範圍所關聯的產品取得商業上的成功，甚至也解決了長久以來的需求，但因為專利範圍涵蓋了先前專利（已授權），法官認為，相關產品的成功是基於這個先前專利產生的障礙，而非系爭專利本身，使得系爭專利仍不具備非顯而易見性！（Acorda Therapeutics v. Roxane Labs (Fed. Cir. 2018)）

案件資訊：
原告/上訴人/專利權人：ACORDA THERAPEUTICS, INC.
原告/被上訴人：ALKERMES PHARMA IRELAND LIMITED
被告/交叉上訴人：ROXANE LABORATORIES, INC., MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA, INC.
系爭專利：US8,007,826; US8,663,685; US8,354,437; and US8,440,703
判決日：September 10, 2018

本案系爭專利涉及有助於改善多發性硬化症患者行走的藥，系爭專利並非4-AP本身（4-AP為習知技術），是描述一種包括4-AP的給藥方法，使用上則是取得更早有關治療「多發性硬化症」的4-AP藥品專利的專屬授權。如'826案的Claim 6，界定一種給藥方案（dosing regimen method），提供治療有效濃度的4-氨基吡啶，以改善有此需要的多發性硬化症的人的行走。

6. A dosing regimen method for providing a 4-aminopyridine (4-AP) at a therapeutically effective concentration in order to improve walking in a human with multiple sclerosis in need thereof, said method comprising:

initiating administration of 4-aminopyridine by orally administering to said human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a day without a prior period of 4-aminopyridine titration, and then,

maintaining administration of 4-aminopyridine by orally administering to said human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily; without a subsequent period of 4-aminopyridine titration,

whereby an in vivo C_maxSS:C_minSS ratio of 1.0 to 3.5 and a C_avSS of 15 ng/ml to 35 ng/ml are maintained in the human.

根據「給藥方法」的專利範圍，包括"通過口服給予所述人10毫克4-氨基吡啶的持續釋放組合物，每天兩次，持續一天，沒有先前的4-氨基吡啶滴定，開始給予4-氨基吡啶，然後，
通過每天兩次口服給予所述人10毫克4-氨基吡啶的緩釋組合物來維持4-氨基吡啶的給藥; 沒有隨後的4-氨基吡啶滴定時間，由此，在人體內維持體內C maxSS：CminSS比率為1.0至3.5，CavSS為15ng / ml至35ng / ml。"（Google翻譯）

重要的是，其中「4-氨基吡啶」為先前專利US5,540,938，本案系爭專利範圍與此先前專利息息相關的關係形成本案的障礙。（另一重要先前技術是：(Steven R. Schwid et al., Quantitative assessment of sustained-release 4-aminopyridine for symptomatic treatment of multiple sclerosis, 48 Neurology 817 (1997))）



在地方法院、CAFC審查這樣的專利範圍的「非顯而易見性」，需要理解專利範圍與先前技術的差別在哪裡？證據也在系爭專利說明書中，除了討論相關技術領域一般技術人員是否可以根據先前技術揭示內容輕易達成系爭專利範圍的發明外，本案因為涉及已公開藥品的使用，因此還討論「secondary indicia of non-obviousness」。

簡單來說，所述「非顯而易見性的輔助性指標（Secondary Indicia of Non-Obviousness）」考量的有：

- commercial success
- long-felt but unmet need
- made after others have failed to reach the same goal
- copied by others

然而，通過「非顯而易見性的輔助性指標」答辯的困難是，證明專利範圍界定的發明與這幾樣因素的「關聯性（nexus）」，如果專利範圍的技術與達到的成功、解決長久以來未解決的問題/需求、他人失敗自己卻成功，或是被他人仿冒的項目的關聯性不夠，恐怕是不容易證明發明的非顯而易見性。

回到本案，本案討論的系爭專利的「商業成功」與「解決長久以來的需求」可能是基於先前4-AP專利的障礙（範圍廣），使得系爭專利本身的「非顯而易見性」不夠強烈。


（跳過本案判決文中探討先前專利的研發與造成的影響的內容，然而這些"研究"是判決重要的依據，只是不容易簡短討論）

基於地院提出系爭專利不具非顯而易見性的結論，Acorda提出的上訴理由有三：
(1)地院錯誤地認為相關領域技術人員具有結合先前技術而達成系爭專利發明的成功的合理期待（reasonable expectation of success）；
(2)地院解釋專利範圍時，錯誤認為其中「4-AP serum levels of 15–35 ng/ml」為固有特徵；
(3)地院不當以先前專利造成的阻礙否定系爭專利的商業成功、他人失敗與解決長期未解決問題產生的非顯而易見性。



103(a)（pre-AIA）。


針對(1)：
CAFC認為Acorda答覆先前技術沒有結合動機而產生成功的合理期待，但被CAFC否決，反倒是Schwid已經描述各項藥品成份的資訊，具有測試為系爭專利的動機，可以成功形成系爭專利改善多發性硬化症的給藥內容。



針對(2)：
CAFC採用專家證詞，認為沒有證據顯示前案不能達到長期治療的效果，因此相關成份與效果為固有特徵。



針對(3)：
（重要）特別是針對上述專利權人的第(3)個上訴意見，法院認為本案「商業成功」的證據不足以證明專利範圍可以區隔先前技術產生的效果，主要理由是，即便是FDA准許上市的藥品，甚至快速得到市佔，但先前專利「阻礙」了相關市場競爭，使得CAFC判斷產品的商業成功僅是最小的價值證明（minimal probative value），而不足以判斷專利的非顯而易見性。



雖有前例提到專屬授權的先前專利不一定會折損商業成功的證據，但也是依程度而定，就本案而論，CAFC顯然認為系爭專利範圍發明雖是商業成功，但證據顯示其中流程主要內容都已經描述在先前技術中，使得僅須要一般實驗就可達成系爭專利。



結論是，經參考了系爭專利中有關專利權人得到專屬授權的Elan patent已經折損系爭專利商業上成功、他人失敗與解決長期未解決需求的證據，使得系爭專利並不具備非顯而易見性。

"We conclude that the district court did not err in viewing the Elan patent, among other evidence, as evidence that discounted the weight of Acorda’s evidence of commercial success, failure of others, and long-felt but unmet need so that “the evidence as a whole” in the case “prove[d] clearly and convincingly that the Acorda Patents are invalid due to obviousness.”"

本案判決：CAFC同意地院判決Acorda的系爭專利無效。

補充Newman法官的反對意見：

本案系爭專利的"顯而易見"結論並不是建立在明確而有說服力的證據上，先前技術並未建議（"suggest"）"選擇"系爭專利中的特定元件與其限制，沒有建議所述元件的"選擇"與組合對系爭專利中「緩解多發性硬化症的行走障礙」有成功的合理期待（"reasonable expectation of success"）。

"Obviousness of the Acorda Patents was not established by clear and convincing evidence. The prior art did not provide a suggestion to select the specific elements and limitations of the Acorda formulation, and did not suggest that such selection and combination would have a reasonable expectation of success in relieving the walking impairment of multiple sclerosis. From my colleagues’ contrary holding, I respectfully dissent."

判決文：
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2078.Opinion.9-10-2018.pdf（備份：https://app.box.com/s/6u5liwkbjjmuxjmwahwqtc2nqqqp7df4）

my two cents:
如果證明了專利與產品成功（或其他非顯而易見性的輔助性因素）的「關聯性」，如果產品的成功或其他因素是因為其中的特定「先前技術」，仍不足以證明專利的非顯而易見性，這樣顯然在使用「非顯而易見性的輔助性指標」的答辯中，還要特別區隔其中各項"先前"技術特徵，考慮各先前技術是否是造成產品成功的主因，並可能需要考量到專利權人取得的其他權利...，變得十分困擾。

本案例給我的教示是，撰寫專利範圍時，不要將「先前技術寫得很大（比例上）」！然而，這常常也是不容易的事。

參考資料：
https://patentlyo.com/patent/2018/09/therapeutics-invention-nonobviousness.html

本案將請求最高法院對「非顯而易見的客觀指標（objective indicia of nonobviousness）」的意見，參考文章：https://patentlyo.com/patent/2019/04/blocking-objective-nonobviousness.html

其他本部落格報導：
- 客觀的非顯而易見事實 - Novartis v. Torrent Pharma, Apotex, and Mylan (Fed. Cir. 2017)（https://enpan.blogspot.com/2017/04/novartis-v-torrent-pharma-apotex-and.html）
- 長期需求卻沒有成功解決的案例討論（https://enpan.blogspot.com/2016/06/blog-post_14.html）
- Apple v. Samsung的大戰中有涉及secondary consideration等進步性的輔助性答辯（http://enpan.blogspot.tw/2016/03/cafc.html）
- 輔助性因素可能不足以克服強烈的顯而易見性 - Intercontinental Great Brands v. Kellogg (Fed. Cir. 2017)（https://enpan.blogspot.com/2017/09/intercontinental-great-brands-v-kellogg.html）

Ron

日本特許法與意匠法的修法概要

（本篇摘記日本專利局公佈特許與意匠法修法，但尚未有確切的實施日期）

特許法等の一部を改正する法律案の概要（https://www.meti.go.jp/press/2018/03/20190301004/20190301004-1.pdf）


特許法（專利法）部分修訂：

• 技術專家參與侵權調查，將可進入疑似侵權人的工廠蒐證，並製作提交給法院的報告。
• 從侵權人獲利計算損害賠償時：侵權人的獲利中，其中認為是超出專利權人可製造的能力的部分，仍可納入損害賠償計算中。
• 根據授權金計算損害賠償時：應考量明確描述出在專利侵權前提下所協議的金額。
• 以上修法適用新型專利、意匠與商標。

日本設計（意匠）修法概要：

• 擴大保護對象，物品中未記錄、未表示的圖像或建築物外觀、內裝的設計將加入外觀設計的保護對象。
• 申請「關聯設計（関連意匠）」的時間從原本到「主設計（本意匠）」的註冊日（登録の公表日，約8個月）為止，延長至「主設計」申請日（出願日）後10年內，當然，僅同意與「主設計」相近的關聯設計。
• 「設計專利」期限比大多數國家都長，更從現行「註冊日起20年」延長至「申請日後25年」。（「登録日から20年」から「出願日から25年」に変更する）
• 同意「多個設計」在同一申請案提出申請。（可能如中國「同一產品」的多個外觀設計申請方案）
• 擴大間接侵權的涵蓋範圍：納入「以迴避為目的刻意將侵權品分成各構件進行製造與輸入」的行為。

其他：

• 允許公共利益團體（地方政府，大學等）取得以其著名的商標權。

（以上修法還沒有確切的實施日）

一些圖案：
特許侵害的特殊性：



擴充意匠保護對象：


擴充關聯意匠：


擴大意匠權利時間/擴充間接侵權解釋：


資料來源：
（2019年3月1日：https://www.meti.go.jp/press/2018/03/20190301004/20190301004.html）
特許法等の一部を改正する法律案の概要（https://www.meti.go.jp/press/2018/03/20190301004/20190301004-1.pdf）

部分資訊來源：
OGAMI PATENT（日本大上专利商标事务所）

其他很厲害的參考資料：
解析中國外觀設計專利之合案申請制度(上)（http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Design_Patent/publish-67.htm）
解析中國外觀設計專利之合案申請制度(下)（http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Design_Patent/publish-68.htm）

Ron

印尼專利申請程序筆記

印尼專利申請程序筆記。

印尼智慧財產局：http://www.dgip.go.id/。

就從WIPO資料（包括WIPO網站）來看印尼專利申請制度。

• 現行印尼專利法為2016年版本。
  
• 1979年加入WIPO（WIPO資料）。
• 印尼智慧財產局的組織如下，從組織來看，印尼智慧財產局轄下有(1)著作權、工業設計、積體電路佈局與營業秘密；(2)專利；(3)商標；(4)合作與促進；(5)資訊科技；(6)調查與研究等部門。
  
• 印尼專利申請案：「發明申請案」提出申請案後，3年內繳交審查費用，否則將撤銷申請案；「新型（simple patent）申請案」提出後，應於申請日當日或是申請後6個月內繳交審查費用（所以，印尼新型申請案為"審查制"）。
• 若要主張優先權，申請時應提交優先權文件。
• 若有主張優先權，印尼專利局可以要求申請人提交其他各國的審查意見，讓審查更有效率，如：他國專利獲准的資料、核駁決定、無效決定等。
• 申請人可以提供證明專利發明價值以及具備進步性的證據。
• 以上各種額外文件，可以另提解釋。
• 實際審查中，印尼專利局可以請求專家協助，或是使用適當的政府工具，也可以請求其他專利局的審查協助！（這部分為保密）
• 當接收到審查意見，申請人應於3個月內回應，可再延3個月。
• 若申請人並未回應審查報告，專利局會發出警示，之後還沒回應，該案將被撤銷（這個決定不能上訴）。
• 在作出最終審查意見之前，可以實施口審。
• 發明專利標的（patent）：product、apparatus、process/method，並不限定獨立與附屬請求項的項次。
• 新型專利標的（simple patent）：product、apparatus，且僅能提出一項獨立項，但附屬項次不拘。
• 印尼專利審查委員檢索工具：Espacenet、patentscope與其他線上工具，如US、EP、JPO、PCT。
• 申請程序如下，大致程序為：提出申請、最低要求審查，可以補件、取得申請日、形式審查，可以補件、18個月早期公開、請求實審（沒有即撤銷申請案）、核駁/核准，要求申請人回應、公告領證、駁回後10個月內可提訴願、上訴法院（commercial court）、最高法院（supreme court）。
  

補充印尼的simple patent：https://ambadar.co.id/knowledge-base/patent-and-simple-patent-in-indonesia/

印尼的Simple Patent對照一般知道的新型專利，專利期限為10年，專利標的限定在產品或裝置，並且，產品或裝置的形狀、配置、構造與元件應為新穎與具備實用性（少量實審），即可取得simple patent，Simple patent不適用強制授權。


本部落格有關印尼的報導：
印尼專利 - 用專利學地理（https://enpan.blogspot.com/2015/07/blog-post_16.html）
東協國家的設計專利（https://enpan.blogspot.com/2014/07/blog-post_24.html）
東協專利佈局 - iam觀點（https://enpan.blogspot.com/2017/11/iam.html）

WIPO資料：
https://www.wipo.int/edocs/mdocs/aspac/en/wipo_ip_kul_11/wipo_ip_kul_11_ref_t6.pdf

Ron

「不公開請求」案例分享

本篇為「不公開請求（Request Not to Publish）」的案例分享，不過，副標可以為：來不及主張優先權，但至少不要影響後案專利性。涉及「請求不公開」的討論。

範例：
美國申請案13/545,206，後來獲准US8693768。另一對照案為：WO2015126361。

WO2015126361資訊：
國際申請日（無優先權日）：02.18.2014
公開號：WO/2015/126361
國際申請號：PCT/US2014/016880

公開日：08.27.2015
申請人：ALINIC FAMILY PARTNERSHIP, LP
發明人：LAFORGIA, Lisa

13/545,206(US8693768 B1)資訊：
申請日（第一申請國）：07.10.2012
公告日：04.08.2014
專利獲准時擁有人：ALINIC FAMILY PARTNERSHIP, LP, NEW YORK

目前被授權人：Perfect Corp

發明人：LAFORGIA, Lisa

上述兩件案子有一致的揭露內容，從兩案的資訊來看，其實應該是同一個家族的專利申請案。

從申請日來看，WO2015126361的申請日已經超過美案'768申請日一年，無法主張優先權。猜測是"申請PCT時發現來不及主張優先權"，這種情況的風險是，從此PCT案衍生的後續各國申請案都可能會有專利性的問題，會被這個美案阻礙而無法獲准專利。

不過，當中有些蹊蹺。

從前案'768申請日來看，為07.10.2012，但到公告日（04.08.2014）之前卻沒有「早期公開日」，根據18個月早期公開的規則，'768應該在2014年1月左右會有公開的資訊，應該會阻礙後案WO2015126361取得專利的機會。

先看WO2015126361的檢索報告（International Search Report），並沒有'768的蹤影：


從美國專利局PAIR來查為何沒有提供公開，而延遲三個月公告獲准專利？

根據13/545,206的PAIR資訊，此案並沒有遭遇核駁意見，並已經在其申請日後18月之前獲准專利（12-02-2013），之後在02-20-2014提出「Rescind Nonpublication Request for Pre Grant Pub（撤銷不公開請求）」，之後USPTO在03-06-2014發出「Notice of New or Revised Publication Date（修改公開/公告日通知）」。



事實上，本案申請時（07-10-2012）在「Application Data Sheet」中提出「Request Not to Publish」（不公開請求），使得本案可以在獲准不公開，或是不實施早期公開。


Rescind Nonpublication Request for Pre Grant Pub
請求撤銷之前不公開請求。其中要求申請人在日後有國外申請案時，應通知USPTO，且應在國外申請案後45天內通知。如果沒有及時通知，本申請案將被拋棄。


Notice of New or Revised Publication Date（撤銷不公開請求，修正後公開日為06/12/2014）


根據以上資料，較早申請案在美國提出申請，並請求「不公開」，理由是不會在他國提出申請，之後在核准後又「撤銷不公開的請求」，且不久之後，申請人提出PCT申請案。...這可能是一種「挽救」，也是一種「申請策略」。

[法條]
本案申請時提出延遲公開的請求為依據「35 U.S.C. §122 (b)(2)(B)(i)」

If an applicant makes a request upon filing, certifying that the invention disclosed in the application has not and will not be the subject of an application filed in another country, or under a multilateral international agreement, that requires publication of applications 18 months after filing, the application shall not be published as provided in paragraph (1).

如果提出申請案，確認其中發明不會申請其他國家，或是提出任何多語國際協議下的申請案，可以提出不要早期18個月公開的請求。

35 U.S.C. §122 (b)(2)(B)(iii)

An applicant who has made a request under clause (i) but who subsequently files, in a foreign country or under a multilateral international agreement specified in clause (i), an application directed to the invention disclosed in the application filed in the Patent and Trademark Office, shall notify the Director of such filing not later than 45 days after the date of the filing of such foreign or international application. A failure of the applicant to provide such notice within the prescribed period shall result in the application being regarded as abandoned.

提出不公開請求的申請人，如果日後要提出國外申請案，應在申請日後45天內通知USPTO，如果沒有通知，本申請案將被視為拋棄。

35 U.S.C. 122 CONFIDENTIAL STATUS OF APPLICATIONS; PUBLICATION OF PATENT APPLICATIONS.

(b) PUBLICATION.—

• (1) IN GENERAL.—
  • (A) Subject to paragraph (2), each application for a patent shall be published, in accordance with procedures determined by the Director, promptly after the expiration of a period of 18 months from the earliest filing date for which a benefit is sought under this title. At the request of the applicant, an application may be published earlier than the end of such 18-month period.
  • (B) No information concerning published patent applications shall be made available to the public except as the Director determines.
  • (C) Notwithstanding any other provision of law, a determination by the Director to release or not to release information concerning a published patent application shall be final and nonreviewable.
• (2) EXCEPTIONS.—
  • (A) An application shall not be published if that application is—
    • (i) no longer pending;
    • (ii) subject to a secrecy order under section 181 ;
    • (iii) a provisional application filed under section 111(b); or
    • (iv) an application for a design patent filed under chapter 16.
  • (B)
    • (i) If an applicant makes a request upon filing, certifying that the invention disclosed in the application has not and will not be the subject of an application filed in another country, or under a multilateral international agreement, that requires publication of applications 18 months after filing, the application shall not be published as provided in paragraph (1).
    • (ii) An applicant may rescind a request made under clause (i) at any time.
    • (iii) An applicant who has made a request under clause (i) but who subsequently files, in a foreign country or under a multilateral international agreement specified in clause (i), an application directed to the invention disclosed in the application filed in the Patent and Trademark Office, shall notify the Director of such filing not later than 45 days after the date of the filing of such foreign or international application. A failure of the applicant to provide such notice within the prescribed period shall result in the application being regarded as abandoned.
    • (iv) If an applicant rescinds a request made under clause (i) or notifies the Director that an application was filed in a foreign country or under a multilateral international agreement specified in clause (i), the application shall be published in accordance with the provisions of paragraph (1) on or as soon as is practical after the date that is specified in clause (i).
    • (v) If an applicant has filed applications in one or more foreign countries, directly or through a multilateral international agreement, and such foreign filed applications corresponding to an application filed in the Patent and Trademark Office or the description of the invention in such foreign filed applications is less extensive than the application or description of the invention in the application filed in the Patent and Trademark Office, the applicant may submit a redacted copy of the application filed in the Patent and Trademark Office eliminating any part or description of the invention in such application that is not also contained in any of the corresponding applications filed in a foreign country. The Director may only publish the redacted copy of the application unless the redacted copy of the application is not received within 16 months after the earliest effective filing date for which a benefit is sought under this title. The provisions of section 154(d) shall not apply to a claim if the description of the invention published in the redacted application filed under this clause with respect to the claim does not enable a person skilled in the art to make and use the subject matter of the claim.

my two cents:
本案申請人在專利申請時提出「不早期公開請求」，理由是不會在別國或是PCT提出申請，但是...似乎在獲准專利時，決定要申請PCT案，即要求撤銷延遲公開/公告的請求，修改了公開/公告日。（編按，雖然看似合法，申請人在獲准前確實沒有申請他國專利，但在獲准後改變心意，但是也失去了主張優先權的權利，不過，之後仍提出PCT案，這似乎有點怪怪的）

確實會發生「來不及主張優先權」的情況，甚至可能會在前案申請日後18月後才想到佈局其他國家的，這時一般的反應是「將後申請案改一改」，避免被自己的前案打到（美國不適用），這時，本篇請求「Rescind Nonpublication Request for Pre Grant」的作法雖不意外，仍可以提供有此困擾的申請人參考。

感謝同事Liu提供案例。
Ron

新加坡專利實務筆記

新加坡專利申請筆記（https://enpan.blogspot.com/2014/02/blog-post_13.html）

此篇描述大致的新加坡發明專利申請程序：

Step 1: Application（申請）
Step 2: Preliminary Examination（初步審查、形式審查）
Step 3: Publication（公開）
Step 4: Search and examination（檢索與審查）

Step 5: Grant（核准）

進一步地： (1)申請：申請費與專利說明書（摘要、背景技術、實施方式、至少一項權利範圍與圖式）。權利範圍兩段式寫法。
(2)初步審查（preliminary examination）（形式審查）。
(3)申請日（或優先權日）後13個月內提出檢索要求（request for search report）。
(4)檢索與審查意見提出後2個月內繳費以提出補充檢索報告（supplementary search report）的要求。
(5)申請案型式：
(a)全本地方案（請求檢索而後審查程序（search-then-examination），或是組合檢索與審查的程序（search-and-examination））
(b)全國外方案（申請人提供對應本地申請案的國際申請案檢索與審查報告）
(c)組合式方案（申請人提出根據對應本地申請案的國際申請案檢索報告的審查請求）

實務筆記：

基於以上申請概要，方案之一是，申請人會在實際審查之前接獲檢索報告（Search Report），並會附帶一初步意見（Written Opinion）。

這時，申請人可以選擇是否要回應此檢索報告，這並非強制回應，如果這次不回應，相同的審查意見會在下次正式審查意見（Examination Report）重發一次。

提出發明申請後，新加坡智慧局發出檢索報告以及意見（Written Opinion）：

初步意見會論述申請案發明是否具備產業利用性（industrial applicability，專利法第16條）、新穎性（Novelty，專利法第14條）與進步性（Inventive Step，專利法第15條）：


依照申請案在國外的檢索、審查意見、費用等考量，新加坡專利局提出以下四種檢索與審查方案（https://www.ipos.gov.sg/protecting-your-ideas/patent/application-process/domestic-route）：


這四種方案可以依照實際需求選擇，主要是「時間」因素，而且各有優缺點：

方案一：13個月內提出檢索報告，36個月內審查，分兩階段，費用最貴，好處是可以根據審查報告決定是否要繼續審查。
方案二：36個月內檢索與審查，費用不高，好處是考量時間長與費用低。
方案三：36個月內審查，這適用有國外的檢索報告，費用低。
方案四：54個月補充審查，適用已經有國外檢索與審查結果的申請案，費用是0，應該是用在國外已經是核准的案子上。

新加坡專利法：
https://wipolex.wipo.int/en/text/484465

Examination Guidelines forPatent Applications at IPOS
https://www.ipos.gov.sg/docs/default-source/resources-library/patents/infopacks/examination-guidelines-for-patent-applications-at-ipos_2017-apr.pdf

資料來源：https://www.ipos.gov.sg/understanding-innovation-ip/patent

Ron

歐洲實際審查與退費筆記

筆記

審查與答辯，源自EPC ART.94(3)規定，當審查意見顯示專利申請案並未能核准專利，歐洲審查部門應要求申請人提出他的意見，並依照規定修正專利申請案。

EPC Rule 71規範實際審查的細節。

(1)歐洲審查單位應要求申請人在期限內修正任何缺陷與說明書、申請專利範圍與圖式。
(2)歐洲審查單位應提出合理的陳述，包括適當與全部的拒絕准予專利的理由。
(3)在歐洲審查單位核准專利前，應通知申請人。應要求申請人繳付核准、公告與申請專利範圍翻譯（另兩個官方語言，官方語言為英文、德文與法文）費用。
(4)如果歐洲專利申請案超過15項專利範圍，歐洲審查意見應要求申請人繳付第16項之後的請求項審查費用。
(5)當申請人繳付核准、公告與另兩個官方語言的費用，即視為同意相關內容與個人資料。
(6)若申請人請求合理的修正，歐洲審查部門同意修正後應提出新的審查意見。
(7)如果未繳付核准、公告與請求項費用，或是另兩個語言的翻譯沒有及時提交，申請案將被視為撤回。


Guidelines for Examination Part A, Chapter VI(2) 2.5 
退還審查費用條件（EPC Article 11）：

(i)審查費用（examination fee）全額退費：如果歐洲專利申請案撤銷、被拒絕或是在實際審查"開始前"撤回（if the European patent application is withdrawn, refused or deemed to be withdrawn before substantive examination has begun），可以全額退回審查費用；
(ii)審查費用退一半：如果歐洲專利申請案在實際審查已經"開始後"撤回，但在回應第一次審查意見的時間過期之前，或是在發出審查意見之前，可以退一半審查費用。

上述第(i)點適用於全部2016年7月1日當日或之後被撤回或拒絕的歐洲專利申請案。
上述第(ii)點適用在2016年11月1日當日或之後實際審查已經開始的全部歐洲專利申請案。

對於在2016年11月1日之前已經進入實際審查的歐洲申請案來說，無法退費。

p.s. 要通過詢問(EPO Form 2095)可知申請案是否已經開始實際審查。

[法條]
---------------------------------

Article 94 Examination of the European patent application

(1) The European Patent Office shall, in accordance with the Implementing Regulations, examine on request whether the European patent application and the invention to which it relates meet the requirements of this Convention. The request shall not be deemed to be filed until the examination fee has been paid.

(2) If no request for examination has been made in due time, the application shall be deemed to be withdrawn.

(3) If the examination reveals that the application or the invention to which it relates does not meet the requirements of this Convention, the Examining Division shall invite the applicant, as often as necessary, to file his observations and, subject to Article 123, paragraph 1, to amend the application.

(4) If the applicant fails to reply in due time to any communication from the Examining Division, the application shall be deemed to be withdrawn.


---------------------------------

Rule 71 Examination procedure

(1) In any communication under Article 94, paragraph 3, the Examining Division shall, where appropriate, invite the applicant to correct any deficiencies noted and to amend the description, claims and drawings within a period to be specified.

(2) Any communication under Article 94, paragraph 3, shall contain a reasoned statement covering, where appropriate, all the grounds against the grant of the European patent.

(3) Before the Examining Division decides to grant the European patent, it shall inform the applicant of the text in which it intends to grant it and of the related bibliographic data. In this communication the Examining Division shall invite the applicant to pay the fee for grant and publishing and to file a translation of the claims in the two official languages of the European Patent Office other than the language of the proceedings within four months.

(4) If the European patent application in the text intended for grant comprises more than fifteen claims, the Examining Division shall invite the applicant to pay claims fees in respect of the sixteenth and each subsequent claim within the period under paragraph 3 unless the said fees have already been paid under Rule 45 or Rule 162.

(5) If the applicant, within the period laid down in paragraph 3, pays the fees under paragraph 3 and, where applicable, paragraph 4 and files the translations under paragraph 3, he shall be deemed to have approved the text communicated to him under paragraph 3 and verified the bibliographic data.

(6) If the applicant, within the period under paragraph 3, requests reasoned amendments or corrections to the communicated text or keeps to the latest text submitted by him, the Examining Division shall issue a new communication under paragraph 3 if it gives its consent; otherwise it shall resume the examination proceedings.

(7) If the fee for grant and publishing or the claims fees are not paid in due time, or if the translations are not filed in due time, the European patent application shall be deemed to be withdrawn.


---------------------------------

Guidelines for Examination Part A, Chapter VI(2)

2.5 Refund of examination fee 

The examination fee is refunded:
(i) in full if the European patent application is withdrawn, refused or deemed to be withdrawn before substantive examination has begun (Art. 11(a) RFees); or
(ii) at a rate of 50% if the European patent application is withdrawn after substantive examination has begun and 
– before expiry of the time limit for replying to the first invitation under Art. 94(3) issued by the examining division proper or,
– if no such invitation has been issued, before the date of the communication under Rule 71(3) (Art. 11(b) RFees).

As concerns (i) above, this applies to all European patent applications which are withdrawn, refused or deemed to be withdrawn on or after 1 July 2016. As concerns (ii) above, this applies to all European patent applications for which substantive examination began on or after 1 November 2016 (see the Decision of the Administrative Council of 29 June 2016, OJ EPO 2016, A48). For all applications for which substantive examination began before that date, Art. 11 RFees as in force before 1 November 2016 continues to apply, which means that there will be no refund if the application is withdrawn, refused or deemed to be withdrawn at this stage of proceedings.

Communications under Art. 94(3) "issued by the examining division proper" (see also C‑III, 4) are all communications indicating that the application does not meet the requirements of the EPC and referring to deemed withdrawal under Art. 94(4) in case the deficiencies are not duly remedied. These include the following: invitations under Rule 137(4), minutes of consultations by phone or in person, accompanied by an invitation to remedy deficiencies, communications relating to the ‘completely contained' criterion pursuant to Rule 56(3), or summons to oral proceedings pursuant to Rule 115(1) to which a communication complying with the requirements of Art. 94(3) and Rule 71(1) is annexed. In contrast, communications addressing purely formal deficiencies and issued by formalities officers as part of the duties entrusted to them, even if issued on the basis of Art. 94(3), do not constitute communications under Art. 94(3) "issued by the examining division proper". Likewise, communications issued by the examining division itself on some other legal basis, such as Rule 164(2)(a), Rule 53(3) or Art. 124, have no bearing on the period for a withdrawal qualifying for the 50% refund (see the Notice from the EPO dated 30 June 2016, OJ EPO 2016, A49).


An applicant unsure whether substantive examination has begun and wanting to withdraw the application only if he will receive the 100% refund may make withdrawal contingent upon the refund ("conditional" withdrawal). The date of the start of examination (C‑IV, 7.1) is indicated by means of EPO Form 2095 in the public part of the dossier and is thus open to file inspection in the European Patent Register after publication of the patent application. If EPO Form 2095 is not on file, substantive examination is deemed to have started on the date on which the first communication from the examining division proper is issued (e.g. a communication under Art. 94(3), Rule 71(3) or any other legal basis as mentioned above). Before publication, the EPO will provide the applicant with the relevant information upon request, or this information can be accessed electronically via the My Files service. For more details see OJ EPO 2013, 153.

---------------------------------
EPC Article 11 Refund of examination fee

The examination fee provided for in Article 94, paragraph 1, of the Convention shall be refunded:
(a) in full if the European patent application is withdrawn, refused or deemed to be withdrawn before the substantive examination has begun;
(b) at a rate of 50% if the European patent application is withdrawn after substantive examination has begun and
- before expiry of the time limit for replying to the first invitation under Article 94, paragraph 3, of the Convention issued by the Examining Division proper or,
- if no such invitation has been issued by the Examining Division, before the date of the communication under Rule 71, paragraph 3, of the Convention.

感謝同事Jennifer提供資訊。

Ron

要有足夠的細節才有可能證明具備inventive concept - Secured Mail Solutions v. Universal Wilde (Fed. Cir. 2017)

Secured Mail Solutions, LLC v. Universal Wilde, Inc. (Fed. Cir. 2017)

案件資訊：
原告/上訴人/專利權人：SECURED MAIL SOLUTIONS LLC
被告/被上訴人：UNIVERSAL WILDE, INC.
系爭專利：
U.S. Patent Nos. 7,814,032, 7,818,268, and 8,073,787 are the “Intelligent Mail Barcode” patents. U.S. Patent Nos. 8,260,629 and 8,429,093 are the “QR Code” patents. U.S. Patent Nos. 8,910,860 and 9,105,002 are the “Personalized URL” patents.
判決日：October 16, 2017

本案緣起原告/專利權人Secured Mail Solutions LLC對地方法院同意以不符101規定議題的請願的決定（表示地院判決專利不具專利適格性）提出上訴。

系爭專利分別關於電子郵件認證、QR碼與個人化URL的技術，以'032為例，在認證程序中，通過電子郵件傳送認證資料，讓接收端通過信件內確認的動作達到身份認證的目的。（編按，這常見於利用電子郵件註冊特定網路服務的認證方式）

這些系爭專利各有專利範圍，如'032的Claim 1揭示使用單一條碼認證實體信件來信者的方法，'093與'002則是有關提供電子內容給郵件接收者的技術，前者以QR Code提供內容，後者則應用了個人化URL。

'032的Claim 1. A method for using a single barcode to verify the authenticity of and identify a sender of a physical mail object that is being sent from said sender to a recipient via a mail carrier, comprising:

a sender of a physical mail object generating a unique identifier, wherein said unique identifier comprises a numeric value, can be used by said sender to identify said physical mail object, and is distinguishable from a second unique identifier that can be used by said sender to identify a second physical mail object that is being sent from said sender to said recipient via said mail carrier;

encoding at least said unique identifier, sender data and recipient data into a single barcode, wherein said sender data identifies said sender of said physical mail object and said recipient data identifies a recipient of said physical mail object;

storing at least a portion of said encoded data in a database, said portion comprising at least said unique identifier, said sender data and said recipient data;

printing said single barcode on said physical mail object;

submitting said physical mail object to a postal carrier;

scanning by a scanner said single barcode to acquire said encoded data; and

comparing by a computer at least a portion of said encoded data to data stored in said database to verify the authenticity of said physical mail object, wherein said at least a portion of said encoded data comprises at least said unique identifier, said sender data and said recipient data and can be used by said postal carrier to identify said sender of said physical mail object.

'093的Claim 1. A method for providing electronic data to a recipient of a mail object, comprising:

Generating, by a processor, a barcode for a mail object, said barcode including at least a first set of mail data, said first set of mail data including data corresponding to said recipient of said mail object;

affixing said barcode to said mail object;

submitting said mail object to a mail carrier for delivery to said recipient of said mail object;

receiving said first set of mail data, including data corresponding to said recipient of said mail object, from a reception device of said recipient via a network;

providing said electronic data to said reception device via said network in response to receiving said first set of mail data, said electronic data including a content of said mail object;

wherein said reception device displays said electronic data to a recipient of said mail object by displaying said electronic data on a screen of said reception device.

'002的Claim 1. A method for providing electronic data to a recipient of a mail object, comprising:

using an output device to affix a single set of mail ID data to said mail object, said single set of mail ID data including at least recipient data, said recipient data comprising a personalized network address associated with said recipient of said mail object;

submitting said mail object to a mail carrier for delivery to said recipient of said mail object;

receiving said recipient data from a reception device of said recipient via a network; and

providing by at least one processor said electronic data to said reception device via said network in response to receiving said recipient data, said electronic data comprising a sender's web page that identifies said recipient of said mail object and includes data corresponding to a content of said mail object;

wherein said electronic data is configured to be displayed to said recipient via a web browser on a display of said reception device.

看來這些應用在信件的電腦技術都會面對35 U.S.C. § 101議題，自然也是應用TWO-STEP測試，系爭專利發明先被認定為抽象概念(step 2A)，因此考量專利範圍中是否具有足以轉換抽象概念為可專利的應用的進步特徵（inventive concept）(step 2B)。

發明是否符合35 U.S.C. § 101規定的可專利標的，邏輯大概是：
--------------------
(1)是否為新與有用的流程、機器、製程或物質成份？
(2)是否落於法定例外的標的：自然律、自然現象與抽象概念？
(3)依據Alice判例，採用two-step檢測。
發明是否涉及法定例外？
如果不是，就通過two-step檢測。
如果是，進一步判斷專利範圍是否包括足以將不可專利的發明轉換為可專利應用的進步特徵（inventive concept）？（"whether the claims contain an “inventive concept” sufficient to “transform the nature of the claim into a patent-eligible application.”"）

補充：USPTO於年初新版指導方針將step 2A分為兩個步驟：
(1) 是否申請專利範圍界定的發明引述法定例外？其中，抽象概念可以分為：數學概念（mathematical concepts）、一些組織人類行為的方法（certain methods of organizing human activity）以及心智活動（mental processes）等。

(2) 如果法定例外的事項可以整合到實際的應用（integrated into a practical application）上，引述了法定例外的相關申請專利範圍不算涉及（not directed to）法定例外。

- USPTO的2019開年禮之一 - 適格性指導方針（https://enpan.blogspot.com/2019/01/uspto2019.html）
--------------------

Alice Step One

根據地方法院對本案的意見是，全部系爭專利都是有關資訊標記的技術，涉及抽象概念。在專利權人Secured Mail上訴意見中，搬出Enfish案例，認為系爭專利是改善電腦技術的發明，且當年CAFC在Enfish的意見中還認為地方法院對於抽象概念的評斷標準太高。

不過，本案中，CAFC認為地院判決系爭專利為抽象概念，為101規定的法定例外，這是合理普遍的標準（a reasonably high level of generality）。並且，法院也澄清，Enfish案涉及電腦本身技術的改善（有關電腦記憶體中資料管理），卻不是利用電腦技術實現其他經濟活動或是如本案資訊標識的技術類型。

- 參考報導：改善電腦技術的軟體方法具有可專利性？ - Enfish LLC v Microsoft (Fed. Cir. 2016) （http://enpan.blogspot.tw/2016/05/enfish-llc-v-microsoft-fed-cir-2016.html）

Alice Step Two

若專利無疑地涉及抽象概念，即討論下一步，判斷專利是否轉換抽象概念為可專利應用。"In step two, we consider the elements of the claims to determine whether they transform the nature of the claim into a patent-eligible application of the abstract idea."

- 參考報導：應用習知裝置執行原本的工作不會轉換抽象為可專利的發明 - Content Extraction v. Wells Fargo Bank (CAFC 2014)（https://enpan.blogspot.com/2017/05/contect-extraction-v-wells-fargo-bank.html）

十分明確地，這個判斷步驟是要找專利範圍中是否具備可以實質超越抽象概念本身的「inventive concept（進步特徵/進步概念）」？

- 參考報導：關於編解碼的可專利性 - Recognicorp v. Nintendo (Fed. Cir. 2017)（https://enpan.blogspot.com/2019/01/recognicorp-v-nintendo-fed-cir-2017.html）

（此案提到："地院認為專利範圍為演算法本身，或是明顯為一般解決方案的活動而已（pre-solution activity and post-solution activity），並沒有足以讓抽象概念轉換為可專利標的的進步特徵/發明概念（inventive concept）。但CAFC提醒：不是因為引述了數學方法就會直接判斷沒有inventive concept，這應該是step 2A的討論，本案是因為專利範圍中的數學方法僅是將資料轉換成另一形式的資料。"）

因此，議題成為在專利範圍中是否可以找到具備「inventive concept」的證據？

這裡很明確地說，僅引述一般電腦或是加入"apply it with a computer"語句，不能轉換抽象概念為可專利發明。


對於barcode專利：
根據專利權人Secured Mail的意見，也如法院知道的，系爭專利在寄件者端產生條碼並附加在信件上為系爭專利發明的核心，條碼中記載了識別符、寄件者資料、接收者資料以及傳遞方法等（可能形成inventive concept的條件），但法院認為，專利範圍的描述並沒有解釋如何產生這些資訊，甚至要傳遞這些資訊也不用轉成條碼，使得判斷從專利範圍無法得出哪些特徵為「inventive concept」（"The claim language does not provide any specific showing of what is inventive about the identifier or about the technology used to generate and process it."）。

對於QR Code與personalized URL專利：
因為涉及網路技術，Secured Mail引用案例DDR Holdings, LLC v. Hotels. com，認為，以特定方式自動從多個來源產生網頁，以解決網路技術的問題，為可專利標的！



- 參考報導：商業方法可專利性？電腦軟體專利的生機 - DDR Holdings v. Hotels.com (Fed. 2014)案例討論（https://enpan.blogspot.com/2014/12/ddr-holdings-v-hotelscom-fed-2014.html）

CAFC的回應是，系爭專利缺乏技術細節，找不到以特定方法解決特定問題的技術特徵，認為其中技術為已知與習知，並採用一般通訊技術，因此並未具備inventive concept。

CAFC結論：

"We see no inventive concept that transforms the nature of the claims into a patent-eligible application of the abstract idea."



CAFC判決文：http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1728.Opinion.10-12-2017.1.PDF（備份：https://app.box.com/s/w27nv8udachbk1667w63uynzdz44o7hr）

my two cents:
要克服那麼多的101爭議與阻礙，專利範圍（與說明書）的撰寫變得是最根本的問題，看來，避免發明僅是簡單利用電腦，專利範圍要有具備inventive concept的證據，要有特定可解決特定問題的方法的描述，就是專利範圍（與其說明書）要有足夠的細節，克服101問題的機會才會比較大！

本部落格算是盡量嚴密跟隨與101有關的議題，幾乎判決中提到的引用前例都可在本部落格中找到，然而101議題雖原則與邏輯不變，也可能常常是老梗常談，但隨時有新增變化（即便很微小），算是專利這個領域最有趣的議題之一：https://enpan.blogspot.com/search/label/101。

看過很多案例引用Enfish案，但要注意的是，這是適用「電腦本身技術的改善」，不適用「應用電腦實現的技術」。

註記：
這件事證明我的記憶力很淺，本案已經在今年2月分析與報導過，但現在（April 30, 2019）才發現，這個案例竟然研究兩次，還沒有意識到。

沒有足夠的細節證明具有inventive concept - Secured Mail Solutions v. Universal Wilde (Fed. Cir. 2017)（https://enpan.blogspot.com/2019/02/secured-mail-solutions-v-universal_11.html）

Ron