潘榮恩專利部落格、專利實務、專利筆記與Linux
enpan's Patent & Linux practice
(http://enpan.blogspot.tw/, http://enpan.blogspot.com/)
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ronpan@gmail.com,
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2021年5月6日 星期四
沒有清楚而無可爭辯的理由就不會重審 - In re Modern Font Applications LLC (Fed. Cir. 2021)
2021年5月3日 星期一
實施例多仍可能未達可實施性的揭露要求 - Amgen Inc. v. Sanofi-Aventis (Fed. Cir. 2021)
本篇討論案件「Amgen Inc. v. Sanofi-Aventis (Fed. Cir. 2021)」涉及「功能手段用語專利範圍」的解釋與可實施性(enablement),特別的是功能手段用語的專利範圍,更是要求說明書有足夠支持可據以實施的內容,而不是多個實施例就可以滿足。本案為延續雙方曾於2017已經有在說明書揭露標準的爭議,可參考:說明書揭露標準的討論 - Amgen v. Sanofi (Fed. Cir. 2017)(https://enpan.blogspot.com/2017/11/amgen-v-sanofi-fed-cir-2017.html),前後訴訟都是涉及專利的有效性,顯得專利說明書、專利範圍的撰寫真是專利系統的最基礎、最重要的工作之一。CAFC於2017年判決發回重審的主要理由是地方法院錯誤排除專利權人針對專利可實施性的證據,這回,原告/專利權人捲土重來,面對相同的系爭專利,相關議題的證據,CAFC作出不同前次的判決。
案件資訊:
原告/上訴人:AMGEN INC., AMGEN MANUFACTURING, LIMITED, AMGEN USA, INC.
被告/被上訴人:SANOFI, AVENTISUB LLC, FKA AVENTIS PHARMACEUTICALS INC., REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S. LLC
系爭專利:US8,829,165、US8,859,741
判決日:February 11, 2021
系爭專利關於低密度脂蛋白(low-density lipoprotein (“LDL”))膽固醇的升高關於心臟疾病的技術,LDL受體(LDL receptor)從血液移除LDL膽固醇,藉此調節身體中低密度脂蛋白膽固醇的量,然而一種蛋白酶"PCSK9"會降解(degradation)LDL受體,本案的Amgen的專利'165與'741描述結合一種可以降解LDL受體的蛋白酶("PCSK9")的抗體,能藉由阻擋"PCSK9"以避免降解LDL受體。
系爭專利'165與'741有相同的說明書,其中舉出很多的抗體氨基酸序列,範圍包括:claims 19 and 29 of U.S. Patent 8,829,165 (the “’165 patent”) and claim 7 of U.S. Patent 8,859,741 (the “’741 patent”),這些系爭專利範圍也是早於2014年雙方的侵權訴訟,當時(第一回合),被告Sanofi提出專利無效(缺乏可實施性,"lack of enablement and written description")請願,陪審團判決專利有效,但案件經上訴後,CAFC駁回,並發回重審(可參考:(https://enpan.blogspot.com/2017/11/amgen-v-sanofi-fed-cir-2017.html)。
第二回合:地方法院陪審團再次否決被告提出系爭專利缺乏可實施性的主張,判決專利有效,被告Sanofi提起專利缺乏可實施性而無效的請願,這回地院同意專利無效請願,原告/專利權人Amgen提出上訴。
在此列舉'165圖20A與Claim 19:
1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
19. The isolated monoclonal antibody of claim 1 wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3.
claim 7 of U.S. Patent 8,859,741:
1. An isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
2. The isolated monoclonal antibody of claim 1, wherein the isolated monoclonal antibody is a neu-tralizing antibody.
7. The isolated monoclonal antibody of claim 2, wherein the epitope is a functional epitope.
本次案例涉及35 U.S.C. § 112(a)中可實施性的要求,post-AIA 102(a)(以下修改痕跡表示AIA前後修正):
(a) IN GENERAL.--The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention of carrying out his invention.
(重要)然而,要證明「專利不具可實施性」需要明確的證據,證明相關領域一般技術人員無法依照系爭專利說明書內容"在不用過度實驗下"而據以實施的證據,這裡考量案例In re Wands,判斷是否需要過度實驗的事實考量因素有:
(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
((1)實驗需要的數量;(2)說明書指出的方向的數量;(3)說明書是否有實施範例;(4)考量發明的本質;(5)先前技術狀況;(6)本領域技術人員的相對技能;(7)本領域r技術的可預測性或不可預測性;以及(8)專利範圍的廣度。)
"III. DETERMINING WHETHER THE FULL SCOPE OF A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION IS ENABLED
To satisfy the enablement requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without “undue experimentation.” See, e.g., In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Wands, 858 F.2d 731, 736-37, 8 USPQ2d 1400, 1402 (Fed. Cir. 1988). In In re Wands, the court set forth the following factors to consider when determining whether undue experimentation is needed: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. Wands, 858 F.2d at 737, 8 USPQ2d 1404. The undue experimentation determination is not a single factual determination; rather, it is a conclusion reached by weighing all the factual considerations. Id."
(重要)以上幾點考量形成專利說明書的撰寫基本門檻,亦根據2020年案例McRO v. Bandai指示,即便專利說明書並不需要描述如何製造與使用請求項界定發明的各種變化,但根據所主張專利範圍,必須揭示相關範圍的合理的可實施內容。("Although a specification does not need to “describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range.”")。
原告/專利權人Amgen上訴CAFC,要求法院撤銷地院判決系爭專利缺乏可實施性揭露內容的決定。Amgen提出專家證詞,以及說明書已經揭露多達26個範例,足以讓相關領域一般技術人員可據以實施。被告即依據上述In re Wands的幾個考量認為系爭專利範圍缺乏說明書支持的可實施性,使得相關抗體的產生沒有可預測性,需要過度實驗。
CAFC法官參考In re Wands的幾個考量,以及多個關於是否需要過度實驗(undue experimentation)的可實施性前例,作出的結論是,在以功能性描述的專利範圍中,特別是可預期性(predictability)與說明書提供的指導(guidance)較缺乏時,應考量製造與使用專利範圍發明所要求實驗的量,不僅是專利說明書中有限的實施例的數量。意思就是說,說明書實施例的數量不代表實驗專利範圍的量。
(重要)進行In re Wands因素分析時,具體識別出實施例與不能實施的實施例,專利範圍的廣度為具體的,而非抽象的可能性,應考量相關領域技術人員需要多少的實驗才能製造或使用專利範圍中所界定的產品或流程。
(重要)法院認為,要求請求項描述一定的結構特徵(編按,這裡"structure"並非是限定"機構的結構",應解釋到更廣的"結構",各領域都有相應的結構),也要求執行相關功能的技術效果,而所述「過度實驗」就從專利範圍的功能元件來看,也要求結構的描述。也就是說,以功能手段用語界定的專利範圍仍需要滿足可實施性的要求,但也限制了使用功能性用語的專利範圍的廣度。
如此,對於本案來說,系爭專利範圍定義了幾個成份,但不是結構特徵,而是功能性的限制,CAFC同意地方法院判決,系爭專利說明書並未符合在無須過度實驗下可實施系爭專利範圍的要求。
本案中,雖系爭專利說明書提供了一些指引,如實施例中的數據,但考量了相關技術領域中的「不可預測性」,說明書仍提供不足的指引使得相關領域一般技術人員可以實現請求項記載之發明。
my two cents:
從本案來看,給撰寫專利說明書的人一個挑戰,不是實施例多就是滿足「可實施性」,而且,會依照專利範圍要求的廣度要求揭露程度,如用功能手段用語寫的專利範圍,更需要足夠支持製造與使用相關技術的內容,不僅是實施例的數量而已。
判決文:http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf(備份:https://app.box.com/s/bp0f6qo9z2dv02msfjm764rpmgj10zbc)
資料參考:https://patentlyo.com/patent/2021/04/amgen-v-sanofi.html
Ron
2021年4月30日 星期五
112(f)解釋專利範圍脈絡 - 筆記
112(f)解釋專利範圍的脈絡:
1) 解釋專利範圍採用最廣而合理的解釋原則(broadest reasonable interpretation),解釋專利範圍時,相關領域一般技術人員(ordinary skill in the art)根據請求項文字表面意義,參考說明書內容,作出最廣而合理的解釋。而針對訴諸112(f)解釋的專利範圍而言,最廣而合理地解釋專利範圍中的元件時,將受到說明書描述的限制。
2) 解釋訴諸112(f)解釋的專利範圍時,採用三個判斷,可參考:是否訴諸112(f)的三個判斷 - MPEP 2181, section I(https://enpan.blogspot.com/2018/07/112f-mpep-2181-i.html):
(A) 當請求項中使用「means」或「step」或其他描述執行功能的用語(通用佔位符,generic placeholder),將訴諸112(f)解釋。
(B) 所述「means」或「step」或其他通用佔位符修改為功能用語,如configured to, so that這些描述,將訴諸112(f)解釋。
(C) 所述「means」或「step」或其他通用佔位符未以足夠的結構、材料或動作描述其功能,將訴諸112(f)解釋。
3) 使用所述「means」或「step」或其他通用佔位符時,將訴諸以112(f)解釋專利範圍,然而,若請求項中以足夠的結構、材料或動作描述所執行的功能時,就不用以112(f)解釋專利範圍。
4) 若請求項中未使用所述「means」或「step」或其他通用佔位符,專利範圍不會訴諸112(f)解釋,但是,當請求項中未以足夠的結構、材料或動作描述所執行的功能時,則仍會訴諸112(f)解釋。
5) 雖然專利請求項中未使用所述「means」或「step」用語,但其中採用了一些通用佔位符加上功能用語,且未記載足夠的結構、材料或結構,仍會訴諸112(f)解釋,也就是參考說明書中執行相關功能的結構特徵,將其中描述解釋專利範圍。
6) 根據上述第5)點,若申請人/發明人不想訴諸112(f)以說明書的描述限制專利範圍,可以採取的動作是:(1) 修改申請專利範圍,以迴避訴諸112(f)解釋,比如:加入執行其中功能足夠的結構特徵;或是(2) 表明請求項中已經有執行其功能足夠的結構特徵,以此迴避以112(f)解釋專利範圍。
Ron
專利適格性的答辯歷史筆記 - 評分一個帳戶
第二次OA的101核駁:前次修正併入的技術特徵,單獨或整體來看,並未建立有意義的技術限制使之超越法定不予專利理由。
第二次修正(Claim 16):
這次的答辯意見(針對101),Google表示修正專利範圍Claim 16,併入的特徵描述藉由判斷安全性相關行為而保護儲存帳戶數據避免未授權存取的系統,並列舉出所述安全性相關行為的幾個項目。據此,再引用註明案例DDR Holdings LLC v. Hotels.com, LP (Fed. Cir. 2014),主張如法院對此前案的判定中指出:如果並非單純描述通過網路驅使商業活動的效能,若提供的電腦技術可以克服電腦網路領域中的問題,為符合專利適格性的可專利的發明。
608.01(m) Form of Claims
The claim or claims must commence on a separate physical sheet or electronic page and should appear after the detailed description of the invention. Any sheet including a claim or portion of a claim may not contain any other parts of the application or other material. While there is no set statutory form for claims, the present Office practice is to insist that each claim must be the object of a sentence starting with "I (or we) claim," "The invention claimed is" (or the equivalent). If, at the time of allowance, the quoted terminology is not present, it is inserted by the Office of Data Management. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v.Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i).
There may be plural indentations to further segregate subcombinations or related steps. In general, the printed patent copies will follow the format used but printing difficulties or expense may prevent the duplication of unduly complex claim formats.
Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. The reference characters, however, should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim.
Many of the difficulties encountered in the prosecution of patent applications after final rejection may be alleviated if each applicant includes, at the time of filing or no later than the first reply, claims varying from the broadest to which he or she believes he or she is entitled to the most detailed that he or she is willing to accept.
Claims should preferably be arranged in order of scope so that the first claim presented is the least restrictive. All dependent claims should be grouped together with the claim or claims to which they refer to the extent practicable. Where separate species are claimed, the claims of like species should be grouped together where possible. Similarly, product and process claims should be separately grouped. Such arrangements are for the purpose of facilitating classification and examination.
When two claims in an application comply with the requirements of 35 U.S.C. 112(d) but are duplicates, or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other claim under 37 CFR 1.75 as being a substantial duplicate of the allowed claim. Note however, that court decisions have confirmed applicant’s right to restate (i.e., by plural claiming) the invention in a reasonable number of ways. Indeed, a mere difference in scope between claims has been held to be enough. Form paragraphs 7.05.05 and 7.05.06 may be used where duplicate claims are present in an application.
See MPEP § 608.01(n), subsection II, for rejections under 35 U.S.C. 112(d) of dependent claims that do not specify a further limitation of the subject matter claimed. See MPEP § 804 for double patenting rejections of claims in different applications that are not patentable over each other.
The form of claim required in 37 CFR 1.75(e) is particularly adapted for the description of improvement-type inventions. It is to be considered a combination claim. The preamble of this form of claim is considered to positively and clearly include all the elements or steps recited therein as a part of the claimed combination.
The following form paragraphs may be used to object to the form of the claims.
2021年4月28日 星期三
專利適格性涉及事實議題的討論 - WhitServe LLC v. Dropbox, Inc., 19-2334 (Fed. Cir. 2021)
參考案例「Berkheimer v. HP, Inc. (Fed. Cir. 2018)」(可參考:整體性地考量專利適格性,這是法律議題 - Berkheimer v. HP, Inc. (Fed. Cir. 2018)(https://enpan.blogspot.com/2018/04/berkheimer-v-hp-inc-fed-cir-2018.html))意旨,法院判定系爭專利'437不具專利適格性,理由是,參考系爭專利說明書等內部證據(事實證據),可以判定其中系統使用了備份記錄的基本商業概念,實現取得與儲存備份檔案的抽象概念的一般環境,專利範圍中的元件為已知、常規與習知(well-understood, routine and conventional)。
2021年4月27日 星期二
販售要約滿足專利申請前已販售證據(on-sale bar) - Caterpillar v. ITC & Wirtgen (Fed. Cir. 2020)
經調查相關文件,有收據、有報表顯示1999年已經販售系爭產品SF 102 C Bitelli,對於此證據,專利權人並未爭辯,但爭辯的是,這些銷售記錄並非在美國本土。
可參考本部落格報導:
根據以上案例意旨,本案的實質證據支持ITC調查,判定(判決文列舉事證顯示真的有很嚴格的調查,特別是對證據中的字字珠璣):
2021年4月22日 星期四
被告產品沒有的功能,就不能均等讀入 - Olaf Soot Design, LLC v. Daktronics, Inc. (Fed. Cir. 2021)
於是,法院就根據以上原則解釋元件'h'的專利範圍,其中,根據請求項字面意思,以及說明書內容,顯然"hollow hub"與"hollow drum"為分開的兩個元件。
如此可知,就法院解釋均等論來看,至少功能上也要比到,也不能不當地從專利範圍刪掉特定元件,而不是字面上都有,雖有些差異,好像可以讀入就讀入。
可參考過去筆記:侵權比對分析筆記(https://enpan.blogspot.com/2014/09/blog-post_12.html),其中我國侵害鑑定流程顯示,想要適用均等論,前提示,要先符合「全要件原則」。






















