依據美國專利法101條規定「任何人發明或發現任何新與有用的程序、機構、製品、組合物或以上各項新穎而有用的改良，符合本條要件時，即可獲准專利」。然而，美國累積的法院判決先例中，明確的指出了自然法則、抽象概念、科學原理非可專利標的。
在2012年，Prometheus Laboratories, Inc. v. Mayo Collaborative Services的最高法院判決中。最高法院認為普羅米修斯實驗室所主張之投藥方法專利僅為自然法則本身，因此非專利法101條所認可之專利標的。
在Prometheus判決後，美國專利局加強了含有自然原則的方法請求項的
審查。本文作者基於Prometheus判決，欲了解其對醫療檢測方法的影響。
基於司法判決及審查基準，作者認為撰寫醫療檢測方法請求項時須注意僅在步驟中撰寫被認定是單純的自然原則尚不足夠，還需增加額外步驟。額外的步驟不能只是廣泛被認定公眾步驟，例如提供一檢體或對病患投藥或是會被認定是人的心智步驟例如比照對照組步驟步驟。
此外，申請者需思考是否在發現一自然法則的過程中，有特定的限制手段，足以讓請求項未含所有的自然法則的應用，並且考慮是否具有含有人為的產物的發明。因為基於判決先例，使用人為產物的方法或製造人為產物的方法屬於可以專利的標的。

In accordance with the U.S. Patent Law 35 USC 101 “Whoever invents or discovers any new and useful process ,machine, manufacture, or composition of matter, or any new and useful improvement thereof ,may obtain a patent therefor, subject to the conditions and requirements of this title.” However, pluralities of precedents have set a principle that nature law, abstract idea and scientific principle are exceptions under the 35 USC101.
In 2012, the Supreme Court made a decision on the Prometheus Laboratories, Inc. v. Mayo Collaborative Services Case. The Supreme Court judged that the drug administer method claims owned by Prometheus Laboratories, Inc are nature law. The case is considered to effect the medical treatment related procedures for applying patent. Therefore, the main object of the research is to analyze the rules for recognizing patentable medical measuring procedures and unpatentable nature law after Prometheus Case.
According to the decisions and the guideline related to Prometheus Case, it shall be noticed that a medical measuring method claim merely describe a nature law is not enough. The claim should include extra steps which are not considered as insignificant steps. Such extra steps cannot be just steps that are merely conventional such as providing a sample, administering drug to a patient, or steps that are merely mental act such as comparing control group with the test group.
Writers should think about if there are some specific limitations to make the claim not to preempt every applications of the nature law. Furthermore, it should be considered whether a claim includes artificial product or artificial composition of matter or not. If a method claim includes nature law and steps relating to a specific artificial product, such as making steps of the product, the claim is considered to be a patentable subject matter referring to precedents.

摘要I
ABSTRACTII
致謝I
目錄I
表目錄IV
第一章緒論1
1.1研究動機1
1.2 研究目的2
1.3 研究架構2
1.4研究方法3
第二章名詞定義以及法源概論4
2.1 相關名詞定義4
2.1.1醫療檢測方法之定義4
2.1.2自然原則及自然法則之定義4
2.2 美國方法專利適格性之法源概論5
第三章美國方法類專利適格性判決之回顧9
3.1 強調先占測試概念的BENSON-「數字轉化之電腦程式」事件-19729
3.2建立無意義的後續步驟原則的FLOOK-「化學催化反應中，警示值更新方法」事件- 197814
3.3強調太陽底下的任何人為的事物均為專利標的之CHAKRABARTY-「可分解原油之人造細菌」事件-198020
3.4 含有電腦程式應用的DIEHR-「合成橡膠的製造方法」事件-198122
3.5 CCPA建立的FWA測試法之起源的FREEMAN「電腦符號的設定方法」事件-197825
3.6 FWA測試法中之WALTER「地震偵測方法」事件-198028
3.7 FWA測試法中之IN RE ABELE-「斷層攝影掃描法」事件-198231
3.8 忽略專利適格性判斷之METABOLITE LABORATORIES, INC-維生素缺乏之檢測方法事件-200433
3.9 否決上訴法院M OR T 測試為唯一標準之BILSKI-「降低匯差損害風險的方法」事件-201036
3.10討論醫療方法專利適格性之CLASSEN 免疫醫療公司-「嬰幼兒疫苗配合日程的接種方法」事件-201140
3.11本章小結44
第四章PROMETHEUS事件與其影響48
4.1PROMETHEUS實驗室事件相關發展48
4.1.1事實48
4.1.2法院主張的變化 地方法院階段50
4.2法院的回應62
4.2.1 同時包含心智步驟以及不符合M or T 測試法之SmartGene「醫療飲食療的選擇之導引方法」事件 -2012.362
4.2.2 同時不符合自然法則以及M or T 測試法Sequenom 公司之「非侵入式的產前檢測方法」事件-2012.767
4.2.3 抽象的心智步驟的Myriad Genetics之「偵測突變DNA序列的檢測方法」事件-2012.869
4.2.4 屬於心智步驟及自然法則且不符合機械或轉換測試法之Intema公司「一種用以決定胎兒罹患有唐氏症的風險的非侵入式篩選方法」-2012.1175
4.3 美國專利局的回應與態度81
4.3.1 審查指南的頒布81
4.4美國請求項撰寫之探討83
第五章總結90
5.1 法院主張變化90
5.2 美國請求項撰寫的建議91
5.2.1 與發明者討論其發明時91
5.2.2 撰寫請求項時之思考92
第六章討論93
6.1發現新且有用的程序與發現自然原則之比較93
6.2美國專利局審查指南與最高法院的判決概念是否一致95
參考文獻97

一、參考書目
中文書目及期刊 (依出版年份順序)
1.楊代華，生物科技與醫療發明專利，元照出版公司，2008年10月初版
2.鄭中人，專利法規釋義，考用初版股份有限公司，2009年 3月初版
3.何美瑩、鄭中人等，變動中的可專利客體適格性判斷標準，載: 專利師，中華民國專利師公會出版，頁23-56，2012年7月
4.黃文儀，專利實務第一冊，三民總經銷，2012年8月第五版
5.陳歆，美國專利訴訟關鍵案例解讀，元照出版公司，2012年9月初版
6.劉國讚，專利權範圍之解釋與侵害，元照出版公司， 2012年10月二版

國外書目及期刊
1.Eddy Ventose，Medical Patent Act-the challenge of medical treatment，Edward Elgar Publishing,Inc.(2011)



二、參考美國判決(依年份順序)
1.Le Roy v. Tatham, 55 U.S. 156, 14 How. 156, 1852 WL 6775 (U.S.N.Y.), 14 L.Ed. 367 (1852)
2.Corning v. Burden,56 U.S. 252, 15 How. 252, 1853 WL 7631 (U.S.N.Y.), 14 L.Ed. 683(1853)
3.O’Reilly v. Morse, 56 U.S. 62, 15 How. 62, 1853 WL 7642 (U.S.Ky.), 14 L.Ed. 601 (1853)
4.Morton v New York Eye Infirmary, 5 Blatchf. 116, 2 Am. Law Reg. (N.S.) 672, 17 F.Cas. 879 (1862)
5.Rubber-Tip Pencil Co. V. Howard, 87 U.S. 498, 1874 WL 17428 (U.S.N.Y.), 22 L.Ed. 410, 20 Wall. 498 (1874)
6.Cochrane v. Deener, 94 U.S. 780, 4 Otto 780, 1876 WL 19544 (U.S.Dist.Col.), 24 L.Ed. 139 (1876)
7.Tilghman v. Proctor, 102 U.S. 707, 12 Otto 707, 1880 WL 18737 (U.S.Ohio), 26 L.Ed. 279 (1880)
8.Dolbear v. American Bell Tel. Co. 126 U.S. 1, 8 S.Ct. 778, 31 L.Ed. 863(1888)
9.Dolbear et al v. Molecular Tel.Co et al, 126 U.S. 1, 534, 8 S.Ct. 778, 782(1888)
10.Expanded Metal Co. V. Bradford, 214 U.S. 366, 29 S.Ct. 652, 53 L.Ed. 1034 (1909)
11.United States v. Dubilier Condenser Corp, 289 U.S. 178, 53 S.Ct. 554, 85 A.L.R. 1488, 77 L.Ed. 1114, 17 U.S.P.Q. 154 (1933)
12.Mackay Radio & Telegraph Co. v. Radio Corporation of America, 306 U.S. 86, 306 U.S. 618, 59 S.Ct. 427, 83 L.Ed. 506, 40 U.S.P.Q. 199 (1939)
13.Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 68 S.Ct. 440, 92 L.Ed. 588, 76 U.S.P.Q. 280 (1948)
14.Gottschalk v. Benson, 409 U.S. 63, 93 S.Ct. 253, 34 L.Ed.2d 273, 175 U.S.P.Q. 673 (1972)
15.In re Christensen, 478 F.2d 1392, 178 USPQ 35 (Cust. & Pat.App.1973)
16.In re Chatfield, 545 F.2d 152, 158 (Cust. & Pat.App.1976)
17.Parker v. Flook, 437 U.S. 584, 98 S.Ct. 2522, 57 L.Ed.2d 451, 198 U.S.P.Q. 193 (1978)
18.Application of Freeman, 573 F.2d 1237, 197 U.S.P.Q. 464 (1978)
19.Application of Bergy, 596 F.2d 952, 201 U.S.P.Q. 352 (1979)
20.Diamond v.Chakrabarty, 447 U.S. 303, 100 S.Ct. 2204, 65 L.Ed.2d 144, 206 U.S.P.Q. 193 (1980)
21.Application of Walter, 618 F.2d 758,205 U.S.P.Q. 397(1980)
22.Diamond v. Diehr , 450 U.S. 175, 101 S.Ct. 1048, 67 L.Ed.2d 155, 209 U.S.P.Q. 1 (1981)
23.In re Abele, 684 F.2d 902,214 U.S.P.Q. 682,(1982)
24.In re Grams, 888 F.2d 835, 58 USLW 2328, 12 U.S.P.Q.2d 1824 (1989)
25.Arrhythmia Research Technology, Inc. v. Corazonix Corp , 958 F.2d 1053, 60 USLW 2603, 22 U.S.P.Q.2d 1033 (1992)
26.In re Alappat, 33 F.3d 1526, 63 USLW 2088, 31 U.S.P.Q.2d 1545 (1993)
27.Metabolite Laboratories, Inc. V. Laboratory Corp. of America Holdings , 370 F.3d 1354, 71 U.S.P.Q.2d 1081 (2004)
28.In re Bilski, 545 F.3d 943, 2008-2 USTC P 50,621, 88 U.S.P.Q.2d 1385 (2008)
29.Prometheus Laboratories, Inc v.Mayo Collaborative Services, 581 F.3d 1336, 92 U.S.P.Q.2d 1075 (2009)
30.Bilski v. Kappos, 130 S.Ct. 3218, U.S.P.Q.2d 1001 (2010)
31.Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, 97 U.S.P.Q.2d 1097 (2010)
32.Classen Immunotherapies, Inc. v. Biogen, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (2011)
33.Ass'n For Molecular Pathology v. U.S. Patent And Trademark Office, 653 F.3d 1329, 99 U.S.P.Q.2d 1398 (2011)
34.Aria Diagnostics, Inc., V.Sequenom, Inc,2012 WL 2599340 (2012)
35.Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189 (2012)
36.Smartgene, Inc. v. Advanced Biological Laboratories, SA,852 F.Supp.2d 42 (2012.3)
37.The Association For Molecular Pathology, V. United States Patent And Trademark Office, 689 F.3d 1303, 103 U.S.P.Q.2d 1681 (2012.8.16)
38.PerkinElmer, Inc. v. Intema Ltd., 496 Fed.Appx. 65, 2012 WL 5861658 (C.A.Fed. (Mass.)), 105 U.S.P.Q.2d 1960 (2012.11)
39.Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 1747, 81 USLW 3554 (2013.4.1)
40.Association for Molecular Pathology v. Myriad Genetics, Inc., 2013 WL 2631062 (2013.06.13)


美國訴願決定案(依年份順序)
1.Ex Parte Kettering, 35 USPQ 342 (POBA,1936)
2.EX Parte Brinkerhoff,1883, reprinted in 27 JPOS 797 (POBA,1945)
3.Ex Parte Scherer,103 USPQ 107 (POBA,1954)

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3.US4740470 Biologically functional molecular chimeras
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