我國產業政策是將醫療影像列為重點發展項目之一，所謂醫學影像係指為醫療行為或醫學研究，對人體構造或局部器官，以非侵入方式取得內部組織影像的技術，其中包括超音波掃描器、數位X光機、磁振造影儀等高階醫療器材。再者醫學影像約為705億，占全球醫療器材市場的25.8%，而且美國為全球最大醫療器材市場的國家。
然而，經由我國海關進出口的統計，高階醫療器材大多倚賴國外進口，我國僅有超音波掃描器具持續且穩定輸出至新興國家。其次根據我國核准專利件數統計，專利權人多為學校或研發機構，而且除了國際醫學器材廠商皆未向我國申請醫學影像專利，國內醫學器材廠商也沒有申請專利，顯示醫學影像的技術門檻高以及我國研究成果尚未銜接國內企業與競爭市場。
本研究先探討美國與我國醫學影像之可專利標的，藉鏡美國專利局的審查制度與法院見解，以供我國智慧財產局與智慧財產法院參考。其次提出本體論的方法，用以篩選專有名詞並建立醫學影像的本體論；專利檢索策略與布局方法。最後藉由醫學影像之本體論檢索美國與臺灣核准專利件數以及結合專利分類號製作專利地圖，分析醫學影像技術的研發趨勢。

The medical imaging technology is one of the core developing industries that is being promoted by the Taiwan government. The medical imaging is to acquire useful information about the physiological processes or organs of the body by using non invasive methodologies, such as ultrasound, X-ray, magnetic resonance imaging, and other high-level medical imaging devices. In addition, a survey conducted by the government-backed Industrial Technology Research Institute indicates that the market for high-level medical imaging devices is worth US$70.5 billion, accounting for 25.8% of total global sales of medical equipment; the United States is the biggest market research companies around the world.
Based on the trade statistics conducted by the Taiwan Customs Bureau, except ultrasonic apparatus, made in Taiwan and exported to the emerging countries steadily, however, most of high-level medical imaging devices are imported from the United States and European. Moreover, according to the number of issued patents stated by Taiwan Intellectual Property Office, most of assignee is school or research institutes. In Taiwan, neither international nor domestic medical device companies did file patent application that indicates the high hurdle or high entrance barrier technique of medical imaging and the gap among research results, domestic medical device companies and competitive market.
The primary purpose of this research is to investigate patentable subject matter of the medical imaging in the United States and Taiwan, by referring to the opinions of the Supreme Court of the United States and the Manual of Patent Examining Procedure of the US Patent and Trademark Office, so as to suggest Taiwan Intellectual Property Courts and Taiwan Intellectual Property Office. The secondary objective of this research is to effectively extract domain-specific patents using an ontology, which contains specific domain concepts and helps researchers to understand the relationships between concepts, and create domain-specific ontologies of medical imaging, in order to gain a quick snapshot of their own patent portfolio and identify potential technology clusters. Finally, the methodologies in this research search the issued patents from the US Patent and Trademark Office to Taiwan Intellectual Property Office through the domain-specific ontology of medical imaging, and build up a patent map with the domain-specific ontology f medical imaging and the patent code for future trend in medical imaging technology.

摘要I
AbstractII
致謝III
目 　 錄IV
圖 目　錄VI
表 目　錄VIII
第一章緒論1
1.1研究背景1
1.2研究動機2
1.3研究目的3
1.4研究方法與架構4
1.5研究範圍與限制6
第二章我國醫學影像之產業概述7
2.1全球醫學影像之產業發展7
2.1.1全球醫療器材市場之產品概況7
2.1.2各國醫療器材市場之發展規模8
2.2美國醫療器材產業概況9
2.2.1美國醫療器材市場之產品概述9
2.2.2美國主要國際廠商之發展動向10
2.3我國醫學影像產業之發展趨勢11
2.3.1我國醫學影像產業之進出口概況11
2.3.2國內廠商之發展動向12
2.4小結12
第三章探討醫學影像之可專利標的14
3.1國際專利公約之訂定14
3.1.1巴黎公約之簽署14
3.1.2TRIPs協定之修正15
3.1.3我國因應措施16
3.2探討我國醫學影像之可專利標的17
3.2.1專利權之法源依據17
3.2.2醫學影像之可專利標的18
3.2.3相關法院案例20
3.3探討美國醫學影像之可專利標的22
3.3.1法定不予專利標的之範疇22
3.3.2相關法院案例24
3.3.3相關訴願案例29
3.4小結31
第四章醫學影像之專利技術分析與佈局33
4.1專利技術檢索策略與佈局理論33
4.1.1本體論33
4.1.2專利檢索策略35
4.1.3專利分析與佈局方法38
4.1.4醫學影像之本體論建構39
4.1.5醫學影像之檢索步驟43
4.2醫學影像之專利分析與佈局45
4.2.1醫學影像之產業趨勢分佈45
4.2.2相關技術公司之研發活動分析50
4.3超音波影像之專利分析與佈局68
4.3.1歷年技術分佈趨勢分析68
4.3.2相關技術公司之研發活動分析69
4.4X光成像之專利分析與佈局82
4.4.1歷年技術分佈趨勢分析82
4.4.2相關技術公司之研發活動分析83
4.5磁振造影之專利分析與佈局85
4.5.1歷年技術分佈趨勢分析85
4.5.2相關技術公司之研發活動分析86
4.6小結87
第五章結論與未來展望89
5.1結論89
5.2未來展望92
參考文獻93

中文部分
期刊
李健興等人，基於Ontology之專案監控知識管理之研究，國立臺南大學「理工研究學報」第40卷第1期，頁69-87(2006)。
書籍
劉國讚，專利法之理論與實務，元照出版公司，頁19(2012)。
魯明德，解析專利資訊，全華圖書股份有限公司，頁30(2010)。
賴榮哲，專利分析總論，翰蘆圖書出版社，頁553-554(2002)。
陳達仁、黃慕萱，專利資訊檢索、分析與策略，華泰文化事業股份有限公司，頁168-266(2009)。
張映慈等人，美國醫療器材產業概況，2012臺灣醫療器材產業年鑑，ITIS研究報告，頁22(2012)。
經濟部智慧財產局，專利法逐條釋義，經濟部智慧財產局，頁38-40(2009)。
研討會論文
劉尚志，中小企業專利管理的策略與方法，產業科技研究發展管理研討會論文集，頁20-25(1998)。
學位論文
吳東璋，多模式影像對位與融合技術之研究-以金花石蒜鱗莖影像為例，國立臺灣大學生物產業機電工程學系碩士論文，臺北(2010)。
研究報告
黃茂榮，稅捐減免與經濟發展在臺灣之研究成果報告，行政院國家科學委員會專題研究計畫成果報告(編號：NSC －95-2414-H-002-012)，頁25，臺北，臺灣(2007)。
網站
行政院經濟建設委員會，產官聯手揮軍高階影像醫材，取至 http://www.cepd.gov.tw/m1.aspx?sNo=0016221(瀏覽日期：2013/06/05)。
經濟部工業局，醫療器材產業產值創千億，加速產業升級轉型，取至 http://www.moea.gov.tw/Mns/populace/news/News.aspx?kind=1&menu_id=40&news_id=24394(瀏覽日期：2012/11/12)。
外文部分
期刊
Huang, CJ, Trappey, AJC & Wu, CY, Develop a Formal Ontology Engineering Methodology for Technical Knowledge Definition in R&D Knowledge Management, Advanced Concurrent Engineering, Vol.12, pp.495-502(2008).
GRUG NINGER, M. & FOX, M., Methodology for the design and evaluation of ontologies. Proceedings of the orkshop on Basic Ontological Issues in Knowledge Sharing held in Conjunction with IJCAI-95, Montreal, Canada (1995).
書籍
Feldman, R., Fresko, M., Hirsh, H., Aumann, Y., Liphstat, O., Schler, Y. and Rajman, M, Knowledge Management: A Text Mining Approach. Proceedings of the 2nd PAKM, Basel, Switzerland(1998).
Manning C. and Schutze H, Foundations of Statistical Natural Language Processing, MIT Press(1999).
討會論文
Byungun Yoon, Robert Phaal, and David Probert, Structuring Technological Information for Technology Roadmapping: Data Mining Approach, 7th WSEAS Int. Conf. on ARTIFICIAL INTELLIGENCE, KNOWLEDGE ENGINEERING and DATA BASES(2008).
研究報告
Noy NF and McGuinness DL, Ontology development 101: A guide to creating your first ontology, SMI technical report, Stanford University(2001).
美國法規
A game defined as a set of rules, Manual of Patent Examining Procedure, United States Patent and Trademark Office.
a human per se, The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 Stat. 284 (2011)
S.Rep.No.1979, 82d Cong., 2d Sess., 5 (1952); H.R.Rep.No.1923, 82d Cong., 2d Sess., 6 (1952), U.S.Code Cong. & Admin.News 1952, pp. 2394, 2399.
Act of Feb. 21, 1793, ch. 11, § 1, 1 Stat. 318.
美國訴願
Ex parte EDWARD K.Y. JUNG et al, Final Decisions of the Patent Trial and Appeal Board(2013).
Ex parte IVAN SALGO et al, Final Decisions of the Patent Trial and Appeal Board (2013).
美國判決
409 U.S., at 70, 93 S.Ct., at 256.
A company, Ferguson, 558 F.3d at 1366.
A computer program per se, Gottschalk v. Benson, 409 U.S. at 72.
A legal contractual agreement between two parties, see In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, ___ (Fed. Cir. 2009) (cert. denied)
A mere arrangement of printed matter, In re Miller, 418 F.2d 1392, 1396, 164 USPQ 46, ___ (CCPA 1969)
A naturally occurring organism, Chakrabarty, 447 U.S. at 308
Bilski v. Kappos, 130 S.Ct. 3218(2010).
Cochrane v. Deener, 94 U.S. 780, 787-788, 24 L.Ed. 139 (1877).
Diamond v. Chakrabarty, 447 U.S. 303, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980).
Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, ___ (1980)
Diamond v. Diehr, 450 U.S. 175 (1981).
Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948).
Funk Bross. Seed Co. v. Kalo, 333 U.S. 127, 130, 68 S.Ct. 440, 441, 92 L.Ed. 588
Gottschalk v. Benson, 409 U.S. 63 (1972).
In Corning v. Burden, 15 How. 252, 267-268, 14 L.Ed. 683 (1854).
In re Nuijten, 500 F.3d 1346, 1357, 84 USPQ2d 1495, ___ (Fed. Cir. 2007)
Le Roy v. Tatham, 14 How. (55 U.S.) 156, 175, 14L.Ed. 367.
Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852).
Mackay Co. v. Radio Crop., 306 U.S. 86, 94, 59 S.Ct. 427, 431, 83L.ed. 506.
Parker v. Flook 437 U.S. 584 (1978)
Perrin v. United States, 444 U.S. 37, 42, 100 S.Ct. 311, 314, 62 L.Ed.2d 199 (1979).
Rubbrt-Tip Pencil Co. v. Howard, 20 Wall(87 U.S.) 498, 507, 22L.Ed. 410.
State Street Bank & Trust Co. v. Signature Financial Group Inc., 149 F.3d 1368.