Sequenom's Petition for a writ of certiorari (March 21, 2016)
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F. 3d 1282 (Fed. Cir., December 2, 2015) (rehearing en banc denied)
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F. 3d 1371 (Fed. Cir., June 12, 2015)
US 6258540, "Non-invasive prenatal diagnosis"
美國聯邦最高法院在6月27日駁回了Sequenom的上訴請求，確認了聯邦巡迴上訴法院去年認為Sequenom的cffDNA相關請求項不是可專利標的的見解。本案對DNA相關技術是否為專利是格標的的影響甚鉅，許多生技廠商都請律師呈交法院意見書給聯邦最高法院，可見此案的重要性。以下簡單整理本案的重點供參。
申請專利範圍
當年 (最早的優先權日可以追溯到1997年) 寫專利說明書的人，很努力地嘗試用各種不同的方法撰寫方法項，包括兩項偵測方法，以及一項診斷方法，但19年後，法院認為這些寫法全都不行，沒有一項適格：
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
24. A method for detecting a paternally inherited nucleic acid on a maternal blood sample, which method comprises:
removing all or substantially all nucleated and anucleated cell populations from the blood sample,
amplifying a paternally inherited nucleic acid from the remaining fluid and subjecting the amplified nucleic acid to a test for the Paternally inherited fetal nucleic acid.
25. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises
obtaining a non-cellular fraction of the blood sample
amplifying a paternally inherited nucleic acid from the non-cellular fraction and
performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid.
法院推論過程
Mayo測試法第一步
1. cffDNA的存在是自然現象 (這點雙方不爭執)：
1. cffDNA的存在是自然現象 (這點雙方不爭執)：
It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon.788 F. 3d at 1376.
2. 請求項從開始到結束都關於cffDNA，因此 "指向" 自然發生的物質：
The method therefore begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring.
788 F. 3d at 1376.
3. 說明書也多處支持請求項"指向" 自然發生的物質 (這邊建議看判決原文，並參考原說明書，看看到底是寫了甚麼)：
Mayo測試法第二步
1. cffDNA的偵測與擴增方法，在1997年時都是習知的，所以請求項相當於 "指示醫生用舊方法偵測cffDNA"：
2. 說明書的內容也多處確認了準備與擴增血漿或血清中的DNA序列，在1997年時就是舊技術：
3. 專家證人也說擴增DNA的技術在1997年時就是舊的：
4. 申請歷史過程中，申請人自己也說偵測DNA的技術是舊的：
結論：用舊方法應用自然產物不是可專利標的
請求項到底應該怎麼寫？
重點來了：如果照本案的見解，那麼 "新發現的應用" 幾乎都沒辦法申請專利了。因為所謂 "新發現"，所發現的客體其實多半都已經存在在這世界上了，只是現在有人發現它而已；至於應用這個新發現，多半用的方法也是已知的方法。
可是往往這個發現，真的是出乎意料，而且很有用啊。比如本案就是這個狀況。難道沒辦法為這種新發現寫出一個適格的專利請求項嗎？
關於這個問題，其實Lourie法官在他去年12月駁回全院庭審請求的協同意見書中，提到了他的看法。他認為這個技術的創新之處，應該在於 "使用了cffDNA來診斷胎盤DNA的問題"，因此請求項應該用Jepson式強調這個 "使用"：
這其實就是所謂的 "新用途請求項 (New Use Claim)" 。這種請求項的寫法不是新的，有興趣者可以參考MPEP 2112.02 II的內容，光看標題就知道這是重點了吧。以下是MPEP 2112.02 II 的原文，我把每個觀念分段，加上判決的超連結，並以紅字與斜體強調重點：
3. 說明書也多處支持請求項"指向" 自然發生的物質 (這邊建議看判決原文，並參考原說明書，看看到底是寫了甚麼)：
The written description supports the conclusion that the claims of the '540 patent are directed to a naturally occurring thing or natural phenomenon. In the Summary and Objects of the Invention section of the '540 patent... Further, the description of the invention notes.... Thus, the claims at issue, as informed by the specification, are generally directed to detecting the presence of a naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma or serum.788 F. 3d at 1376.
Mayo測試法第二步
1. cffDNA的偵測與擴增方法，在1997年時都是習知的，所以請求項相當於 "指示醫生用舊方法偵測cffDNA"：
Using methods like PCR to amplify and detect cffDNA was well-understood, routine, and conventional activity in 1997. The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.788 F.3d at 1377.
2. 說明書的內容也多處確認了準備與擴增血漿或血清中的DNA序列，在1997年時就是舊技術：
The specification of the '540 patent confirms that the preparation and amplification of DNA sequences in plasma or serum were well-understood, routine, conventional activities performed by doctors in 1997....788 F.3d at 1377.
3. 專家證人也說擴增DNA的技術在1997年時就是舊的：
Sequenom's expert, Dr. Evans, testified at deposition that PCR and other methodologies for amplifying DNA were "already well known in science [in 1997]."788 F.3d at 1377.
4. 申請歷史過程中，申請人自己也說偵測DNA的技術是舊的：
During prosecution of the application that 1378*1378 became the '540 patent, the applicant stated:....788 F.3d at 1378.
結論：用舊方法應用自然產物不是可專利標的
Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.788 F.3d at 1378.
請求項到底應該怎麼寫？
重點來了：如果照本案的見解，那麼 "新發現的應用" 幾乎都沒辦法申請專利了。因為所謂 "新發現"，所發現的客體其實多半都已經存在在這世界上了，只是現在有人發現它而已；至於應用這個新發現，多半用的方法也是已知的方法。
可是往往這個發現，真的是出乎意料，而且很有用啊。比如本案就是這個狀況。難道沒辦法為這種新發現寫出一個適格的專利請求項嗎？
關於這個問題，其實Lourie法官在他去年12月駁回全院庭審請求的協同意見書中，提到了他的看法。他認為這個技術的創新之處，應該在於 "使用了cffDNA來診斷胎盤DNA的問題"，因此請求項應該用Jepson式強調這個 "使用"：
It is not disputed that fractionating blood, amplifying DNA, and analyzing DNA to detect specific gene sequences are known techniques in the art. As all other steps in the claims are individually well-known, the innovative aspect of the claims appears to be the improvement in the method of determining fetal genetic characteristics or diagnosing abnormalities of fetal DNA, consisting of use of the non-cellular fraction of fetal DNA obtained from a maternal blood sample.
The claim to this invention, then, might have been better drafted as a so-called Jepson claim, which recites what is in the prior art and what is the improvement. Such a claim might read, perhaps with more details added: "In a method of performing a prenatal diagnosis using techniques of fractionation and amplification, the improvement consisting of using the non-cellular fraction of a maternal blood sample."809 F. 3d at 1286. (斜體字為原文，紅字與粗體是我加上的。)
這其實就是所謂的 "新用途請求項 (New Use Claim)" 。這種請求項的寫法不是新的，有興趣者可以參考MPEP 2112.02 II的內容，光看標題就知道這是重點了吧。以下是MPEP 2112.02 II 的原文，我把每個觀念分段，加上判決的超連結，並以紅字與斜體強調重點：
II.PROCESS OF USE CLAIMS — NEW AND UNOBVIOUS USES OF OLD STRUCTURES AND COMPOSITIONS MAY BE PATENTABLE
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated.
In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. The court went on to reverse the obviousness rejection of claims 2-5 and 7-10 which recited a process of using a new compound. The court relied on evidence showing that the nonaddictive property of the new compound was unexpected.).
See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) (The claim was directed to a process of inhibiting light degradation of polypropylene by mixing it with one of a genus of compounds, including nickel dithiocarbamate. A reference taught mixing polypropylene with nickel dithiocarbamate to lower heat degradation. The court held that the claims read on the obvious process of mixing polypropylene with the nickel dithiocarbamate and that the preamble of the claim was merely directed to the result of mixing the two materials. “While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition.” 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).以上內容僅供參考。相信經過上訴法院的法官指導後，以後關於發現一種自然物質，並使用舊方法產生新用途 (幫學校或研究機構申請專利，應該會常發生這種狀況)，相關的請求項就比較清楚應該怎麼寫了吧。
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