法規解析
USPTO公告新版顯而易見性審查指南(下)

整理/北美智權法規研究組 黃蘭閔

2010.11.05

北美智權專利法規研究組簡介
北美智權專利法規研究組,專門研究各國專利法規詳細規定,及其變動後的影響,並持續關注各國專利局最新動向。

北美智權專利法規研究組研究範圍涵蓋美國、中國、歐洲、台灣與其他重要國家的專利法規。

USPTO於2010年9月1日公告新版顯而易見性審查指南2010 KSR Guidelines Update,其內容並自公告日起開始生效。此次新版指南整理出20件判例,另外也篩選4件判例,說明相關證據的考慮原則。上一期的智權報已先介紹有關「先前技術元件的組合」和「習知元件的簡單置換」兩部分共13件判例之教示重點;這一期的智權報會繼續介紹「顯而易見的嘗試」及「相關證據考慮原則」等11件判例的教示重點。

新版指南篩選的24個判例都附有教示重點,用意是方便使用者分辨各判例相關主題。雖然如此,但USPTO強調,使用時仍應參考個別判例完整的案情討論內容,審查委員不應單憑教示重點作出核駁。


  • 顯而易見的嘗試
  • 判例

    教示重點

    英文原文

    In re Kubin

    A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the "predictable" arts.

    Takeda Chem. Indus. v. Alphapharm Pty., Ltd.

    A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound.

    Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc.

    Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives.

    Bayer Schering Pharma A.G. v. Barr Labs., Inc.

    A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable.

    Sanofi-
    Synthelabo v. Apotex, Inc.

    A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable.

    Rolls-Royce, PLC v. United Technologies Corp.

    An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness.

    Perfect Web Techs., Inc. v. InfoUSA, Inc.

    Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.


  • 相關證據考慮原則
  • 判例

    教示重點

    英文原文

    PharmaStem Therapeutics, Inc. v. ViaCell, Inc.

    Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness may be outweighed by contradictory evidence in the record or by what is in the specification. Although a reasonable expectation of success is needed to support a case of obviousness, absolute predictability is not required.

    In re Sullivan

    All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented.

    Hearing Components, Inc. v. Shure Inc.

    Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated.

    Asyst Techs., Inc. v. Emtrak, Inc.

    Evidence of secondary considerations of obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art.


    新版指南其他重點 TOP

    過去申請人若遇到顯而易見核駁,答辯時往往會提出先前技術的反面教示、說明先前技術的組合套用欠缺合理的成功預期,又或論證其發明可產生超乎預期的效果。儘管審查標準略有變化,但後KSR時代仍可繼續由這些舊有面向切入答辯,甚至其重要性可能更勝以往。

    新版指南指出,若USPTO局內人員選用KSR案7種論述邏輯作成顯而易見核駁,即需遵從MPEP有關各項核駁理由的運用指示,並符合必要的各項事實認定要件。案卷記錄中所存證據不見得需有組合先前技術的明白教示或動機,但審查委員一定要詳述理由,解釋所請發明為何在發明當時已為該技術領域具通常知識者所顯而易見。

    7種論述邏輯各有一定的滿足要件,審查委員使用任何一種論述邏輯時,都需說明為何已充分符合核駁所需各項事實認定要件,否則,即未構成所請發明顯而易見的表面證據。若官方核駁欠缺該項論述邏輯所需的任一項認定要件,申請人應於答辯時反映此一問題,而後USPTO審查委員若無法補足所欠要件,即應撤回原核駁處分。不過,如In re Kubin案的裁示,審查委員不能單因一發明屬於變數較多、不可預期的技術領域,就決定撤銷顯而易見核駁。

    此外,新版指南篩選的24個判例都附有教示重點,用意是方便使用者分辨各判例相關主題。雖然如此,但USPTO強調,使用時仍應參考個別判例完整的案情討論內容,審查委員不應單憑教示重點作出核駁。

    另方面,未來顯而易見性判斷標準勢必會再有進一步變化發展,故USPTO鼓勵該局同仁注意Fed. Cir.及BPAI判例動向。這個建議,一般美國專利申請人同樣值得參考。

     


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