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USPTO公告新版显而易见性审查指南
整理╱北美智权法规研究组 黄兰闵
2010/12/30

2010年9月1日USPTO公告新版显而易见性审查指南2010 KSR Guidelines Update,其内容并自公告日起开始生效。
新版指南归纳KSR v. Teleflex案及3年来美国联邦巡回上诉法院(US Court of Appeals for the Federal Circuit,Fed. Cir.)相关判例,摘录其法院诠释,注记实务审查要点,并要求USPTO审查人员参照2007年编写的旧有审查指南2007 KSR Guidelines,以于审查专利申请案显而易见性问题时作成应有的判断。

新版指南公告背景

讨论美国专利制度的Obviousness Inquiry,即检验一美国专利或申请案的所请发明(claimed invention)是否显而易见,2007年4月宣判的KSR案当属关键指标。在美国最高法院宣布KSR案判决结果之后,USPTO的审查标准及申请人答辩方向都有相当幅度的调整。

简言之,美国最高法院藉本案再度强调「葛兰氏四要素」(Graham’s factors)的检验原则,也就是说,判断所请发明是否显而易见时,需先确认先前技术的内容范围、所请发明与先前技术的差异、该技术领域通常知识水平,并考虑其它辅助因素。「教导-建议-动机判断标准」(teaching-suggestion-motivation (TSM) test)只是其中一种可能的参考指标,且一发明是否显而易见,应就个案各项事实综合考虑。

2007年版的旧有审查指南内容,现已并入MPEP第2143、2144两节。当时USPTO即从KSR判决文整理出一发明可能属显而易见的7项参考指标,也可视作是论证一发明为显而易见的7套论述逻辑,包括:

  1. 套用习知方式组合先前技术组件,并产生可预期的效果;
  2. 一习知组件简单置换为另一习知组件,并产生可预期的效果;
  3. 套用习知技术,以同样方法改善类似装置、方式、产品;
  4. 改良一习知装置、方式、产品的条件已臻成熟,在此一习知装置、方式、产品套用习知技术,并产生可预期的效果;
  5. 显而易见的尝试 - 已经提示而可预期的解决方式有限(a finite number of identified, predictable solutions),只需从中选择,且会有合理的成功预期;
  6. 一研究领域之习知成果(known work in one filed of endeavor),经过设计诱因或其它市场力量的刺激,本来就有可能催生出适用于相同或不同研究领域、但未超乎所请发明技术领域具通常知识者预期的变体(variation);
  7. TSM判断标准。

而此次新版指南又整理出20件判例,分别用以说明前述第1、2、5项参考指标的运用方式。另外也筛选4件判例,说明相关证据的考虑原则。

24件判例教示重点

  • 先前技术组件的组合

判例

教示重点英文原文

In re Omeprazole Patent Litigation

Even where a general method that could have been applied to make the claimed product was known and within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown.

Crocs, Inc. v. U.S. Intl Trade Commn.

A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results.

Sundance, Inc. v. DeMonte Fabricating Ltd.

A claimed invention is likely to be obvious if it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they have been combined.

Ecolab,Inc. v. FMC Corp.

A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do so.

Wyers v. Master Lock Co.

The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.

Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended purpose. An inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.

  • 习知组件的简单置换

判例

教示重点英文原文

In re ICON Health & Fitness, Inc.

When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved.

Agrizap, Inc. v. Woodstream Corp.

Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that would have been recognized by those of ordinary skill in the art as useful for applicant’s purpose.

Muniauction, Inc. v. Thomson Corp.

Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for those functions.

Aventis Pharma Deutschland v. Lupin, Ltd.

A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art.

Eisai Co. Ltd. v. Dr. Reddys Labs., Ltd.

A claimed compound would not have been obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead compound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain the claimed compound.

Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc.

It is not necessary to select a single compound as a ‘‘lead compound’’ in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious.

Altana Pharma AG v. Teva Pharms. USA, Inc.

Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound.

  • 显而易见的尝试

判例

教示重点英文原文

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.

  • 相关证据考虑原则

判例

教示重点英文原文

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.


新版指南其它重点

过去申请人若遇到显而易见核驳,答辩时往往会提出先前技术的反面教示、说明先前技术的组合套用欠缺合理的成功预期,又或论证其发明可产生超乎预期的效果。尽管审查标准略有变化,但后KSR时代仍可继续由这些旧有面向切入答辩,甚至其重要性可能更胜以往。

新版指南指出,若USPTO局内人员选用KSR案7种论述逻辑作成显而易见核驳,即需遵从MPEP有关各项核驳理由的运用指示,并符合必要的各项事实认定要件。案卷记录中所存证据不见得需有组合先前技术的明白教示或动机,但审查委员一定要详述理由,解释所请发明为何在发明当时已为该技术领域具通常知识者所显而易见。

7种论述逻辑各有一定的满足要件,审查委员使用任何一种论述逻辑时,都需说明为何已充分符合核驳所需各项事实认定要件,否则,即未构成所请发明显而易见的表面证据。若官方核驳欠缺该项论述逻辑所需的任一项认定要件,申请人应于答辩时反映此一问题,而后USPTO审查委员若无法补足所欠要件,即应撤回原核驳处分。不过,如In re Kubin案的裁示,审查委员不能单因一发明属于变量较多、不可预期的技术领域,就决定撤销显而易见核驳。

此外,新版指南筛选的24个判例都附有教示重点,用意是方便使用者分辨各判例相关主题。虽然如此,但USPTO强调,使用时仍应参考个别判例完整的案情讨论内容,审查委员不应单凭教示重点作出核驳。

另方面,未来显而易见性判断标准势必会再有进一步变化发展,故USPTO鼓励该局同仁注意Fed. Cir.及BPAI判例动向。这个建议,一般美国专利申请人同样值得参考。