オフィスアクション
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Teaching point |
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Combining Prior Art Elements |
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In re Omeprazole Patent
Litigation,536 F.3d 1361 (Fed. Cir. 2008). |
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. |
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Crocs, Inc. v. |
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. |
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Sundance, Inc. v. DeMonte FabricatingLtd., 550
F.3d 1356 (Fed.Cir. 2008). |
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. |
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Ecolab, Inc. v. FMC Corp., 569F.3d 1335
(Fed. Cir. 2009). |
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 todo so. |
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Wyers v. Master Lock Co., No.2009-1412,
--F.3d--, 2010 WL2901839 (Fed. Cir. July 22, 2010). |
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. |
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DePuy Spine, Inc. v. Medtronic Sofamor Danek,
Inc., 567 F.3d1314 (Fed. Cir. 2009). |
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. |
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Substituting One Known
Element for Another |
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In re ICON Health
& Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007). |
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. |
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Agrizap, Inc. v. Woodstream
Corp., 520 F.3d 1337 (Fed. Cir. 2008). |
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. |
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Muniauction, Inc. v. Thomson Corp., 532
F.3d 1318 (Fed. Cir. 2008). |
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. |
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Aventis Pharma Deutschland v.Lupin, Ltd., 499 F.3d 1293 (Fed. Cir. 2007). |
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. |
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Eisai Co. Ltd. v. Dr. Reddy's
Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008). |
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. |
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Procter & Gamble
Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989
(Fed. Cir. 2009). |
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. |
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Altana Pharma AG v. Teva Pharms.
USA, Inc., 566 F.3d 999 (Fed. Cir. 2009). |
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. |
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The Obvious To Try Rationale |
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In re
Kubin, 561 F.3d 1351 (Fed. Cir. 2009). |
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. |
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Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492
F.3d 1350 (Fed. Cir. 2007). |
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. |
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Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520
F.3d 1358 (Fed. Cir. 2008). |
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. |
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Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575
F.3d 1341 (Fed. Cir. 2009). |
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. |
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Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d
1075 (Fed. Cir. 2008). |
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. |
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Rolls-Royce, PLC v. United Technologies Corp., 603
F.3d 1325 (Fed. Cir. 2010). |
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. |
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Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d
1324 (Fed. Cir. 2009). |
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. |
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Consideration of Evidence |
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PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d
1342 (Fed. Cir. 2007). |
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. |
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In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007). |
All evidence, including evidence
rebutting a prima facie case of obviousness, must be considered when properly
presented. |
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Hearing Components, Inc. v. Shure Inc., 600 F.3d
1357 (Fed. Cir. 2010). |
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. |
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Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d
1310 (Fed. Cir. 2008). |
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. |
Federal Registerにパブリックコメントの投稿方法が掲載されていますので、そちらをご参照の上、USPTOの本件専用のメールアドレス(KSR_Guidance@uspto.gov)までお送りください。
Bilski事件の最高裁判決を受け、米国特許商標庁(USPTO)は2010年7月27日付で特許性に関する新たな審査基準を発表しました。ilski事件の詳細に関しては、過去のニュース(こちら)をご参照ください。
今回発表された審査基準は 「Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos (Interim Bilski Guidance)」 と題され、文字通りBilski事件の判決を基礎として、プロセスクレームの特許性に関する判断基準を説明しています。
このInterim Bilski Guidanceを概説すると、35U.S. C.§101に則り、クレームの対象が抽象的なアイデア(Abstract Idea)となっていないかを判断するためのガイドラインとなります。
具体的には、プロセスクレームが、Bilski事件の連邦巡回控訴裁判所における判決から基準となった (i) "machine-or-transformation"テストに規定される要件を満たす、もしくは、(ii)抽象的なアイデアが実用的に適用されている、のいずれかの要件を満たしていれば特許性があるものと判断されます。
また、Interim
Bilski Guidanceには、特許性の判断に関する参照表が添付されていますが、この参照表では各種要件を以下2項目に分けて明文化しています。
1.Factors Weighing
Toward Eligibility(特許性をありとするための要件)
2.Factors Weighing
Against Eligibility(特許性をなしとするための要件)
さらに、上記2つの要件に加え、注意事項として以下4点が列挙されています。
1.General
Concept(一般概念)に含まれるものの一例
2.「machine」 「transformation」 「article」 「particular」 「extra-solution
activity」 「field-of-use」に関するより具体的な説明は、2009年8月24日付けのガイドライン(Interim Patent
Subject Matter Eligibility Examination Instructions of August 24, 2009(August
2009 Interim Instructions))を参照すること
3.特許性の判断をする場合には、関連要因に重点を置き、クレーム全体をみて判断すること
4.拒絶理由通知に記載をする際の、文章のサンプル
ご存知の通り、2010年4月1日より、欧州特許出願について、分割出願の時期的制限についての制度改正が施行されています。
これまでは親出願が継続中であればいつでも分割出願は可能でしたが、2010年4月1日以降は親出願に対して「最初の審査報告がだされてから24ヶ月以内まで」と制限が加わりした。ただし、基礎となる親出願が審査に係属していることが条件となっていますので注意が必要です。
また、新ルール施行前に審査報告が出されている出願を考慮し、2010年4月1日から6ヶ月間、猶予期間が与えられています。つまり、分割期限の満了日が2010 年4 月1日より前、または2010 年4 月1 日から6 か月以内の場合には、2010年4 月1 日から6 か月間(2010 年10 月1 日まで)は分割出願をすることが可能となっています。
尚、最初の審査報告が出された後に、単一性に関する審査報告をExamining Division(審査部)より受け取った場合には、起算日がセットオフされ、単一性に関する拒絶が起算日となります。
先述の猶予期間満了まで3ヵ月をきっていますので、再度ご自分の欧州出願を見直し、分割出願の期限をおよび必要性を検討することをお勧めいたします。
今回、USPTO(特許庁)の審査官を代表する労働者組合(Patent Office Professional Association : POPA)との協力のもと、USPTOはRCE(継続審査請求)の審査数を減らす事を目的として、RCEに関する「カウント」(成績評価点数システム)およびドケッティングシステムを見直して変更すると発表しました。
これまでのPTOドケットシステムにおいては、RCEは他の継続出願と異なり"Regular Amended docket"システムに従って管理がなされていたため、審査官はRCEが請求されてから2ヵ月以内に再度審査をしなければならなりませんでした。今回の見直によれば、RCEは、"Special New application docket"システムに従って管理がなされるため、分割出願等と同じ扱いとなり、出願日の古いものから処理されることとなります。ただし、許可が示唆されたRCE案件に関しては、今後もすぐに審査を継続できるため、それほど大きな損失はないと思われます。ここで問題になるのが、審査官の「カウント」=成績評価システムです。米国では、審査官の成績を見るにあたり、処理内容によって様々な得点(カウント)が付与されます。これまでのカウントシステムでは、最初に出される拒絶理由通知と、RCE後に出される最初の拒絶理由通知に与えられるポイントが同得点であったことにより、RCEを推奨した後に許可通知を出すことで審査官はポイント稼ぎができる状況にありました。新しいカウントシステムでは、RCE後の拒絶理由通知に与えられるポイントが下がると共に、出願人とのインタビューには時間でのクレジット(1時間のNon-Examining Hour)が与えられます。
要するに、これからは、審査官は出願人とより多くのインタビューを実施し、許可可能なクレームを審査官と出願人が共に協力して見つけ出すことが推奨されることになります。
米国特許庁の発表に興味のある方は、下のリンクをご覧ください。
http://www.uspto.gov/patents/rce_handling_in_new_count_system.doc
オフィスアクションは、出願に何らかの拒絶理由があるときに発せられますが、解消可能な形式的若しくは方式的な拒絶理由はオブジェクション(objection)と呼ばれ、実質的な拒絶理由はリジェクション(rejection)と呼ばれます。また、オフィスアクション中には、登録可能な特許請求の範囲がある場合にはそれも明示されます。
日本の拒絶理由と比較すると、非常に細かく具体的であるため、応答はしやすいと思われます。これは、日本の審査基準に当たるMPEPにて、拒絶の要領が事細かに指定され、それに従っていないと不適法なオフィスアクションと判断されるためです。
オフィスアクションに対しては、日本の拒絶理由通知と同様に、日本の意見書及ぼ補正書に相当するものを提出することにより応答(response)します。応答においては、特許請求の範囲の補正もすることができ、その要件は日本のものと非常に似ています。