出願後の手続
米国弁理士 矢口太郎
パラリーガル 山口美紀
(M)
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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。
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
Information Disclosure Statement (IDS、情報開示義務)は、出願から特許登録まで続きます。能動的に先行技術を調査し続ける必要はありませんが、関連特許出願、特に同じ出願内容の各国出願分に対して拒絶理由通知や調査報告等が出され、そこに引用例が出されている場合には、それらをIDSとして米国特許庁に対して開示する手続きをとる必要があります。
また、許可通知がおりた後、また登録料を納付した後でも、特許登録がなされていない状態であれば情報開示の手続きをとる義務は続いています。
情報開示の義務に関しては、義務を遂行していないことを特許庁が能動的に調べることがなく、また義務の遂行を怠ったがために審査が遅れることや中止されることがないため、手続きをおろそかにする出願人もいます。ただ、この義務が遂行されていないことが発覚した場合には、特許権を行使できなくなるとても危険な義務です。
米国での特許存続期間は、出願から20年です。ただし、1995年6月8日以降、2000年5月29日以前に出願された特許に関しては、出願人にとって不利になる審査の遅滞があった場合、この遅滞分特許期間が延長されます。
また、特許が登録された後の手続としては、登録日から3.5年、7.5年および11.5年目の計3回の特許料の納付があります。該当年の登録月日6ヶ月前に登録料納付期間が始まり、登録月日に納付期間が終了します。6ヵ月の年金納付猶予期間がありますが、猶予期間を利用して年金を納付する場合には、ペナルティーとして印紙代の50%(いわゆる「倍額期間」)が加算されますので注意が必要です。
なお、日本と異なる点として、米国においては、特許の復活がかなり広く認められることが挙げられます。不可抗力な場合だけなく、「故意でない」場合まで含みますからほとんどの場合救済されます。また、復活できる期限もかなり長いということがありますので、年金を納付しなかったとしても諦めるのではなく、米国の場合には何とかなる場合が多いので、復活にトライされることをお勧めします。
このように翻訳文を後出しにすることによって、出願時に係る翻訳費用を後に繰り延べすることがすることが可能になります。
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。