Obviousness : CAFC Alert

Not All Secondary Considerations are Probative of Nonobviousness

Lee Wright | July 23, 2014

Galderma Labs v. Tolmar, Inc.

December 11, 2013

Before NEWMAN, BRYSON, and PROST, Circuit Judges. Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge NEWMAN.

SUMMARY

This Hatch-Waxman case is based on Tolmar’s filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic drug (Differin® Gel,0.3%), which is a topical medication containing 0.3% by weight adapalene approved for the treatment of acne.


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Weak Prima Facie Case Obviousness vs. Strong Evidence of Non-Obviousness

Yoshiya Nakamura | January 22, 2014

Institute Pasteur v. Focarino (Fed. Cir. 2013)
(2012-1486)

Decided December 30, 2013

Before NEWMAN, CLEVENGER, and TARANTO, Circuit Judges. TARANTO, Circuit Judge.

Key Words: non-obviousness, biotechnology, enzyme, reasonable expectation of success

Summary:

Institute Pasteur (Pasteur) owned patents claiming inventions related to a group of enzymes, i.e., Group I intron-encoded (GIIE) endonucleases.  The enzymes are useful as laboratory tools to cut a DNA sequence at a particular site of the sequence in vitro or in situ.  In reexamination of the patents, the Board of Appeals rejected the claims as being obvious over cited references.  Pasteur appealed to the CAFC.  The CAFC vacated the Board decision and remanded for consideration of what would constitute motivation for one skilled in the art to pursue the claimed invention because the Board misread the teachings in prior art and failed to weigh properly substantive evidence of non-obviousness.

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Patent Infringement Litigation as a Double-Edged Sword: Invalidated Patents and Inequitable Conduct

John M. Wang | December 6, 2013

The Ohio Willow Wood Company (OWW) v. ALPS South LLC. (Alps)

Decided November 15, 2013

Before Dyk (Circuit Judge), Bryson (Circuit Judge) and Reyna (Circuit Judge).  Opinion by Reyna.

Keywords: collateral estoppel, obviousness, inequitable conduct, reexamination, and rule of reason.

Summary:

OWW initiated a suit against Alps for patent infringement.  After a long legal battle including two ex parte reexaminations, two District Court proceedings, and two CAFC appeals, OWW lost two patents and was charged with inequitable conduct.

Details:

OWW is the owner of US Patent No. 5,830,237 (the ‘237 patent), entitled “Gel and Cushioning Devices,” filed on March 5, 1996.  The ‘237 patent disclosed cushioning devices designed to cover the residual stumps of amputated limbs, acting as a shape-conforming buffer, as illustrated below, to make the use of attached prostheses more comfortable.  The primary invention was a cushion liner comprising a fabric covering in the shape of a tube sock coated on only one side with mineral oil-based polymeric gels.

fig.1

On December 27, 2004, OWW filed its complaint against Alps for infringement of the ‘237 patent.  After the District Court issued its Claim Construction order in the proceedings, Alps filed its first request for an ex parte reexamination of the ‘237 patent.  The District Court stayed the litigation for the duration of reexamination proceedings, pending resolution of the validity of the disputed patent.
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“Ordinary Designer” Standard Should Be Used in Design Patent Obviousness Analysis

Kumiko Ide | October 24, 2013

High Point Design LLC, et al. v. Buyer’s Direct, Inc.

September 11, 2013

Panel: O’Malley, Schall, and Wallach. Opinion by Schall

Summary 

This case addresses obviousness and functionality analysis for design patents.  The CAFC stated that the obviousness of a design patent must be analyzed from the perception of a designer of ordinary skill in the field to which the design pertains. With regards to functionality, a design that can perform functions can be protected under design patent so long as the claimed design is “primarily ornamental” and not “primarily functional.”

意匠特許の自明性を判断する場合には、その意匠の分野の当業者の観点から分析を行うことが必要とされる。また、機能的な要素を有する意匠でも、その意匠が主として機能的ではなく、主として装飾的であれば、意匠特許の対象となる。


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CAFC Reminds the Patent Office to Play Fair When Issuing New Grounds of Rejection and Evaluating Objective Evidence of Non-Obviousness

Cindy Chen | October 3, 2013

Rambus Inc. v. Rea

September 24, 2013

Panel of Moore, Linn, and O’Malley, Opinion by Moore

Summary

The Court of Appeals for the Federal Circuit in Rambus Inc. v. Rea reminds Examiners and the Board of Patent Appeals and Interferences (now the Patent Trial and Appeal Board) that procedural checks remain in place for issuing new grounds of rejection. Examiners and the Board cannot bury a new ground of rejection in a decision, without ensuring that a patent applicant has had a fair opportunity to respond to the rejection. Indeed, whether the applicant has had a fair opportunity to react to the thrust of the rejection is reiterated as the ultimate determination of whether a rejection is considered “new”.

In line with the Federal Circuit’s recent decision in Leo Pharmaceutical Products v. Rea, Rambus is also a reminder that objective evidence of non-obviousness must be given due consideration and weight. Examiners and the Board cannot undercut an applicant’s objective evidence of non-obviousness through an overly stringent interpretation of the nexus and “commensurate in scope” requirements.


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CAFC Provides Potent Remedy For Common PTO Obviousness Rejections

Stephen G. Adrian | September 27, 2013

Leo Pharmaceutical Products v. Rea

August 12, 2013

Panel of Rader, O’Malley and Reyna; opinion by Rader

The Court of Appeals for the Federal Circuit recently provided excellent guidance for responding to obviousness rejections which at first blush seem strong. In Leo Pharmaceutical Products Ltd. v. Rea, decided August 12, 2013, it reversed the Board of Patent Appeals and Interferences because the Board incorrectly weighed the objective indicia of non-obviousness.

The appeal arises from an inter partes reexamination of U.S. Patent No. 6,753,013 (the ‘013 patent). Claim 1 is directed to a pharmaceutical composition for dermal use which included a vitamin D analog, a corticosteroid and a solvent. During the inter partes reexamination proceeding, claim 1 had been amended to include the phrase “wherein said pharmaceutical composition is storage stable and non-aqueous,” which proved to be pivotal in securing the favorable decision for Leo Pharmaceutical Products, Ltd.


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Did the CAFC Extrapolate From the Teachings of the References to Reach the Conclusion of Obviousness?

Bill Schertler | August 12, 2013

In re Adler

July 18, 2013

Panel:  Prost, Reyna and Wallach.  Opinion by Wallach

Summary

The Examiner rejected all of the pending claims under 35 U.S.C. §103 as obvious over several prior art references, including International Patent Publication WO 00/22975 (“Meron”) in view of Masaru Hirata et al., Study of New Prognostic Factors of Esophageal Variceal Rupture By Use of Image Processing With a Video Endoscope, 116 Surgery 8–16 (1994) (“Hirata”).

The Board of Patent Appeals and Interferences (“the Board”) affirmed the Examiner’s rejection of all pending claims of U.S. Patent Application No. 10/097,096 (the ‘096 application) under 35 U.S.C. §103 as being obvious over a combination of prior art references.  Adler appealed the Board’s decision to the Court of Appeals for the Federal Circuit (CAFC).  The CAFC affirms holding that the Board did not err in rejecting the pending claims as obvious and did not rely on new grounds for rejection.


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Unexpected result for combination therapy using two known drugs

Yoshiya Nakamura | July 24, 2013

Novo Nordisk A/S v. Caraco Phamaceutical Laboratories, Ltd.

June 18, 2013

Panel:  Newman, Dyk and Prost.  Opinion by Prost.  Dissent by Newman.

Summary:

A patent claims a combination therapy using two drugs.  The patent was issued by overcoming prior art as an examiner recognized an unexpected result proved by an inventor’s declaration.  In the district court, defendant presented new evidence challenging the validity of the patent.   The evidence showed that one of the claimed drugs was well known to be used in the therapy, and another drug having similar mechanism as the other was also well known to be used in such combination therapy.  Relying on the evidence, the district court hold that the patent was obvious because the evidence created a strong prima facie case of obviousness, and it was so strong that the patentee’s evidence showing certain superior effects did not overcome the prima facie obviousness. The majority agreed with the district court holding.  Judge Newman dissented.

地裁は、2つの公知の薬物(repaglinideとmetformin)の併用による糖尿病治療方法の特許に関して予期せぬ効果は立証されなかったため無効であると判断した。連邦巡回区控訴裁判所(CAFC)はその特許無効判決を支持した。Metforminは同治療用として周知であり、repaglinideはmetforminとは異なる経路に作用するものとして糖尿病治療に利用されていた。先ず特許庁では、その併用は加算的な効果しかないとして審査官に拒絶されたが、出願人が追加実験データを提出することにより相乗効果が認められ特許になった。その後、侵害被疑者は地裁で新たな証拠を出した。それによるとrepaglinideと同じクラス(sulfonylureas)に属する同様の機能を有する化合物をmetforminと併用する療法が知られていた。他方、特許権者は、repaglinideはその文献に記載のsulfonylurea化合物とは異なること、特にmetforminとrepaglinideの併用はmetforminの単独使用と比較して空腹時血漿グルコースレベルを8倍も改善するという証拠を出した。しかしながら,地裁は侵害被疑者の証拠を採用し、特許無効の判決を出した。CAFCは、repaglinideとsulfonylurea類の併用が周知であり、ある種の相乗効果も報告されている点を強調し、地裁に同意し、特許権者の主張を退けた。特許権者の証拠によるとrepaglinide単独の特性から見て予想外な併用効果があることも示唆されるがCAFCは類似の併用療法が周知であるという全体的な方向性を見て、特許権者の具体的な反論を認めなかった。本件は、公知の薬物の併用はそれと類似の併用例が知られていると強い自明性の仮定が働き、特許権者はそれを克服するために相当に高いレベルの反証が要求されることを示す判決である。本件では、クレーム治療方法の商業的成功の証拠は不十分であるとして認められなかった。

なお、判事の一人(Newman)は、反対意見を述べている。化学的実験というものはある程度の予測、希望を持ってなされるものであり、そのような状況があるということで直ちに「自明な試み」として特許しないのはいかにも不合理であるといった趣旨である。特にrepaglinide自体は先行技術の化合物とは異なるにもかかわらず、repaglinideによる併用効果の発見は特許権者が公知の併用療法をさらに追求した結果にすぎないと示唆したことは、後知恵による判断であると非難した。


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CAFC clarifies the presumption that prior art is enabled after In re Antor Media Corp (Fed. Cir. 2012)

Michael Caridi | April 10, 2013

In re Steve Morsa

April 5, 2013

Panel:  Rader, Lourie and O’Malley.  Opinion by O’Malley.

Summary

The Board of Patent Appeals and Interferences (“Board”) had affirmed an Examiner’s finding that a short press release, relied on for an anticipation rejection, was enabling.  In making its decision, the Board had held that arguments alone by the applicant were insufficient to rebut the presumption that a reference was enabling.  The CAFC found that the Board and the examiner had failed to engage in a proper enablement analysis of the reference and vacated the anticipation finding.


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Board Should Consider Appellee’s Grounds For Affirming Rejection Presented To Examiner During Reexamination, Even If Grounds Had Not Been Raised On Appeal

Bill Schertler | February 6, 2013

Rexnord Industries v. Kappos

January 23, 2013

Panel:  Newman, Lourie, Prost.  Opinion by Newman.

Summary:

In 2003 Habasit filed an infringement suit against Rexnord in the United States District Court for the District of Delaware for infringement of its U.S. Patent No. 6,523,680 (the ’680 patent).  Rexnord then requested inter partes reexamination of the ’680 patent, and the district court stayed the infringement suit pending completion of reexamination.

On reexamination, the examiner held all of the claims in the ’680 patent unpatentable for anticipation and obviousness.  Habasit appealed the examiner’s decision to the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board).  On appeal, the Board reversed the examiner’s decision and held the claims patentable.

Rexnord appealed to the CAFC.  The CAFC affirmed that the claims are not anticipated, and reversed the Board’s determination that the claimed invention is not obvious in view of certain prior art.


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