When is Evidence of Written Description Too Late?

Scott Daniels | October 24, 2017

Amgen v. Sanofi

October 5, 2017

Before Prost, Taranto and Hughes. Opinion by Judge Prost.

Procedural History:

The two patents-in-suit disclose and claim a set of antibodies.  The following claim is representative:

An isolated monoclonal antibody,

 wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and

 wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R.

The technical background of the invention involves statins that are administered to patients to reduce high levels of LDL-C in the blood.  When these statins do not work, doctors sometimes administer PCSF9 inhibitor as well – PCSK9 being a naturally occurring protein that binds to and destroys liver cell LDL-receptors that take LDL-C from the blood.

The claim recites a genus of antibodies that bind to PCSK9 at the recited residue sites, thereby preventing PCSK9 from interfering with LDL-C removal from the blood.

The specification, common to both patents, discloses “85 antibodies that blocked interaction between the PCSK9 . . . and the LDLR [at] greater than 90%,”  It also discloses the three-dimensional structures, obtained via x-ray crystallography, of two antibodies known to bind to residues recited in the claims—21B12 (Repatha) and 31H4.

Appellant/Defendant Sanofi markets an antibody named Praluent® alirocumab.  Appellee/Patentee sued Sanofi for patent infringement.  Sanofi replied, inter alia, that the claims did not comply with the written description and enablement requirements.

In a jury trial, the judge excluded from the evidentiary record all post-priority-date information that Sanofi proffered to show that the written description and enablement requirements were not met.  Specifically, Sanofi’s proffered evidence that included its own later-developed Praluent product that was developed after the priority date of Amgen’s patents.

Ultimately, the jury issued a verdict that the patents were valid and infringed.

The CAFC reversed the trial judge’s exclusionary ruling and vacated the jury’s verdict.  It first set forth the legal background, specifically, that a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date” and that to provide this “precise definition” for a claim to a genus, a patentee must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” (Emphasis added).

Here, Sanofi’s evidence regarding Praluent was relevant to the material issue of whether the two patents disclosed a representative number of species within the claimed genus.  The CAFC therefore held that the trial judge erred in excluding Sanofi’s evidence and ordered a new trial on written description.  It also ordered a new trial on enablement for the same reasons.

The CAFC summarized the legal basis for its holding: evidence that explains the state of the art after the priority date is not relevant to written description. On the other hand, where a patent claims a genus, it must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Accordingly, evidence showing that a claimed genus does not disclose a representative number of species may include evidence of species that fall within the claimed genus but are not disclosed by the patent, and evidence of such species is likely to postdate the priority date.

Take Away

The lesson is that the purpose for which post-priority date evidence is proffered determines whether it is admissible.

Full Opinion

 

The Federal Circuit finally provided guidance on patent venue rules and struck down Judge Gilstrap’s patent venue rules

Sung-Hoon Kim | October 23, 2017

In Re: Cray Inc.

September 21, 2017

Before Lourie, Reyna, and Stoll.  Opinion by Lourie.

Summary:

Cray petitioned for a writ of mandamus directing reversal of the order of the U.S. District Court for the Eastern District of Texas denying its motion to transfer venue and directing the district court to transfer the case to the Western District of Wisconsin.  The Federal Circuit found that the EX of TX misinterpreted the scope and effect of the precedent in determining that Cray maintained “a regular and established place of business” in the ED of TX within the meaning of §1400(b).  Therefore, the Federal Circuit held that the ED of TX’s decision to refuse transfer of the case was an abuse of discretion and granted Cray’s petition.


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The Board Stretches the Broadest Reasonable Interpretation Standard to Broadest Possible Interpretation

Bill Schertler | October 20, 2017

In re Smith International, Inc.

September 26, 2017

Before Lourie, Reyna, Hughes.  Opinion by Lourie.

Procedural History:

Smith International (“Smith”) owns U.S. Patent No. 6,732,817 (the ‘817 patent) directed to a downhole drilling tool for oil and gas operations.  In 2012, Smith’s corporate parents, Schlumberger Holdings Corp. and Schlumberger N.V., sued Baker Hughes Inc. (“Baker Hughes”) in the United States District Court for the Southern District of Texas for, inter alia, infringement of the ’817 patent.  Baker Hughes requested ex parte reexamination of claims 28–37, 39–46, 49, and 50 of the ’817 patent.  The PTO granted the request for ex parte reexamination, which is the subject of appeal in this case.

In the reexamination, the Examiner finally rejected claims 28–36, 39, 40, 42, 79–80, 93–98, and 100 as anticipated by International Publication No. WO 00/31371 (“Eddison”).  The Examiner rejected claims 43–46, and 49 as obvious over Eddison in view of U.S. Patent 6,059,051 (“Jewkes”), and claims 28, 40, 41, 43, 50, 80, 81, 93, and 99 as obvious over Eddison, European Publication No. EP 0 246 789 (“Wardley”), and Jewkes.  Smith appealed to the Patent Trial and Appeal Board (“Board”), and the Board affirmed all of the examiner’s rejections.  The Court of Appeal for the Federal Circuit (“CAFC”) reversed the Board.

Details:

This case primarily concerns what the word “body” means in the context of the ’817 patent.

Representative claim 28 is set forth below.

28.  An expandable downhole tool for use in a drilling assembly positioned within a wellbore having an original diameter borehole and an enlarged diameter borehole, comprising:

 a body; and

at least one non-pivotable, moveable arm having at least one borehole engaging pad adapted to accommodate cutting structures or wear structures or a combination thereof and having angled surfaces that engage said body to prevent said arm from vibrating in said second position;

wherein said at least one arm is moveable between a first position defining a collapsed diameter, and a second position defining an expanded diameter approximately equal to said enlarged diameter borehole.

Fig. 4 of the ‘817 patent is reproduced below to show, inter alia, the “body” (tool body 510) and the “moveable arm” (moveable tool arm 520).

 

 

 

 

 

 

 

 

 

Reexamination

During reexamination, using the broadest reasonable interpretation standard, the Examiner construed the term “body” broadly to correspond to the “body” 18, “mandrel” 16 and “cam sleeve” 28 of Eddison.  Eddison discloses a drilling tool having a “mandrel 16” that “extends through the body 18” and “provides mounting for a cam sleeve 28,” which “cooperates with the extendable members 30 in the form of cutters 30 mounted in respective body ports 32.”  See Fig. 1 of Eddison reproduced below.

 

 

 

 

 

 

 

 

 

Relying on the broad construction of “body”, the Examiner found that Eddison teaches “at least one non-pivotable, moveable arm…having angled surfaces that engage said body” in claim 28 and corresponding elements in other independent claims.

The Board

On appeal to the Board, the Board affirmed the Examiner’s interpretation of the word “body” as a broad term that may encompass other components such as “mandrel” and “cam sleeve”.  The Board reasoned that the term “body” is a generic term that by itself provides no structural specificity.  The Board also reasoned that although “the specification describes the body as a discrete element separate from other elements,” the specification neither defines the term “body” nor precludes the Examiner’s broad reading of it.

The Board rejected Smith’s argument that one of ordinary skill in the art would understand the term “body” as a distinct element from other components.  Based on the Board’s interpretation of the term “body,” the board affirmed the Examiner’s anticipation and obviousness rejections based on Eddison.

CAFC

On appeal to the CAFC, Smith challenged the Board’s construction of the term “body” and the anticipation and obviousness determinations.  Smith argued that the Board’s interpretation of the term “body” was unreasonable and inconsistent with the specification.  More specifically, Smith argued that the Board’s interpretation of “body” as a generic term encompassing the drilling tool’s internal components was unreasonable because the specification consistently refers to and depicts the body of the drilling tool as a component distinct from other separately identified components, such as the “mandrel” or “piston” that reside inside the drilling tool.  In light of the consistent description of the body, Smith urged that the term “body” should be interpreted as an “outer housing.”

The CAFC, using the expressions “strained interpretation” and “arbitrary inclusion of elements” to describe the Board’s construction, concluded that the Board’s construction of “body” was unreasonably broad.

The CAFC reasoned that the ‘817 specification does not use the term as a generic body.  Instead, the ’817 patent separately identifies and describes various components of its drilling tool, such as the “body,” “moveable arms,” “mandrel,” “piston,” and “drive ring,” which do not support the Board’s broad reading of the claim term “body.”  In this connection, the CAFC stated “There is no dispute that the ’817 patent specification consistently describes and refers to the body as a component distinct from others, such as the mandrel, piston, and drive ring.  Therefore, the Board’s reasoning that because the specification does not ‘in and of itself proscribe the Examiner’s construction,’ the Examiner’s interpretation was reasonable, was erroneous.”

The CAFC addressed the Board’s reasoning in support of adopting the broad interpretation that “the patentee here did not act as a lexicographer, and that the specification neither defines nor precludes the examiner’s reading of the term ‘body’.”  Using this reasoning, the Board found that nothing in the specification would disallow the examiner’s interpretation, rendering it “reasonable.”  However, the CAFC responded “following such logic, any description short of an express definition or disclaimer in the specification would result in an adoption of a broadest possible interpretation of a claim term, irrespective of repeated and consistent descriptions in the specification that indicate otherwise. That is not properly giving the claim term its broadest reasonable interpretation in light of the specification.” [Emphasis added.]

Finally, the CAFC stated, “The correct inquiry in giving a claim term its broadest reasonable interpretation in light of the specification is not whether the specification proscribes or precludes some broad reading of the claim term adopted by the examiner. And it is not simply an interpretation that is not inconsistent with the specification. It is an interpretation that corresponds with what and how the inventor describes his invention in the specification, i.e., an interpretation that is ‘consistent with the specification.’”

Full Opinion

Obviousness Found Even When the Burden to Prove Inherency Remains on Examiner

Yoshiya Nakamura | October 18, 2017

SOUTHWIRE COMPANY v. CERRO WIRE LLC

September 8, 2017

Before Lourie, Moore and Hughes.  Opinion by Lourie.

Summary

Southwire Co. (the patent owner) owns No. 7,557,301 (the ’301 patent). An inter parte reexamination is initiated by a third party requestor, Cerro wire LLC (the requester).  All the claims of the ’301 patent are found obvious over prior art references under 35 U.S.C. § 103.  It is decided in the reexamination that one of the combinations of cited references inherently discloses a claimed parameter at issue.  CAFC affirms PTAB’s conclusion that the claims are unpatentable as obvious, while rejecting part of the reasoning that the claimed parameter is inherently disclosed in the cited references.

Japanese Summary

本件特許はケーブルのジャケットの材料に潤滑剤を含ませて製造することで、完成したケーブル表面のフリクションを減らし、ケーブルをビル内等に設置するのに必要な引っ張り力を減少させることができるケーブルの製造方法に関する。当事者系再審査請求において、特許クレームは先行技術文献から自明であると拒絶され、審判部もその結論を支持した。特許権者は、主要引用例(Summers)にクレームの数値限定(ケーブルを設置するために引っ張る力を少なくとも30%減少させる特性)が内在的に(inherently)開示されているから自明であるとした特許庁の認定を不服として、巡回区控訴裁判所(CAFC)に提訴した。

CAFCは、前記引用例はケーブル表面のフリクションや設置のための力を測定しておらず、開示されている製法が必然的に(necessarily)クレームの数値限定を達成できること示す事実・証拠がないため、クレームの数値限定が内在的に開示されているという特許庁の認定は間違いであると指摘し、内在的開示の存在を否定した。内在的な開示は認められないが、その一方で主要引用例には製造時に潤滑剤を混入してフリクションの小さいケーブルを製造し得るプロセス自体は教示されているので、先行技術を克服するためにはクレーム限定が予期せぬ結果であることを示さなければならないとし、本件では予期せぬ結果の証明がないことを理由に発明が自明であるとの結論を支持した。

特許クレームは先行技術の製法とほぼ同一に見えるが、特許権者が定義したパラメータ(ケーブルを設置するために必要な力の範囲)をクレームすることで特許になった製法である。このようなパラメータ特許でも、先行技術の製法で「必ず」同じ結果が得られることを特許庁が示さなければ内在的な開示を認定してはいけないことが示唆された。しかし、他方で、先行技術と製法が実質的に同じである点で自明性が仮定されるので、出願人はそのパラメータ限定が予期せぬ効果であること示す証明責任があることが示唆された。



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