When Motion to amend is filed in IPR, Opponent can cite additional references.

Sadao Kinashi | July 18, 2017

Shinn Fu vs. Tire Hanger (Fed. Cir. 2017)

July 3, 2017

Before Prost, Reyna and Taranto. Opinion by Prost

Summary:

This is an appeal from an inter partes review (IPR) of USP 6,681,897 (“’897 patent”).  The patentee filed a motion to amend.  Petitioner opposed to the motion and presented arguments of unpatentability adding new references.  The Board ignored Petitioner’s argument and granted the patent owner’s motion to amend and held the substitute claims patentable.

CAFC vacated and remanded holding that the Board did not properly consider the petitioner’s arguments in opposition to the Patentee’s motion to amend.

この事件は、米国特許6,681,897の当事者系レビュー(IPR)の決定の不服申立に関する。特許権者はIPRでクレームを補正する申立をした。請求人は先行技術引例を追加して補正クレームは特許性がないと主張した。審判部は、補正に対する請求人の主張を無視し、補正クレームは特許性ありとして補正を認めた。

CAFCは、審判部が、補正の申立に反対する主張を考慮しなかったのは不当であるとして、審決を取消し、補正に反対する主張の審理のため差戻した。


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5000 PLUS PAGE PROVISIONAL APPLICATION DOES NOT ENABLE CLAIMS IN ISSUED PATENT

Stephen G. Adrian | July 7, 2017

Storer v. Clark

June 21, 2017

Before Prost, Newman and Dyk.  Opinion by Newman.

Summary:

Although the first-to-file provisions of the Leahy-Smith America Invents Act (AIA) went into effect March 16, 2013, interference proceedings are still with us, as highlighted by this decision from the Court of Appeals for the Federal Circuit (CAFC). An interference proceeding was declared December 3, 2013[1], between Storer’s U.S. Patent No. 7,608,600 (application filed June 27, 2003) and Clark’s pending application No. 11/854,218. The interfering claims are directed to treatment of hepatitis C using modified nucleoside compounds. Storer was initially designated senior party based upon its earlier provisional application No. 60/392,350, filed June 28, 2002. Clark claimed priority based on a provisional application filed May 30, 2003. Clark moved to deny Storer the priority date of the provisional application arguing that the provisional application did not enable a five-membered ring having a fluorine substituent in the 2’ (down) position:

 

 

 

 

 

 

 

The Patent Trial and Appeal Board (PTAB) held that Storer’s provisional application was not enabling for the count in the interference, and entered judgment granting priority to Clark.

The parties agreed that the only question at issue is whether Storer’s provisional application enables compounds having F in the 2’ (down) position (35 U.S.C. §112, first paragraph). The Board held that the provisional application, taken together with the prior art, did not enable the specific compounds having the identified structure.

“The enablement requirement is met where one skilled in the art, having read the specification, could practice the invention without ‘undue experimentation.’” Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269, 1288 (Fed. Cir. 2012) (quoting ALZA Corp. v. Andrx Pharm., LLC, 603 F.3d 935, 940 (Fed. Cir. 2010)). Thus, an analysis was made as to whether undue experimentation was required. As summarized in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), relevant factors to consider with respect to undue experimentation may “include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”

Storer did not dispute the Board’s conclusions of the Wands’ factors 3, 4, 5, 6 and 8, but argued that these factors are not dispositive of enablement. The Board found with respect to 3-6 and 8:

(3) The provisional application contains no specific examples of synthesis of compounds having the fluoro substituent in the 2’ (down) position.

(4) At the time of the provisional application, although organic fluoridation mechanisms were generally known, a 2’-fluoro-2’-methyl nucleoside with the fluoro substituent in the down position had not yet been synthesized.

(5) although organic fluoridation techniques were well-known in the art at the time the S1 application (Storer’s provisional application) was filed, fluoridation of tertiary alcohols to produce a 2ˊ “down” tertiary fluorine was not taught or suggested by the prior art.

(6) The level of skill in the art was highly sophisticated: a person possessing the ordinary level of skill in this art, as of the time of invention, would hold a doctoral degree in the field of organic, synthetic, or medicinal chemistry with at least a year’s experience in the field of nucleoside synthesis or relevant drug discovery.

(8) Neither party argued the breadth of the claims.

Thus, a closer examination of the Wands’ factors 1, 2 and 7 is made ((1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; and (7) the predictability or unpredictability of the art).

Although not stated in the decision, the provisional application was over 5000 pages, listing many specific compounds. Storer argued that the provisional application “performed the substantial step of disclosing the precise chemical structure of the target compound.” However, the pages of the specification highlighted by Storer only provide generic formulas which encompass the “target compounds”. Storer further argued that the prior art (Matsuda Compound 17) is a “precursor compound that is only one step away from the target compound.”

 

 

 

 

 

 

 

 

 

This compound contains a methyl group instead of fluoro, which Storer agued would be readily convertible into the target compound by known methods to produce the desired stereochemistry. The Matsuda Compound 17, however, is not disclosed in the provisional application.

Storer attempted to rely upon three reaction schemes disclosed in the provisional application as a path that would lead to the claimed compounds. These reaction schemes, however, showed products with opposite stereochemistry. In addition, it was found that the art was highly unpredictable, which seemed to weigh heavily against Storer’s argument. Evidence had been presented supporting the unpredictability of synthesizing the target compound. Although it was recognized that undue experimentation depends on the subject matter and the skill in the art, it was found that a high amount of experimentation and skill was required.

On review, the CAFC concludes “that substantial evidence supports the Board’s findings that the synthetic schemes in Storer’s provisional application do not teach or suggest conversion of any precursor into the 2´F (down) structure, and that the Matsuda synthesis of a corresponding 2´- methyl (down), 2´-hydroxyl (up) structure does not enable a person of ordinary skill to produce the target compounds without undue experimentation.”

As concluded by the CAFC:

We conclude that substantial evidence supports the Board’s finding that “a high amount of experimentation is necessary to synthesize” the target compound. The record before the Board showed sufficient variability and unpredictability to support the Board’s conclusion that Storer’s provisional application did not enable the interference subject matter. The Board’s decision is affirmed.

Take-Away:

Although an extensive disclosure in a provisional application may be sufficient to support a relatively broad claim scope, such disclosure may not be considered enabling for specific compounds (species) within the broad claim scope, particularly in an unpredictable art. As stated by Board, for new chemical compounds the specification must provide sufficient guidance that undue experimentation is not required to obtain the new compounds.

[1]Storer initially filed in the District of Delaware seeking review under 35 U.S.C. §146 (Idenix Pharmaceuticals, LLC v. Gilead Pharmasset LLC. This case was dismissed based on Biogen MA, Inc. v. Japanese Foundation for Cancer Research, 785 F.3d 648 (Fed. Cir. 2016), ruling that the AIA eliminated the option of district court review under §146 for interferences declared after September 15, 2012.

 

Full Opinion

 

 

 

 

 

 

 

 

 

 

Statements made in IPR proceeding can be relied on to support a finding of prosecution disclaimer during claim construction

Shan Gong | July 5, 2017

Aylus Networks, Inc., v. Apple Inc.

May 11, 2017

Before Moore, Linn, and Stoll.  Opinion by Stoll.

Summary

Patent owner Aylus Networks, Inc. sued Apple Inc. in district court for infringement of the U.S. Patent No. RE 44,412 (“the ‘412 patent”). Apple filed two separate IPRs challenging validity of all the claims. PTAB denied to institute claim 2 based on Aylus’s explanation of a limitation to claim 2. During claim construction in district court, this same explanation is relied on to support a finding of prosecution disclaimer. CAFC affirmed the district court’s finding of prosecution history disclaimer. CAFC also stated that prosecution disclaimer applies whether a statement is made before or after instituting an IPR.


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Alice: ‘This is impossible’ (Alice in Wonderland 2010): Alice (Corp. Pty. Ltd. v. CLS Bank Int’l,), aid’s in striking yet another blow against the pursuit of diagnostic test method

Adele Critchley | June 26, 2017

Cleveland Clinic Foundation v. True Health Diagnostics LLC

June 16, 2017

Before Lourie, Reyna and Wallach.  Opinion by Reyna.

Summary:

The CAFC affirmed the invalidly of method claims in three diagnostic test patents held by Cleveland Clinic Foundation (hereon – Cleveland Clinic), and further affirmed that True Health Diagnostics LLC (hereon – True Health) was not liable for contributory or induced infringement of a fourth patent directed to methods of treating patients diagnosed by the diagnostic tests.

This CAFC decision strikes another blow against the patent eligibility of diagnostic methods, while further highlighting the difficulty of enforcing method treatments based on such diagnostic tests (i.e., personalized medicine).


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