written description : CAFC Alert

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

 

A diagnostic method that raises, not patent-eligibility, but written description issues.

Nicolas Seckel | July 24, 2017

Stanford Univ. v. The Chinese Univ. of Hong Kong (Precedential)

June 27, 2017

Before O’Malley, Reyna, and Chen.  Opinion by O’Malley.

Summary:

In interferences involving a patent by Stanford and applications by the Chinese University of Hong Kong, the USPTO found the Stanford patent’s claims unpatentable as lacking written description. The Federal Circuit vacated and remanded. The USPTO was faulted for relying on post-filing date information as evidence of what the person of the art knew at the filing date.


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Of Closed Pods, Open Cartridges, Single-Brew Coffee Machines, and Descriptive Issues

Nicolas Seckel | June 5, 2017

Rivera v. ITC (Precedential)

May 23, 2017

Before Reyna, Linn and Chen. Opinion by Linn.

Summary:

The Federal Circuit affirmed an ITC decision that the asserted patent claims are invalid for lack of written description. The patent application as filed described only a coffee machine with a cartridge adapter configured to receive a closed “pod”, not a cartridge adapter with an open filter for ground coffee. Thus, the written description did not show possession by the inventors of a genus encompassing the open-filter cartridge adapters at the initial filing date.


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Priority document can inherently support subject matter first disclosed in later application

Ryan Chirnomas | October 27, 2016

Yeda Research and Development Co. Ltd. v. Abbott GmbH & Co. KG

September 20, 2016

Before Reyna, Wallach and Hughes.  Opinion by Reyna

Summary:

In a case arising out of an interference, validity of the patent in question turned on the question of whether structural features of a protein, which were newly added in the U.S. application, were inherently supported by the priority document.  Here, it was found that the priority document did inherently support the claimed protein, and any structural features thereof, even if it did not disclose the specific claimed structural features.   This is because there was only one protein that could possibly be described by the priority document.

Details:

Abbott is the owner of U.S. Patent No. 5,344,915, which claims priority to German applications P39 15 072 and P29 22 089.   The ‘915 patent discloses a protein called TBP-II, which neutralizes TNF-α, a key protein in immunological diseases.  The key claim is as follows:

1.  A purified and isolated TNFα-binding protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence

Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu

where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences Ala Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val Ala Phe.

Meanwhile, the German priority documents to which the ‘915 patent claims priority do not disclose the complete N-terminus sequence.  These Germans priority documents disclosed a partial N-terminus sequence, as well as how the protein is obtained from its biological source, and several physical properties of the protein.

This case arises out of an interference between Abbott’s ‘915 patent and Yeda’s application in 1996.   In 2000, the Board assigned Abbott the filing date of the ‘915 patent, not the date of the German priority applications.  The Board concluded that the patent was invalidated by an intervening prior art reference (Engelmann).  Engelmann disclosed the TBP-II protein and distinguished it from a similar protein, TBP-I.  In 2008, Abbott appealed to district court, which indicated that one of the German priority document inherently discloses the TBP-II protein, and sufficiently supports the ‘915 patent.  In 2010, the Board held that the other German priority document sufficiently discloses the TBP-II protein.  Yeda then appealed to district court, which agreed with the Board, and then appealed to the CAFC.

Since Engelmann would be invalidating prior art, the question of validity of the ‘915 patent turns on whether the German priority documents provide written description support.  Yeda first argued that the Board applied the wrong standard.  Specifically, Yeda argued that for the priority document to support the ‘915 claims, the skilled artisan would have to understand that the partial sequence of the priority document includes the amino acids recited in the ‘915 claim.  On the other hand, Abbott argued that the priority document only needs to sufficiently describe the TBP-II protein itself, and the partial sequence disclosure can be coupled with other characteristics.

The CAFC agreed with Abbott and held that the German priority document inherently supports the ‘915 claims. Citing to Kennecott v. Kyocera, 835 F.2d 1419 (Fed. Cir. 1987), the CAFC indicated that when a “specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as an adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.”   It was not disputed that TBP-II is the only protein with the partial sequence and characteristics described in the priority document.  The CAFC distinguished over two cases cited by Yeda (Hyatt v. Boone, 146 F.3d 1348 (Fed. Cir. 1998) and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)), indicating that unlike in those cases, here, it is undisputed that the invention of the earlier application is exactly the same as the invention of the later patent.  Thus, the priority document sufficiently supports the claims reciting the full N-terminal sequence.

Yeda then argued that the prosecution history precludes reliance on inherent disclosure.  Specifically, Yeda argued that in “the context of priority determinations, the allegedly inherent limitation cannot be material to the patentability of the invention,” relying on Hitzeman v. Rutter, 243 F.3d 1345 (Fed. Cir. 2011).  Yeda argued that since Abbott relied on the amino acids in question to distinguish over Engelmann, they are material to patentability.  In prosecution, the Examiner relied on cited art showing a protein with the same source, weight and function as that claimed.  In response, Abbott pointed to Engelmann to show that TBP-I and TBP-II are different.  Abbott also relied on Engelmann to show that TBP-II has five different amino acids than TBP-I, and that these were included in the claimed sequence.   However, three out of the five TBP-II-unique amino acids disclosed in Engelmann were in fact also disclosed in the priority document.  Thus, the sequence of the priority document alone was sufficient to distinguish over the art on its own.  Therefore, Yeda’s argument fails.

Lastly, Yeda argued that the district court was incorrect in holding that the Board’s decision was supported by substantial evidence.  However, the CAFC again reiterated that the priority document disclosed nine of the 15 amino acids of the claimed N-terminus sequence and various biological characteristics.   Furthermore, it was undisputed that no other known protein besides TBP-II has this structure and characteristics.  Thus, the CAFC concluded that the Board’s decision was supported by substantial evidence.

Take away

In many cases, adding a new disclosure to a US application, beyond what is disclosed in a priority application, can result in a breaking of the chain of priority.  But here, because the priority document inherently disclosed the subject matter first disclosed in the US application—and only that subject matter—the claims had written description support as of the priority date.  However, the outcome would have likely been different if the description of the protein in the priority document was later found to correspond multiple proteins, such as stereoisomers having different functions.

Abbott was saved by the fact that they disclosed not only the partial sequence of the protein, but also how it is obtained from its biological source, and several physical properties of the protein.  Thus, in emerging technologies, it is best to try to claim the subject matter as completely as possible to insulate the applicant from written description problems in the future, and to provide the flexibility to claim the subject matter in terms newly added in a later application.

Full Opinion

A Distinction Without A Difference

Adele Critchley | March 21, 2016

Ulf Bamberg, Peter Kummer, Ilona Stiburek v. Jodi A. Dalvey, Nabil F. Nasser

March 9, 2016

Before Moore, Hughes and Stoll.  Opinion by Hughes.

Summary:

The CAFC upheld the Board’s decision that the Bamberg claims were correctly interpreted in light of the Dalvey patents from which they were copied, and functional limitations were not improperly imported.

The CAFC upheld that, in light of the claim interpretation, the Bamberg specification failed to provide adequate written description.

The CAFC found that the Board did not err in denying Bamberg’s motion to amend the claim set due to a lack of claim chart.


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Written Description

Lee Wright | August 20, 2014

ScriptPro, LLC v. Innovation Associates, Inc.

August 6, 2014

Panel: Taranto, Bryson and Hughes. Opinion by Taranto

Summary:

ScriptPro sued Innovation Associates, Inc, alleging infringement of claims 1, 2, 4, and 8 of U.S. Patent No. 6,910,601. Innovation Associates counterclaimed on various grounds, including invalidity under 35 U.S.C. § 112.

Shortly after suit filed, Innovation Associates initiated an inter partes reexamination of the ’601 patent at the PTO, and the district court stayed proceedings in this case to await the PTO’s determination.

The PTO completed its reexamination of the ’601 patent.  It confirmed amended claims 1 and 2 (amended in ways not relevant to this appeal).  It confirmed claim 4, formerly a dependent claim, as rewritten to be an independent claim, but not otherwise amended. And it confirmed claim 8 without amendment.  The amendments are not relevant to the issues on appeal.

Proceedings in the infringement suit resumed.

The district court granted summary judgment for Innovation Associates, holding that the asserted claims were invalid under 35 U.S.C. § 112.

The district court rested its holding on a single conclusion—that the specification describes a machine containing “sensors,” whereas the claims at issue do not claim a machine having “sensors.”

ScriptPro appealed.

The district court granted summary judgment of invalidity on the ground that the patent’s specification does not describe the subject matter of the asserted claims, which do not require sensors.  This is the only issue on appeal.

The district court agreed with Innovation Associates that the specification indisputably limits the invention to a collating unit that uses sensors to determine whether a particular holding area is full when selecting a holding area for storage of a prescription container.

The district court concluded “no reasonable jury could find that the inventors were in possession of a collating unit that operated without sensors.”

The district court decision is reversed.


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CAFC reminds applicants to be wary of functionally defined genus claims

Linda Shapiro | July 22, 2014

AbbVie Deutschland GMBH & CO., KG et al., v. Janssen Biotech, Inc.

July 1, 2014

Panel:  Lourie, O’Malley, and Chen. Opinion by Lourie. Concurring opinion by O’Malley.

Summary

 Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date.


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Nothing Lost but Nothing Gained: Generic Producer Evades Infringement but Fails to Invalidate Patent under §112.

Adele Critchley | April 3, 2014

Alcon Research Ltd., v. Barr Laboratories, Inc.

March 18, 2014.

Before Newman, Lourie and Bryson. Opinion by Lourie.

Summary:

The CAFC reversed the District Court’s judgment that Alcon’s patents lacked enabling disclosure and sufficient written description as Barr had failed to demonstrate that some experimentation was required, let alone undue experimentation.  Barr’s allegations that the claims were “too broad,” the specification was “too limited,” and the art was “too unpredictable,” was not sufficient without evidence to support that undue experimentation was required in order to practice the patented method.

The CAFC, however, affirmed the District Court’s judgment of non-infringement since Alcon had failed to prove that the polyethoxylated castor oil (“PECO)” in Barr’s product was present in a “chemically-stabilizing amount.”

The CAFC denied Barr’s judgment as a matter of law (“JMOL”) and Rule 59(e) (alter or amend a judgment) motions on non-infringement for the two patents that were omitted from the pretrial order and not litigated.


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Instruction from PTO on Software Composition Claims

Scott Daniels | August 28, 2013

Ex parte Mewherter, 2012-007962 (PTAB, 2013)

The Patent Office rarely designates decisions of the Patent Trial and Appeal Board as being “precedential,” but when it does, practitioners take note.  The Patent Office’s designation last week of Ex parte Mewherter, 2012-007692 as falling in that category will be of particular interest to those handling software patent applications. 
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Amending to exclude a species via a negative limitation may violate the written description requirement

Lee Wright | August 7, 2013

In re Bimeda Research & Development Limited

July 25, 2013

Panel:  Rader, Clevenger, Prost.  Opinion by Clevenger.  Concurrence by Rader.

Summary: 

The court held a negative limitation to exclude a genus does not provide 112, first paragraph written description support to claim a negative limitation that excludes a species, which species was never mentioned in the application.


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