Written Description: Description Must do more than Allow PHOSITA to “Envision” the Claimed Invention

Goeddel v. Sugano (Fed. Cir. 2010)

When two inventors both claim rights to a single invention, the USPTO is charged with awarding rights to the “first applicant to conceive the invention, provided that [inter alia,] the invention is duly reduced to practice, actually or constructively.” A foreign-filed patent application can constitute constructive reduction to practice “provided that the requirements of §112 are met.”

Sugano filed its original human fibroblast interferon (hFIF) patent applications in Japan in 1979 and 1980 but did not file the claims for the US continuation-at-issue until the 1990s. Meanwhile, Goeddel filed its application in June 1989. In the interference, Goeddel argued that Sugano’s original filings did not provide sufficient disclosure to satisfy the written description requirement of 35 U.S.C. §112 (with respect to the claims being litigated in the interference).

The BPAI (Board) held that Sugano’s 1980 Japanese Application constituted constructive reduction-to-practice of the claims. On appeal, however, the Federal Circuit has reversed – holding that the disputed claims failed the written description test because claimed DNA sequence used to create an hFIF amino-acid sequence was not explicitly defined by the original application.

The Board erred in ruling that priority is established if a person of skill in the art could “envision” the invention of the counts. Sugano argues that this ruling is supported by Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002) and University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 923 (Fed. Cir. 2004), but these cases do not hold that envisioning an invention not yet made is a constructive reduction to practice of that invention. In Enzo Biochem the court confirmed that depositing an actual sample may meet the written description requirement when science is not capable of a complete written description. Enzo Biochem, 323 F.3d at 970. In University of Rochester the court held that the description of the COX-2 enzyme did not also serve to describe all unknown compounds capable of inhibiting the enzyme. University of Rochester, 358 F.3d at 926-27. Precedent in evolving science is attuned to the state of the science, but remains bound by the requirement of showing “that the inventor actually invented the invention claimed.” Bradford, 603 F.3d at 1269; see Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993).

Sugano had argued that the specific DNA sequence coding for the amino acids was not necessary because a person of skill in the art could have identified the sequence and therefore, it was “unnecessary to spell out every detail of the invention in the specification.” The appellate panel rejected that argument – holding that the DNA itself should have been identified since the DNA sequence was claimed.


  • Genentech owns Goeddel’s rights while the Japanese Foundation for Cancer Research owns Sugano’s rights. (Schering is a licensee).

Fractured Claim Construction

Agilent Tech., Inc. v. Affymetrix, Inc. (Fed. Cir. 2009)

Agilent’s microarray hybridization genetic analysis patent issued in 2003. After seeing those issued claims, Affymetrix amended a pending application by adding identical claims in order to provoke an interference. The Agilent patent has a priority date of 1998 while the Affymetrix application claims priority back to 1995. The Board of Patent Appeals and Interferences (BPAI) awarded priority to Affymetrix in 2006. That holding was upheld by a N.D. California district court in 2008.

Here, the Federal Circuit reverses – holding that Affymetrix cannot claim priority back to its 1995 filing because that original application “does not satisfy the written description requirement for the claims at issue.” Written description is particularly relevant in interference cases where one party typically copies claims from another patent document.

Claim Construction in an Interference: Several articles have been written on the complicated and ever-changing scope of a patent claim. At the PTO, claims are usually given their broadest reasonable meaning while in litigation, courts look for how a PHOSITA would interpret the scope, etc.. Phillips teaches that proper claim construction looks at the literal language of the claims as well as supporting information from the specification and prosecution history. In an interference, however, the copied claims originally came from another application.

Faced with a split of precedent, the Federal Circuit here decided to continue with multiple interpretations of an individual claim. Following Spina, the court holds that – for the purposes of the written description requirement – the newly added claims should be interpreted based on the specification and history of the opposing source application. However, following Rowe, the Federal Circuit held that for the purposes of novelty and nonobviousness, the newly added claims should be construed based on the specification and history of the amended application.

To be clear, as this court explained in Rowe, when a party challenges written description support for an interference count or the copied claim in an interference, the originating disclosure provides the meaning of the pertinent claim language. When a party challenges a claim’s validity under § 102 or § 103, however, this court and the Board must interpret the claim in light of the specification in which it appears.

This change in primary interpretative materials allowed the Federal Circuit to also change the claim construction and consequently hold that Affymetrix’s application “does not satisfy the written description requirement for the claims at issue.”


  • As a pending application, Affymetrix’s claims had no presumption of validity. “Thus, Agilent’s burden of proving a lack of written description in Affymetrix’s Besemer application is a simple preponderance of the evidence. Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1365 (Fed. Cir. 2004).”   

In re Gleave: Reference with Unknown Utility Still Anticipates

In re Gleave (Fed. Cir. 2009)

In 2008, the BPAI affirmed the examiner’s rejection of Gleave’s claims as anticipated. The claims focus on an antisense oligodeoxynucleotide designed to bind two different types of insulin-dependent growth factor binding protein (IGFBP). The prior art included a document that listed the genetic sequence of the complementary sense strands but did not identify any utility of the sequence.

On appeal, the Federal Circuit affirmed the anticipation rejection – basing its decision on the rule that anticipatory prior art does need to be functional, useful, or show actual reduction to practice. Rather, to be anticipatory, the prior art must enable the skilled artisan to make the claimed invention.

In the 1973 Wiggins case, the CCPA ruled that the “mere naming of a compound in a reference, without more, cannot constitute a[n anticipatory] description of the compound.” The Federal Circuit here distinguished Wiggins – noting that in Gleave’s case, the sequence listing was sufficient to allow a skilled artisan to “at once envision each member of this limited class.”


Gholz: Linking Post-Grant Review with Interference Procedure

Guest Post by Charles ("Chico") Gholz. Gholz is the head of the Interference Section at Oblon Spivak, a former chair of the Interference Committee of the AIPLA, and a frequent author on interference law and practice. I asked him to provide some thoughts on the proposed post-grant review proposals in the Patent Reform Act of 2009, telling him that I was especially interested in whether we should try to use the interference procedural structure for the new post-grant challenges.

It is my understanding that "the PTO" (actually, the PTO officials directly involved in administering interference matters—by which I mean Chief Administrative Patent Judge Fleming, Vice-Chief Administrative Patent Judge Moore, and Senior Administrative Patent Judge McKelvey) have expected the cancellation proceedings to be a species of the genus contested case and that, accordingly, they would be governed by Part 41, "Practice Before the Board of Patent Appeals and Interferences," Subpart D, "Contested Cases," of 37 CFR. To those of us in the interference bar, that makes perfect sense, since the cancellation proceedings will be very, very similar to the first phase (formerly known as the "preliminary motions phase") of patent interferences—except that only one party will be filing substantive motions.

However, proposed 35 USC 326 in both bills provides that "The Director shall prescribe regulations…" governing the post-grant review proceedings (what I'm referring to herein as "cancellation proceedings"). Apparently the drafters of the bills (who I suspect are not members of the patent bar, let alone members of the interference bar!) either were unaware of 37 CFR 41 Subpart D or felt that either additional or different rules would be required for the cancellation proceedings.

Whether the cancellation proceedings are to be governed by Subpart D or by a different set of rules is not an insignificant point. Proposed 35 USC 326(a)(3) in both bills would require the Director to prescribe regulations "setting forth procedures for discovery of relevant evidence, including that such discovery shall be limited to evidence directly related to factual assertions advanced by either party in the proceedings, and [that] the procedures for obtaining such evidence shall be consistent with the purpose and nature of the proceeding." However, while that language could be read as mandating real discovery (i.e., discovery similar to the discovery available in district courts), the bills then go on to mandate that, "In carrying out paragraph (3) [i.e., in providing the rules for discovery], the Director shall bear in mind that discovery must be in the interests of justice," which might be read a giving the PTO room to provide for only the extremely limited kind of discovery that is currently available in interferences. See Gholz, Patent Interferences – Big Ticket Litigation With No Effective Discovery, 4 Intellectual Property Today No. 9 at page 10 (1997).

Similarly, proposed 35 USC 326(b) in both bills would provide that "Regulations under subsection (a)(1) [including the regulations governing discovery]…shall provide for discovery upon order of the Director [actually, it would presumably be upon order of the APJ handling the proceedings]," indicating that, in contrast to district court procedure, the burden of showing entitlement to discovery would be on the party seeking discovery, rather than imposing on that party's adversary the burden of showing why discovery should not be obtained.

Proposed 35 USC 326(b) in both bills would also require the Director to issue regulations providing "for filing under seal exempt from publication requirements" and providing for "protective orders governing the exchange and submission of confidential information"—both of which would be sharp departures from current interference practice. See Gholz, Compelled Testimony, Testimony Abroad, and Protective Orders in Interference Proceedings Under the New Rules, 67 JPTOS 239 (1985). However, 35 USC 326(b) then goes on to say that the Director's regulations "shall ensure that any information submitted by the patent owner in support of any amendment entered under section 329 is made available to the public as part of the prosecution history of the patent." Since the "confidential information" is more likely to be submitted by the patent owner than by its adversary, I wonder how often a protective order will actually issue. Or is the point that the protective order will automatically expire upon conclusion of the cancellation proceeding?

Both the House version and the Senate version of proposed 35 USC 334 govern the effect on cancellation proceedings of decisions in other proceedings (only an infringement action in the Senate version, but either an infringement action or an ITC action in the House version). Surprisingly, both versions seem to assume that the decisions of the courts (or the courts and the ITC), on the one hand, and the decisions of the Board, on the other hand, are of identical issues—despite that fact that the party attacking a patent has a lower burden of proof before the Board and therefore might win before the Board even though it would lose before a court or the ITC on identical evidence.

In sum, I'd like to express my hope that the drafters of the two bills will consult with experts on interference law and practice, both in the PTO and in the private bar, before passing either version of the bill.