Tag Archives: Written Description

35 U.S.C. 112 SPECIFICATION. (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

An Initial Comment on Ariad: Written Description and the Baseline of Patent Protection for After-Arising Technology

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Following on the heels of the Federal Circuit en banc opinion in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Professor Kevin Collins asks "What next?"

The nine-judge majority reaffirms that the written description requirement applies to original claims and that its scope and purpose are to be determined by examining the relevant Federal Circuit precedent. Indeed, but for the fact that it removes the uncertainty caused by the vociferous dissents in earlier written description opinions, the en banc opinion in Ariad could readily be framed as a non-event in the evolution of the written description requirement. However, the importance of removing the uncertainty about the existence of a written description requirement as applied to original claims should not be lightly dismissed. Before Ariad, the uncertainty channeled much of the scholarly conversation about the written description doctrine into a binary debate, pitting those who it applied to original claims versus those who believed that it did not. After Ariad, the stage is now set for greater participation in more nuanced conversations about the role that the written description requirement does and should play in curtailing patent protection. Ariad may end one facet of the debate over written description, but it would be a lost opportunity if Ariad were interpreted to end the debate over written description more broadly and cut off these more nuanced conversations.

In this short (but nuanced) essay, Professor Collins suggests that the next steps in patent law scholarship should adopt a "trans-doctrinal approach" that reaches the broader purposes and limitations of the law rather than being confined to doctrinal silos.  The essay suggests that this holistic approach may also be helpful in explaining a perception that patent law varies greatly according to the area of technology. [Download Collins.Ariad]

Cite as Kevin Collins, An Initial Comment on Ariad: Written Description and the Baseline of Patent Protection for After-Arising Technology, 2010 Patently-O Patent L.J. 24.

Justifying the Decision in Ariad v. Lilly

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In Ariad v. Lilly, defenders of the written description requirement made two primary arguments: (1) that the text of the Patent Act and the accompanying jurisprudential history lead to the conclusion that the statute creates a separate written description requirement; and (2) that the written description requirement serves an important role in policing applicant behavior. An en banc Federal Circuit confirmed that the written description requirement is separate and distinct from enablement, but firmly based its decision on the first argument rather than the second. I believe that the Federal Circuit took the correct approach – especially in its substantial rejection of the second argument. In my recent essay, I wrote that – apart from its value in "new matter" rejections – the role of the written description requirement in ex parte prosecution is negligible. See An Empirical Study of the Role of the Written Description Requirement in Patent Prosecution, 104 NORTHWESTERN UNIV. L.R. Colloquy ___ (2010) (ssrn download). In that essay, I took no position on the larger issue of whether the written description doctrine is nevertheless required by the statute.

In his concurring opinion, Judge Gajarsa explicitly rejects the argument that the written description requirement is a necessary on policy grounds – writing that "[t]he empirical evidence confirms my belief that written description serves little practical purpose as an independent invalidity device [apart from policing priority]." Despite the lack of a policy justification, Judge Gajarsa concurred with the judgment "because the majority's opinion provides a reasonable interpretation of a less than clear statute."

Guest Post: Ariad v. Lily: Choosing to Not Disrupt the Settled Expectations of the Patent Community

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I asked Howard Skaist for his views on the recent decision in Ariad v. Eli Lilly. He wrote the following:

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By Howard Skaist of Berkeley Law, LLC.

In an en banc case closely watched by the patent bar, the Federal Circuit made little change to the law regarding written description and provided little additional guidance, despite a majority opinion nearly 40 pages long, two concurrences, two dissents and having received 25 amicus briefs. At a high level, the case can probably be best understood as having been resolved on policy grounds in the face of an unclear statute and Supreme Court precedent that does not directly address the question at hand; however, policy is only a portion of the justification that the majority of the full court uses for the outcome. 

The fundamental question is whether or not a separate and independent written description requirement exists under 35 USC section 112, first paragraph.  The majority answers the question in the affirmative, relying on the language of the statute, Supreme Court precedent and policy considerations.  However, the concurrence and dissenting opinions demonstrate that this language of the statute is far from clear and that the Supreme Court precedent does not really address the question directly.  Therefore, the main division among the judges appears to rest on policy considerations.  In addition to the policy considerations regarding the advisability of a written description requirement, the majority apparently does not want to “disrupt the settled expectations of the inventing community….”  Majority Opinion at 16. 

The facts of this case suggest that it may have been a good one to test policy rationales since it was brought by a variety of academic and research institutions, including MIT and Harvard, against Eli Lilly.  The inventors had made a fundamental research discovery in biotechnology and hypothesized several possible ways to take advantage of it, but it took those working in the field several more years to successfully develop a product exploiting the discovery.  Therefore, at the core of this case, a legitimate question exists regarding the role or purpose of a patent system and how research or academic institutions should fare under existing legal standards.  Also telling is the citation by Gajarsa in his concurrence of work by Dennis Crouch and Chris Holman showing that few cases have invalidated claims based on written description.  Linn, in his dissent, also cites to Crouch’s work. 

Ariad and a variety of institutions sued Eli Lilly on US Patent 6,410,516 the day the patent issued.  The inventors were the first to identify NF-xB and uncover the mechanism by which it activates gene expression underlying the body’s immune response to infection.  Thus, the inventors recognized and suggested that artificially interfering with NF-xB activity could reduce harmful symptoms of certain diseases.  At the District Court level, a jury determined that Lily infringed the four claims asserted and determined the patent to not be invalid for anticipation, lack of enablement or lack of written description.  However, on appeal, the Federal Circuit reversed and held the patent invalid under 35 USC 112, first paragraph, for failing to provide an adequate written description.  Ariad petitioned for en banc review and the Federal Circuit granted the petition. 

In the en banc opinion, the majority does a good job clarifying the heart of the dispute by stating: “[A]lthough the parties take diametrically opposed positions on the existence of a written description requirement separate from enablement, both agree that the specification must contain a written description of the invention to establish what the invention is.  The dispute, therefore, centers on the standard to be applied and whether it applies to original claim language.”  The point of departure therefore appears to center more upon whether or not original claims can be held invalid for lack of written description or not.  The conventional view had been that a claim supports itself.  However, Federal Circuit decisions in the last few years have challenged that thinking, such as Fiers v. Revel, Enzo v. Gen-Probe and LizardTech v. Earth Res. Mapping.  Here, the Federal Circuit establishes that those decisions were correct. 

As alluded to above, the majority does not agree with Ariad’s arguments about the wording of the statute or its characterization of the relevant Supreme Court precedent.  However, Gajarsa, while concurring, states: “[T]he text of section 112, paragraph 1 is a model of legislative ambiguity.”  Likewise, even the majority, in discussing the Supreme Court precedent concedes: “Although the Court did not expressly state that it was applying a description of the invention requirement separate from enablement, that is exactly what the Court did.” Majority Opinion at 14. Therefore, Ariad’s points may have more substance than the majority concedes. Nonetheless, the Federal Circuit states that “[a]s a subsidiary federal court,” majority opinion at 15, it is obligated to follow such precedent.  The Federal Circuit, however, does directly address Ariad’s contention that original claims should be treated differently than amended claims saying that the distinction does not exist in the language of section 112 and that Ariad has not provided a principled basis for making the distinction being asserted.  Majority Opinion at 19. 

The court challenges directly the thinking that an original claim necessarily supports itself under written description: 

“Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”  Majority Opinion at 20. 

The majority does provide a few clarifying points regarding application of written description: 

“[The] hallmark of written description is disclosure. Thus, ‘possession as shown in the disclosure’ is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.”  Majority Opinion at 24 

The court also acknowledges the disadvantage that this law creates for basic research institutions: 

“[T]he patent law has always been directed to the ‘useful Arts,’ U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical use, see Brenner v. Manson, 383 U.S. 519, 532-36 (1966). Much university research relates to basic research, including research into scientific principles and mechanisms of action, see, e.g., Rochester, 358 F.3d 916, and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered. That is no failure of the law’s interpretation, but its intention.” 

Conceding that enablement and written description are similar, the court nonetheless maintains that in some fields they can be quite different, particularly in chemistry and biotech: 

“Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions. Thus, although written description and enablement often rise and fall together, requiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described.”

The Relevance of Invention Date in Patent Prosecution: Part III

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This is Part III of my series on the relevance of the invention date in patent prosecution. You may download my entire paper here. This part considers the role of provisional patent applications as an incomplete but functional substitute for invention-date rights. 

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With some caveats, I argue that provisional patent applications can serve as functional substitutes for reliance on the U.S. filing grace period. Provisional patent applications have become popular since being made available in 1995. The USPTO reports that applicants filed 143,030 provisional patent applications in fiscal year (“FY”) 2008, compared with 466,147 non-provisional utility applications that year. U.S. applicants file a great majority of these provisional applications Consequently, the provisional filings correspond to more than half of the annual total of utility applications filed by U.S. residents.

A provisional application is essentially a low-cost placeholder that allows an applicant to establish a priority date by filing a description of the invention along with paying an administrative fee to the USPTO. The applicant may later file a non-provisional application claiming the benefit of the provisional application’s filing date. The provisional patent application has a twelve-month non-extendable pendency. During that time-period, the application is kept secret and is not examined. Thus, to rely upon the provisional priority date, the applicant must submit a non-provisional application within one year of the provisional filing date. Professor Seymore notes several additional strategic advantages of filing provisional patent applications: “extending the patent term to twenty-one years, postponing the examination period, trolling for prior art, and avoiding an allegation of inequitable conduct.”

To explore the relevance of provisional patent applications as a tool for claiming priority, I created a dataset of 5000+ provisional patent applications filed between January 1, 2001 and October 1, 2007. Of those, over half (52%) were still secrete as not yet identified in the priority claim of any publicly available non-provisional application. Although some of these will eventually become public as associated with a non-provisional filing, in the end, close to 40% or more of the provisional application filings will never be linked to an issued patent or public non-provisional application.   Collectively, these figures indicate that a large number of provisional applications are themselves left floundering to be abandoned twelve months after filing. The large number of abandoned provisional applications suggests to me that provisional patent applications are likely being used as early place-holders to cheaply secure a priority date, rather than as a means of extending the patent term or postponing examination. In a separate study looking at the 620,000+ issued patents for which applications were filed between 2000 and 2005, I found that seventeen (17) percent of the patents in the data-set claim priority to at least one provisional application. On average, the patents claiming priority listed 1.4 provisional patent applications. In a separate study, I found that on average abandoned non-provisional applications tended to claim priority to 2.0 provisional patent applications. This combining of multiple provisional applications to support a single patent supports this theory that provisional applications as a substitute for filing date evidence. Notably, each provisional can serve as evidence of an incremental advance in place of a corroborated laboratory notebook. Anecdotal reports suggest that this practice has become especially prevalent among universities developing early stage innovations. However, the value of incremental provisional application filings is limited by the hard twelve-month deadline for filing a non-provisional application.

For an inventor who has conceived a new invention, the legal benefits of filing a provisional application, rather than relying on the invention date, are compelling. If the filing deadlines are met, a provisional patent application will serve as conclusive evidence of priority—without any need for any affidavits or declarations—so long as the provisional application discloses the invention claimed in the non-provisional application “in the manner provided by the first paragraph of section 112.” In other words, the specification of the provisional application must “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable” an ordinarily skilled artisan to practice the invention claimed in the non-provisional application.

Unlike an applicant seeking to assert a prior invention date, an applicant claiming priority to a provisional application need not provide corroborated evidence—or indeed any evidence—of actual reduction to practice, conception date, or reasonable diligence in working toward reduction to practice. Rather, the USPTO and courts treat the filing of a provisional patent application as a constructive reduction to practice, thus allowing the applicant to rely on the simple evidence of the paper filing.

An oft-stated disadvantage of provisional application filings is that they may create a false sense of security among patent applicants. Certainly, a hastily-filed provisional patent application may fail to properly describe the invention to be claimed in a later-filed non-provisional application. However, the validity of this criticism does not suggest that applicants should merely rely upon the hope that they will possess sufficient evidence to antedate references based on a prior invention date. Rather, risk-averse applicants should quickly file a well supported application either in provisional or nonprovisional form.

Patently-O Bits and Bytes No. 327

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  • Supreme Court: My sense is that Ariad v. Eli Lilly has essentially no shot for Supreme Court review unless the Ariad can do a great job of convincing the court that the written description requirement as applied is (1) new and (2) is severely detrimental to the patenting of breakthrough inventions and discoveries.
  • Supreme Court: A decision in Bilski is expected in the next 6 weeks – perhaps as soon as March 30.

  • Upcoming events:

    • I am traveling the next 10 days or so, but have pre-written a set of interesting (in my view) blog posts.
    • On the 25th and 26th of March, I'll be speaking at the Miami-based IP Law Summit (then to Disney with the kids…).
    • April 27th, I'll be speaking in New York at the Corporate IP Counsel Summit
    • On April 30, I'll be speaking in Kansas City at a KCMBA IP law event.
    • On May 20, the Federal Circuit is hosting its annual conference with an all-star lineup.
    • Statute of Anne: Two competing conferences are being held on the 300th anniversary of the Statute of Anne (the first copyright statute). (If I were turning 300, I'd want at least two parties.) The first is on March 27 at Cardozo Law School in New York [Link] and the second is on April 9-10 at Berkeley Law School [Link]. Professors Peter Jaszi (American) and Daniel Gervais (Vanderbilt) will be speaking at both events.

Patently-O Bits and Bytes No. 327

Patent,
  • Supreme Court: My sense is that Ariad v. Eli Lilly has essentially no shot for Supreme Court review unless the Ariad can do a great job of convincing the court that the written description requirement as applied is (1) new and (2) is severely detrimental to the patenting of breakthrough inventions and discoveries.
  • Supreme Court: A decision in Bilski is expected in the next 6 weeks – perhaps as soon as March 30.

  • Upcoming events:

    • I am traveling the next 10 days or so, but have pre-written a set of interesting (in my view) blog posts.
    • On the 25th and 26th of March, I'll be speaking at the Miami-based IP Law Summit (then to Disney with the kids…).
    • April 27th, I'll be speaking in New York at the Corporate IP Counsel Summit
    • On April 30, I'll be speaking in Kansas City at a KCMBA IP law event.
    • On May 20, the Federal Circuit is hosting its annual conference with an all-star lineup.
    • Statute of Anne: Two competing conferences are being held on the 300th anniversary of the Statute of Anne (the first copyright statute). (If I were turning 300, I'd want at least two parties.) The first is on March 27 at Cardozo Law School in New York [Link] and the second is on April 9-10 at Berkeley Law School [Link]. Professors Peter Jaszi (American) and Daniel Gervais (Vanderbilt) will be speaking at both events.

Fleshing-Out Design Patent Infringement Doctrine

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Crocs, Inc. v. US International Trade Commission (ITC) (Fed. Cir. 2010) (“In the matter of CERTAIN FOAM FOOTWARE”)

In 2006, the ITC began an investigation to determine whether knock-off imports of the iconic Crocs foam shoes infringed either the Crocs utility patent (Patent No. 6,993,858) or the Crocs design patent (Patent No. D. 517789). After a full investigation, the ITC found no patent violation – holding instead that the utility patent was obvious and that the design patent was not infringed. The ITC also held that Crocs had not established a “domestic industry” relating to the patented product and thus, that the Commission did not have standing. On appeal, the Federal Circuit reversed.

Design Patent Claim Construction:

As is ordinary, the Crocs design patent claims “the ornamental design for ___, as shown and described.” Here, the blank (___) was filled by the word “footwear.” Following utility patent claim-construction precedent the ITC had described the drawings and used that description to limit the claim scope. On appeal, the Federal Circuit rejected that approach and instead holding that in the usual case, a design patent’s drawings typically needs very little textual description. The court also held that design patent claim construction should be less textually detailed because design patent infringement (and validity) are judged by looking at the design as a whole. An element-by-element description unduly draws attention to the details and “away from consideration of the design as a whole.”

This case shows the dangers of reliance on a detailed verbal claim construction. The claim construction focused on particular features of the ‘789 patent design and led the administrative judge and the Commission away from consideration of the design as a whole. This error is apparent in the Commission’s explicit reference to two details required by the written claim construction but not by the ‘789 drawings: (1) a strap of uniform width, and (2) holes evenly spaced around the sidewall of the upper. As shown in Figure 1 of the ‘789 patent, the strap bulges to a greater width at the middle of the strap on the far left of the figure. Thus, the design figure does not require a strap of uniform width between the two round connectors. Also, as shown in Figure 4 of the ‘789 patent, the holes are not evenly spaced. Figure 4 shows a gap in the spacing (particularly towards the big toe). Nonetheless, the written claim description required uniform strap width and uniform hole spacing—contrary to the claimed invention. This error distorts the infringement analysis by the ordinary observer viewing the design as a whole. The administrative judge and the Commission needed to apply the ordinary observer test to “the design shown in Figures 1–7.”

Under the now defunct “point of novelty” tests for both infringement and validity, courts had some justification for describing specific elements of the patented design because those elements would potentially be considered as points of novelty. Although not spelled-out by the court, the recent elimination of the “points of novelty” tests also eliminates that justification.

Design Patent Infringement:

The Federal Circuit outlined the “ordinary observer” test of design patent infringement in its en banc Egyptian Goddess decision. Here, the court fleshed-out that test with further details and nuances. Infringement of a design patent requires proof that an “ordinary observer, familiar with the prior art designs, would be deceived into believing that the accused product is the same as the patented design.” The hypothetical ordinary observer is considered to have knowledge of the prior art. Thus, “if the claimed design is close to the prior art designs, small differences between the accused design and the claimed design assume more importance to the eye of the hypothetical ordinary observer.” “The ordinary observer test applies to the patented design in its entirety, as it is claimed. [Therefore, minor differences between a patented design and an accused article’s design cannot, and [do] not, prevent a finding of infringement.” (quoting Payless Shoesource and Litton Sys.).

The court again emphasized that the test considers the design as a whole and that the court should not use drawing details to create an infringement checklist because “concentration on small differences in isolation distract[s] from the overall impression of the claimed ornamental features.” Rather, a better tool for determining infringement is a side-by-side comparison of the patented design and the accused product.

On the facts of this case, the Federal Circuit found that the allegedly infringing shoes were “nearly identical” to the patented design. “If the claimed design and the accused designs were arrayed in matching colors and mixed up randomly, this court is not confident that an ordinary observer could properly restore them to their original order without very careful and prolonged effort. . . . [T]his court perceives that the accused products embody the overall effect of the ’789 design in sufficient detail and clarity to cause market confusion. Thus, the accused products infringe the ’789 design.”

Domestic Industry:

In a decision of some interest for design patent utility patent holders alike, the Federal Circuit suggested what seems a tight definition of the domestic industry requirement of an ITC Section 337 action. The court wrote:

The test for the technical prong of the industry requirement “is essentially the same as that for infringement, i.e., a comparison of domestic products to the asserted claims.” Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1375 (Fed. Cir. 2003). In other words, the technical prong requires proof that the patent claims cover the articles of manufacture that establish the domestic industry. Put simply, the complainant must practice its own patent.
Although it so stated, I don’t believe that the court actually intended to require that a “complainant must practice its own patent” in order to satisfy the technical prong of 19 U.S.C. 1337(a). Rather, the statute requires that “an industry in the United States, relating to the articles patent . . . exists or is in the process of being established.” The “technical prong” of 337(a)(3)(A)-(B) require significant domestic investment or employment, but neither of those sections require that the complainant be the party that invests.  In the cited Alloc decision, the court stated instead that the question is whether the “industry produces articles covered by the asserted claims.” Here, the dicta is irrelevant because Crocs does manufacture shoes covered by the patent.

Federal Circuit Confirms that Patents Must Meet Both the Written Description and Enablement Requirements of Section 112.

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Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2010) (En Banc Decision).

In a 9-2 decision, an en banc Federal Circuit has confirmed that 35 USC § 112 ¶1 includes separate written description and enablement requirements. “If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.” The court also clearly confirmed the prospect that originally filed claims can violate the written description requirement:

Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.

Possession vs Disclosure: The court did step away from “possession” as the hallmark of the written description requirement. Rather, the court wrote that “the hallmark of written description is disclosure. . . . [T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.”

General Principles: The court presented “a few broad principles that hold true across all cases”: “the written description requirement does not demand either examples or an actual reduction to practice”; however “actual ‘possession’ or reduction to practice outside of the specification is not enough; and a “description that merely renders the invention obvious does not satisfy the requirement.”

Basic Research – Tough Luck: The court recognized that the written description requirement makes it more difficult to patent “basic research” that has not yet been fully reduced to a practical implementation. The court’s reaction to that problem was tough luck. “That is no failure of the law’s interpretation, but its intention. Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.”

That research hypotheses do not qualify for patent protection possibly results in some loss of incentive, although Ariad presents no evidence of any discernable impact on the pace of innovation or the number of patents obtained by universities. But claims to research plans also impose costs on downstream research, discouraging later invention. The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not “attempt[s] to preempt the future before it has arrived.” Fiers, 984 F.2d at 1171.

Holding: For the foregoing reasons, we hold that the asserted claims of the ‘516 patent are invalid for lack of written description, and we do not address the other validity issues that were before the panel. We also reinstate Part II of the panel decision reported at 560 F.3d 1366 (Fed. Cir. 2009), affirming the district court’s finding of no inequitable conduct. The majority opinion was written by Judge LOURIE and joined by Chief Judge MICHEL and Circuit Judges NEWMAN, MAYER, BRYSON, GAJARSA, DYK, PROST, and MOORE. Judges NEWMAN and GAJARSA filed concurring opinions.

Judges RADER and LINN each filed opinions in dissent. [I will write more on this later]

Vacating an Invalidity Rulings as a Condition of a Negotiated Settlement

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Block Financial v. LendingTree (W.D. Mo. 2010)
[File Attachment: Block.v.LendingTree.Invalidity.pdf (25 KB)]
[File Attachment: DismissalReq.pdf (16 KB)]

[Updated March 17, 2010] In 2001, Block Financial sued LendingTree for infringement of its US Patent No. 6,014,645 entitled "REAL-TIME FINANCIAL CARD APPLICATION SYSTEM." Later, Block added assertions of infringement of its US Patent No. 7,310,617 (a continuation application). The case was stayed for several years pending outcome of a reexamination that changed or eliminated about half of the '645 patent's 35 claims.

In a September 2009 order, the district court (W.D. Mo. Judge Smith) issued a partial summary judgment order invalidating many of Block's claims in its '617 patent based on a violation of the "new matter" prohibition of the written description requirement – holding that Block's "February 2002 amendment added new matter to the pending application, which is prohibited by section 132. As those claims are not supported by the original application, they must be declared invalid."

In February 2010, the parties entered into a confidential settlement agreement after the court agreed to vacate its invalidity findings. The parties explained that such an action would serve the public interest:

The court vacating its order would serve the public interest since it facilitates a resolution of the litigation between the parties and the dispute regarding this particular issue. See U.S. Bancorp Mortgage Co. v. Bonner Mall Partnership, 513 U.S. 18, 26 (1994) (holding that vacatur is appropriate when it would serve the public interest). The parties respectfully submit that the vacatur of the court's partial summary judgment order is in the public interest and ask that the court vacate its order in order to allow the parties to settle the current case.

In response to the joint motion vacate, the court issued following order:

The Court is informed that the parties have reached settlement of this case. The settlement contemplates that the Court vacate its Order of September 10, 2009 (Doc # 188). In accordance with the parties' agreement and their joint motion (Doc. # 247), the Court's Order of September 10, 2009 is hereby vacated.

Of course, the US Supreme Court might well contend that the public interest is not being served by this vacatur. In Lear, Inc. v. Adkins, 395 U.S. 653 (1969), the court refused to enforce a contract that barred patent validity challenges – noting a "strong federal policy" in challenging invalid patents and therefore "permitting full and free competition in the use of ideas which are in reality a part of the public domain." A major purpose of this settlement is to remove the black-spot of invalidity from the '617 patent so that it can be asserted against other parties at other times. And, as many have noted, the expense of invalidating a clearly invalid patent is often sufficient to lead to settlement. Of course, once a defendant is relieved of potential liability, it may be quite happy for the patent to remain in effect as a roadblock to other competitors.

See also, Gear Inc. v. L.A. Gear California Inc., 13 USPQ2d 1655 (S.D.N.Y. 1989) (using settlement agreement to vacate judgment of that the term "gear" was generic when used on clothing); Judkins v. HT Window Fashion Corp, 529 F.3d 1334 (Fed. Cir. 2008) (discussing the lower court's decision to vacated ruling of abandonment under 102(g) based on settlement agreement); In re Tamoxifen Citrate Antitrust Litigation, 429 F.3d 370 (2nd Cir. 2005); Aqua Marine Supply v. AIM Machining, Inc., 247 F.3d 1216 (Fed. Cir. 2001).

Patently-O Bits and Bytes No. 322

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PatentlyO036Chicago Area Creative Achievement Award: The Intellectual Property Law Association of Chicago (IPLAC) invites nominations for its 2010 Creative Achievement Award (formerly called the Inventor of the Year Award). In addition to recognizing inventors, the award is intended to recognize significant achievements in the creation of a trademark or service mark and related branding, marketing, and advertising activities, as well as achievements in literary, visual, musical, dramatic, and other arts protected by copyrights. The annual award may fall in any one of these categories for inventive/creative activity conducted in the Chicago metropolitan area. Details on criteria for the award and a nomination form are available on the IPLAC website. Nominations are due by Friday, March 12, 2010. IPLAC will announce the award winner at its Annual Meeting on May 4, 2010. Please email mrichards@brinkshofer.com or call Marc Richards at 312.321.4729, chair of IPLAC's Creative Achievement Award committee, with any questions.

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Patently-O Bits and Bytes No. 322

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PatentlyO036Chicago Area Creative Achievement Award: The Intellectual Property Law Association of Chicago (IPLAC) invites nominations for its 2010 Creative Achievement Award (formerly called the Inventor of the Year Award). In addition to recognizing inventors, the award is intended to recognize significant achievements in the creation of a trademark or service mark and related branding, marketing, and advertising activities, as well as achievements in literary, visual, musical, dramatic, and other arts protected by copyrights. The annual award may fall in any one of these categories for inventive/creative activity conducted in the Chicago metropolitan area. Details on criteria for the award and a nomination form are available on the IPLAC website. Nominations are due by Friday, March 12, 2010. IPLAC will announce the award winner at its Annual Meeting on May 4, 2010. Please email mrichards@brinkshofer.com or call Marc Richards at 312.321.4729, chair of IPLAC's Creative Achievement Award committee, with any questions.

Most popular Patently-O posts during the past month:

  1. Dear Patent Attorney and Patent Agent: Consider Joining to the PTO
  2. Top-Ten Pending Patent Cases
  3. Patent Reform Moving Forward
  4. What Does a Patent Examiner Do with 900+ References?
  5. Ariad v. Eli Lilly: Written Description Requirement
  6. The North Face versus The South Butt
  7. Patent Examiner Experience Levels
  8. Inequitable Conduct Based on Contradictory Statements to the EPO (in a non-family member application)
  9. False Marking False Marking False Marking False Marking all at up to $500 per offense
  10. Viagra, Cialis, & Levitra: Board of Patent Appeals Affirms Rejection of Pfizer’s Broad Patent over ED Treatment

Ariad v. Eli Lilly: Written Description Requirement

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My recent study of BPAI written description requirement jurisprudence was prompted by reading the US Government Brief in the en banc case of Ariad v. Eli Lilly. In the brief, the government indicated its continued support for a separate written description requirement as a tool that the agency uses to eliminate claims during patent prosecution. In sometimes bold font, the government makes its position clear: that a separate written description requirement is "essential to the operation of the patent system;" serves an "indispensable role in the administration of the patent system;" is "fundamental to the operation of the patent system;" and is "necessary for USPTO to perform its examination function." According to the brief, these conclusions are grounded in the USPTO's "practical experience" in "appl[ying] the requirements of Section 112, ¶1 to more than 400,000 patent applications each year."

During oral arguments, the government attorney was pressed for specific evidence supporting its contention that the separate written description requirement serves a practical purpose. As in its brief, the government did not point to any evidence supporting the conclusory statements. The following colloquy at oral arguments between Chief Judge Michel and Mr. Freeman emphasize this point:

Chief Judge Michel: Why does the patent office care? How many applications that can’t be rejected on other statutory grounds will fail only if we [retain the current written description requirement]? . . . I’m asking about impact. . . .

Mr. Freeman on Behalf of the Government: I don’t know an absolute number, your honor, but I think that number must be high. . . .

Chief Judge Michel: I can’t remember ever seeing a patent office rejection that was based only on the failure of written description. I’m not saying there aren’t any, but the flow of cases that come through this court at three or four hundred a year, it is exceedingly rare that the patent office hangs its case on written description. I can’t remember a single case.

Mr. Freeman: Your honor, I don’t have a single case in mind . . . .

Chief Judge Michel: . . . It seems like the practical impact is miniscule, negligible.

Mr. Freeman: Your honor, with all respect, one cannot assume away four-hundred-thousand applications where the written description doctrine comes into play in a great many of them.

My study is essentially directed to the particular questions asked by Chief Judge Michel — How often does the separate written description requirement actually make a difference in patent prosecution? As the data reveals, Chief Judge Michel’s notional recollections from the bench are much more accurate than are the government contentions. I.e., "the practical impact is miniscule, negligible."

[Download the Study]

These results fit well with those of UMKC professor Christopher Holman that he reported in his 2007 article, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO, 17 ALB. L.J. SCI. & TECH. 1, 62 (2007).

An Empirical Study of the Role of The Written Description Requirement in Patent Prosecution

Academic Studies, Articles and Publications, En Banc, Enablement, Patent, ,

Table 3[Download the Draft Essay]

Essay Overview: In the pending case of Ariad v. Eli Lilly, an en banc Federal Circuit is considering whether Section 112 of the Patent Act as properly interpreted includes a written description requirement that is separate and distinct from the enablement requirement. Although the USPTO has no direct role in the infringement dispute, the government submitted an amicus curiae brief arguing that a separate written description requirement is “necessary to permit the USPTO to perform its basic examination function.” However, when pressed during oral arguments the government could not point to any direct evidence supporting its contention.

This essay presents the results of a retrospective empirical study of the role of the written description requirement in patent office practice. It is narrowly focused on rebutting the USPTO’s claim that the separate written description requirement serves an important role in the patent examination process. To the contrary, my results support the conclusion suggested by Chief Judge Michel during oral arguments that it is indeed “exceedingly rare that the patent office hangs its case on written description.”

For the study, I analyzed 2858 Board of Patent Appeals and Interference (BPAI) patent opinions decided January-June 2009. Written description issues were decided in 123 (4.3%) of the decisions in my sample. Perhaps surprisingly, I found that none of the outcomes of those decisions would have been impacted by a legal change that entirely eliminated the written description requirement of Section 112 so long as the USPTO would still be allowed to reject claims based on the addition of “new matter” (perhaps under 35 U.S.C. Section 132). New-matter style written description requirement rejections were outcome-determinative in 20 of the 2858 cases – about 1.0% of the cases in my sample. (I am very confident that the PTO will retain its ability to make new matter rejections even if the separate written description requirement is eliminated.)

Although there may be valid reasons for retaining a separate written description requirement, this study safely leads to the conclusion that the government’s conclusory statements regarding the doctrine’s critical importance for patent examination lack a factual basis.

Continue reading the essay. [PDF]

These results fit well with those of UMKC professor Christopher Holman that he reported in his 2007 article, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO , 17 ALB. L.J. SCI. & TECH. 1, 62 (2007).

Appealing a BPAI Rejection: Can the Applicant Present New Arguments and New Evidence to the District Court?

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Hyatt v. Kappos (Fed. Cir. 2010)

The Federal Circuit has ordered an en banc rehearing of its August 14 decision. The appeal focuses on evidentiary and procedural limits of an appeal of a BPAI decisions to a District Court under 35 USC 145. The Court framed the en banc issues as follows:

(a) Are there any limitations on the admissibility of evidence in section 145 proceedings? In particular—

(i) Does the Administrative Procedure Act require review on the agency record in proceedings pursuant to section 145?
(ii) Does section 145 provide for a de novo proceeding in the district court?
(iii) If section 145 does not provide for a de novo proceeding in the district court, what limitations exist on the presentation of new evidence before the district court?

(b) Did the district court properly exclude the Hyatt declaration?

Background: Hyatt's district court action was originally filed in 2003 as Hyatt v. Rogan after the BPAI sustained written description and enablement rejections for seventy-nine of Hyatt's claims. The examiner had issued 45 separate rejections of Hyatt's claims based on the doctrines of inadequate "written description, lack of enablement, double patenting, anticipation, and obviousness." Complicating the case is the fact that the application's claimed priority date is 1975.

The issues in this appeal case arose when Hyatt filed a civil action in DC District Court to challenge the BPAI decision. In the civil action, Hyatt submitted a new declaration offering additional evidence of enablement and written description. However, the district court excluded that inventor-declaration from evidence based on Hyatt's "negligence" in failing to previously submit the information to the PTO.

Writing for the majority in the original panel opinion, Judge Michel affirmed the exclusion of evidence – holding that the district court may properly exclude evidence that Hyatt should have produced to the PTO. Judge Moore penned a compelling dissent in support of the patent applicant's right to a full civil action including the right to submit additional evidence when challenging a PTO decision.

Briefing: Hyatt's en banc brief will be due around March 31 and the USPTO's response due 28-days later. Briefs of amici curiae may be filed without leave of the court, but must otherwise comply with FRAP 29 and Fed Cir R 29.

* * * * *

35 U.S.C. 145 Civil action to obtain patent.

An applicant dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a) of this title may, unless appeal has been taken to the United States Court of Appeals for the Federal Circuit, have remedy by civil action against the Director in the United States District Court for the District of Columbia if commenced within such time after such decision, not less than sixty days, as the Director appoints. The court may adjudge that such applicant is entitled to receive a patent for his invention, as specified in any of his claims involved in the decision of the Board of Patent Appeals and Interferences, as the facts in the case may appear, and such adjudication shall authorize the Director to issue such patent on compliance with the requirements of law. All the expenses of the proceedings shall be paid by the applicant.

Top-Ten Pending Patent Cases

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Foley attorney Hal Wegner regularly updates his list of the top-ten most important pending patent cases ranked according to their likely impact on the law. The list follows with my own annotations.

  1. Ariad v. Eli Lilly: This en banc case is fully briefed and pending decision on the question of whether the written description requirement of Section 112 should be considered separate and distinct from the enablement requirement. In many ways, the case is about how the law should define the inventor’s “possession” of the invention.
  2. I4i v. Microsoft: A petition for en banc rehearing has been filed on issues of damages and injunctive relief.
  3. Mayo v. Prometheus: This case is on petition for certiorari to the Supreme Court on the question of patentable subject matter for medical diagnostic methods. It has the potential to be a Bilski follow-on.
  4. Bilski v. Kappos: This patentable subject matter case is pending decision at the Supreme Court.
  5. Pequignot v. Solo Cup: Question of intent necessary for false marking charges.
  6. Microsoft v. Lucent: Microsoft is expected to file a petition for certiorari on the “clear and convincing” standard required for invalidating a patent. Microsoft argues that the standard should be lowered when the most pertinent prior art was not considered during patent prosecution.
  7. Arkansas Carpenters: [UPDATED AND CORRECTED] The Second Circuit is considering whether a “reverse payment” from a patentee to an ANDA generic challenger to settle a patent challenge should be considered an antitrust violation.
  8. Costco v. Omega: This case is pending certiorari with an outstanding request for the views of the Obama administration. The case raises an important question of copyright exhaustion in the context of authorized sales of copyrighted material on foreign soil. If decided by the Supreme Court, the case will likely impact patent doctrine.
  9. Princo v. ITC: En banc argument is scheduled for March 3, 2010 on the contours of antitrust and patent misuse in the standard-setting processes.
  10. Acushnet v. Callaway: Whether the legal determination of obviousness should be made by a judge – rendering a jury’s conclusion on that question “entirely advisory.”

Jury Wrong on Anticipation; But Claims are Obvious as a Matter of Law

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[Updated to correct an error]

PatentLawPic901Therasense, Inc. (Abbott) v. Becton, Dickinson and Co. (Fed. Cir. 2010) (Case No. 2009-1008)

The Abbott patent covers a glucose meter designed with an additional sensor that ensures that a sufficient blood sample is obtained prior to the measurement. (Patent No. 5,628,890). Abbott sued BD and Nova Biomed for infringement. At the close of trial, the jury returned a verdict that the patent was infringed but invalid. The jury indicated that the patent was invalid for “anticipation or obviousness” and also invalid for failing the written description requirement of Section 112.

Law of Anticipation: On appeal, the Federal Circuit first determined that the jury instructions on the law of anticipation were incorrect. Notably, the district court judge had told the jury that “for anticipation, it is sufficient if the single reference would have informed those skilled in the art that all of the claimed elements could have been arranged as in the claimed invention.”  (emphasis added). Of course, anticipation requires that the reference disclose the same elements in the same arrangement. 

The requirement that the prior art elements themselves be “arranged as in the claim” means that claims cannot be “treated . . . as mere catalogs of separate parts, in disregard of the part-to-part relationships set forth in the claims and that give the claims their meaning.” Quoting Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1459 (Fed. Cir. 1984).

Harmless Error: Under Federal Circuit law, erroneous jury instructions will lead to vacatur unless the error “could not have changed the result.”  Here, the jury decided obviousness and anticipation together and the Federal Circuit found that the overwelming evidence of obviousness renders the error on anticipation “harmless.”

“[A]n erroneous instruction on the law of anticipation could not have changed the result in this case if claims 11 and 12 would have been obvious as a matter of law, such that no reasonable jury could have returned a verdict that the claims are not obvious.”

Obvious as a Matter of Law: The appellate panel held here that the asserted claims “would have been obvious over [the Nankai reference] as a matter of law.”  The court’s approach to his holding of obviousness will be important for future summary judgment motions.  In particular, Abbott’s downfall was its own broad claim language that encompassed the prior art.  One clear difference between the claims and the prior art was admitted by the patentee to be “insubstantial.”

Written Description: Because the claims were obvious, the court did not consider the written description appeal.

Cross Appeal: BD filed a cross-appeal in the case asking the court to overturn the holding of infringement. The Federal Circuit rejected that cross-appeal — holding that it lacked jurisdiction. Notably, a cross-appeal is only appropriate when “a party seeks to enlarge its won rights under the judgment or to lessen the rights of its adversary under the judgment.” Here, the cross-appeal was improper because a holding of non-infringement would not change the ultimate outcome of the case.

Note: The Federal Circuit has also decided the related case No. 2008-1511 (Therasense, Inc. v. Becton, Dickinson and Co.). That opinion focuses on obviousness and inequitable conduct.

Defective Appeal Briefs

Patent

In an earlier post, I indicated that 40% of appeal briefs are initially rejected as “defective” for failing to comply with the rules of BPAI brief-drafting practice. I pulled-up the file histories for eleven applications whose appeal briefs were rejected in the calendar year 2009. [Table Below] The most common cause for defect in this group occurred when the applicant fails to list previously cancelled claims in the brief. Although that information is included in the appendix of claims, the briefing rules as interpreted by the appeal specialists require that withdrawn/cancelled claims also be identified in the proper section of the body of the brief.

Application Serial Number

Explanation of Defect

9/967,742

Brief did not contain a statement of the status of all claims (e.g., rejected allowed, withdrawn, objected to, cancelled) or does not identify the appealed claims. (The brief did state that “all of the claims have been finally rejected, and the rejections of claims 1-18 and 23-25 is appealed herein.” However, the brief did not state that claims 18-22 were cancelled. Of course, that information was in the appendix of claims.)

10/159,079

Figures of prior art that were pasted into the brief were “unreadable.” (The figures were identified and the prior art was already in the file).

9/983,493

The Brief did not present an argument under a separate heading for each ground of rejection on appeal. (It appears that the problem here is that the applicant underlined the heading for each argument, but did not put the argument in bold.)

10/223,904

The Brief did not contain a reference to a co-pending application also on appeal.

8/873,974

The Brief did not list the cancelled claims. (Of course, that information was in the appendix of claims.)

10/711,517

The Brief did not present an argument under a separate heading for each ground of rejection on appeal. (The argument section did not exactly parallel the grounds-for-rejection section.)

11/484,214

The Brief did not contain a concise statement of each ground of rejection presented for review. (The applicant was appealing one rejection and stated the ground of rejection being reviewed was “Whether the claims fail to comply with the written description requirement under U.S.C. § 112, first paragraph.” The revised and accepted brief instead asked “Whether claims 1-13 fail to comply with the written description requirement under U.S.C. § 112, first paragraph.” Of course, the original brief also stated that “Claims 1-13 are pending. Thus, claims 1-13 are being appealed.”)

10/660,659

The Brief mis-cited the prior art at one point using the wrong patent number.

10/277,646

The Brief indicated that claim 23 was “cancelled,” but the applicant had not actually filed an amendment to cancel the claim.

10/914,894

The Brief did not list all claims and their status, including those withdrawn. (The amended brief added the information that claims 24-42 had been previously cancelled. Of course, that information was also available in the claim appendix.)

10/804,237

The Brief did not list the cancelled claims although that information was available in the claim appendix.

Recent Jury Verdicts

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Cerner v. Visicu, 4-cv-1033 (W.D. Mo., December 8, 2009) (Visicu’s asserted claims held not infringed and invalid as obvious).

Hologic, Inc. et al v. SenoRx, Inc, 08-cv-0133 (N.D. Cal. December 17, 2009) (Hologic asserted claims held not infringed and obvious).

DNT, LLC v. Sprint Nextel Corporation, 03-cv-0021 (E.D. Va. December 14, 2009) (DNT’s claims held not infringed and lacking written description & enablement)

Retractable Technologies, Inc. v. Occupational & Medical Innovations, Ltd., 08-cv.-0120 (E.D. Tex. December 18, 2009) (patent claims held infringed and valid with damages of $1.5 m). Verdict included additional $2.2m for trade secret misappropriation.

Presidio Components Inc v. American Technical Ceramics Corp, 08-cv-0335 (S.D. Cal. December 16, 2009)(patent claims held infringed and valid with damages of $1.0 m in lost profits).

Underlying data via http://lexmachina.com.

  

Patent Law Exam: Pioneering Patents

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Here is the ‘policy question’ from my 2009 patent law exam:

Essay 3 (15 points) < ?xml:namespace prefix ="" o />

 

Congressman I. N. Venter has proposed an amendment to the Patent Act that would create a special right known as a “pioneering patent.” According to the proposal, pioneering patents would be awarded for inventions that are both the product of genius and that dramatically alter the technology landscape. Examples might include the airplane and the polymerase chain reaction (PCR).  The pioneering patent would require greater evidence of nonobviousness, but the applicant would be allowed to pursue broader claims that might not otherwise satisfy the enablement and written description requirements of Section 112.  What are the pros and cons of this proposal? Would a better approach be to extend the patent term a number of additional years for inventions determined to be pioneering? (I.e., longer patents instead of broader patents).

 

 

Cases where Written Description is Satisfied, but Enablement is Lacking

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In Ariad, an en banc Federal Circuit is set to determine whether (and how) the written description requirement is separate and distinct from enablement. The questions presented read as follows:

1. Whether 35 U.S.C. § 112, paragraph 1, contains a written-description requirement separate from the enablement requirement.

2. If a separate written-description requirement is set forth in the statute, what is the scope and purpose of that requirement?

I’m interested in finding cases where the written description requirement has been critical to the outcome. More particularly, I’m interested in seeing cases where the invention is sufficiently described but is not enabled. The recent major written description cases are seemingly only tied to written description doctrine because the panels chose to focus on that argument rather than enablement. A case-in-point is Ariad v. Eli Lilly. As in most written description cases, Ariad’s patent was also challenged on enablement grounds. However, rather than reaching the enablement question, the panel majority held that question moot in the wake of their finding that the asserted claims were invalid on written description. The same result occurred in University Of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2004) (holding that “in view of our affirmance of the district court’s decisions [invalidating the claims] on the written description ground, we consider the enablement issue to be moot and will not discuss it further.”). The LizardTech decision held the asserted claim invalid under both enablement and written description doctrines.

Using the language lf LizardTech, what are examples of cases where the specification provides enough disclosure “to convince a person of skill in the art that the inventor possessed the invention” but not enough to “enable such a person to make and use the invention without undue experimentation.”