Written Description II

Prof Merges

Sept. 7, 2010

Casebook p. 305

“In this case, the original disclosure clearly identifies the console as the only possible location for the controls. It provides for only the most minor variation in the location of the controls, noting that the control “may be mounted on top or side surfaces of the console rather than on the front wall . . . Without departing from this invention.”

Univ of Rochester v. Searle

Univ. of Rochester v. GD Searle & Co., 358 F.3d 916 (Fed. Cir. 2004)

Traditional non-steroidal anti-inflammatory drugs ("NSAIDs") such as aspirin [and] ibuprofen . . . are believed to function by inhibiting the activity of enzymes called cyclooxygenases. Cyclooxygenases catalyze the production of a molecule called prostaglandin H[2], which is a precursor for other prostaglandins that perform various functions in the human body

Patent in suit, owned by University of Rochester, was for a method of treating inflammation using inhibitors of prostaglandin H synthase-2 (PGHS-2) enzyme activity, also known as “COX-2”

Dr Donald Young, Dr Virginia Winn, and Dr Kerry O'Banion

Claim 1: ‘850 Patent

1. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.

Claimed method of using a compound acting upon a polypeptide did not comply with the written description requirement where such a compound was not disclosed.

• Spec. did not disclose which, if any, compounds selectively inhibit PGHS-2

Cyclo-oxygenase Enzyme

SLIDE NAMETraditional Painkillers: block Cox enzyme from producing

prostaglandins

Rochester discovery: selective Cox 1 inhibition

Selective antagonist

Cox-2 Inhibitors

Celebrex

COX-2 Inhibitors: $13 billion mkt!

‘850 Patent Spec

“The present invention provides a simple in vitro system for the screening of drug actions on both the constitutive and the inflammatory cyclooxygenase, which will be useful for the development of drugs that selectively inhibit inflammation without producing the side effects due to inhibition of constitutive prostaglandin production.”

High-Throughput Screening: Finding Hits

District court opinion

The '850 patent neither discloses any actual Cox-2 inhibiting compound nor provides any suggestion as to how such a compound could be made or otherwise obtained other than by trial-and-error research. Indeed, the court found no evidence in the '850 patent that the inventors themselves knew of any such compound at the time their patent application was filed.

Federal Circuit opinion

• Enablement and WD – separate requirements

• Relationship? – confused!!

Bottom line: holding

“Without such disclosure [of specific peptides, etc. selectively inhibit Cox 2] the claimed methods cannot be said to have been described.”

Example: Selective Serotonin Re-uptake Inhibitors, e.g. Prozac

Up to the minute on written description . . .

Goeddel vs. Sugano

Interference appeal decided

• No. 2009-1156,-1157

• Avail. at http://www.cafc.uscourts.gov/images/stories/opinions-orders/09-1156-1157.pdf

Note dates

• Sugano priority filing:

Issue

• Human fibroblast in-terferon (“hFIF”), also called interferon beta or β-IF

• “Mature” vs. initial forms

• Recombinant mature form in dispute here

That a modified gene encoding the 166 amino acid protein could have been “envisioned” does not establish [priority]. The question is not whether one skilled in this field might have been able to produce mature hFIF by building upon the teachings of the Japanese Application, but rather whether that application “convey[ed] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) – p. 13

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.” – p. 14

Lizardtech v. ERM424 F.2d 1336 (Fed. Cir. 2005)

• Data compression technology

• Mathematical “transforms” used to convert and compress data, stored as arrays

• If the correct transform is chosen, the majority of the information is stored in a relatively small portion of the array.

Lizardtech

• Once we have chosen DWT as the transform, how do we implement DWT quickly and efficiently?

• DWT works by splitting the image data using two filters. The low pass filter retains the low frequency data, such as broad areas of color. The high pass filter retains the high frequency data, such as edges and textures.

The prior art centers the filter on each element in the tile. The Lizardtech method also centers the filter on elements outside the tile that have been set to 0. This is a means of calculating not only the coefficients for the tile loaded into memory, but also the effect of that tile on later calculated coefficients. In effect, the sums are broken up and calculated in pieces. This results in a seamless transform that is exactly the same as if DWT had been run on the entire, unbroken image.

ERM Uses a Continuous Sliding Window Approach: This technique never breaks up or tiles the image. so it does not introduce any edge artifacts. Instead, it relies on the critical observation that contrary to what was previously thought, the DWT process does not need to generate the entire intermediate images before generating the output sub-band images. The newly-patented ERM method uses this observation to perform a standard prior art DWT technique, but does so by structuring the data flow to ensure that only the minimum amount of data required is stored in memory at any one time.

The problem is that the specification provides only one method for creating a seamless DWT, which is to "maintain updated sums" of DWT coefficients. That is the procedure recited by claim 1. Yet claim 21 is broader than claim 1 because it lacks the "maintain updated sums" limitation. Thus, a person of ordinary skill in the art would understand that claim 21 is directed to a seamless DWT. But because there are no limitations in claim 21 as to how the seamless DWT is accomplished, claim 21 refers to taking a seamless DWT generically.

The trouble with allowing claim 21 to cover all ways of performing DWT-based compression processes that lead to a seamless DWT is that there is no support for such a broad claim in the specification. The specification provides only a single way of creating a seamless DWT, which is by maintaining updated sums of DWT coefficients. There is no evidence that the specification contemplates a more generic way of creating a seamless array of DWT coefficients. . . . P. 324

Yingbin-Nature (Guangdong) Wood Industry Co. v. International Trade

Commission

U.S. Court of AppealsFederal Circuit

535 F.3d 1322 (Fed. Cir. 2008)

The tongue is shaped such that, upon insertion into the groove, the lower lip of the groove is displaced a small distance from its original position. The lower lip has an “elastically yieldable or bendable portion,” whereby the lower lip tends to return to its original position when displaced.Thus, when the tongue and the groove are coupled together, the lower lip of the tongue exerts a force against the groove … which draws adjacent floor panels toward each other.

“Clearance” claims

According to Power Dekor, the disclosure of the original ′044 application does not convey with reasonable clarity to those skilled in the art that the inventor possessed the invention—i.e., the concept of clearances—later claimed in claims 5 and 17. Power Dekor contends that the later-claimed concept of “clearances” was not discussed in the original specification; . . .

[R]ather, it was introduced as new matter in the application leading to the ′779 patent through alterations to fourteen paragraphs, the introduction of new reference numbers in certain figures, and the addition of two completely new paragraphs.

[T]he ′779 patent's claims cover the very internal voids that were shown and described in the original disclosure. In addition, they contend that merely adding the generic word “clearance” to describe those spaces did not constitute new matter. Finally, Unilin and the Commission argue that there is nothing improper about using the term “clearance” in two different ways within the ′779 patent—in one way to describe the “recess” of an uncoupled panel and in another to describe different voids formed between two coupled panels.

The internal voids recited in claims 5 and 17 of the ′779 patent are all shown and described in the disclosure accompanying the original ′044 application. “[O]pen spaces” are depicted in at least Figures 7 and 23 of the original disclosure. The spaces were originally described as “dust chambers,” whereas the ′779 patent application was amended to refer to the spaces as “dust chambers or clearances.” [T]he spaces were described as having “the advantage that [they] do not exert an adverse influence upon good engagement.”

• No written description problem with these claims.