How To Write A Patent

by Dennis Crouch

PDF) How to Write Your First Patent | How To Write A Patent Description

The COVID vaccines do not genetically adapt your DNA, but Juno’s patented CAR T-Cell analysis absolutely does. Sloan Kettering owns U.S. apparent No. 7,446,190 and Juno (BMS) is the absolute licensee. The apparent claims a nucleic acerbic polymer (DNA/RNA) that encodes for a accurate “chimeric T corpuscle receptor.” The abstraction actuality is allotment of a advocate CAR T-Cell analysis that genetically modifies a patient’s own T-Cells so that it will be able to admit (and appropriately attack) specific antigens. The inventors accept been awarded abundant accolades for assuming that this access works to amusement some lymphomas. Kite’s “YESCARTA” analysis was begin to infringe.

Juno Therapeutics v. Kite Pharma (Fed. Cir. 2021)

The board awarded the patentees $1.2 billion for Kite’s infringement. On appeal, the Federal Circuit has antipodal — award the claims invalid for abridgement of accounting description.

Functional Bounden element: The claims are directed to DNA (or some added nucleic acid) coding for a “binding aspect that accurately interacts with a called target” in the anatomy of a distinct alternation antibody. But, the apparent does not absolutely acknowledge the DNA arrangement of such a bounden element. That abortion led the cloister to acquisition that the affirmation lacks accounting description.

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The apparent does acknowledge a brace of single-chain antibiotic bits that assignment (and their bounden sites): one acquired from the “SJ25C1 antibody” that binds to B-cell lymphoma cells; and addition acquired from the “J591 antibody” that binds prostate blight cells. The apparent explains how those were acquired used, but does not acknowledge the amino acerbic arrangement of either of these antibodies or their coding nucleic acerbic sequence.

The basal accounting description catechism is whether the functionally claimed “binding element” brand is abundantly accurate by the two examples provided in the specification.

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Written description is a catechism of fact, and the board sided with the patentee — award affliction had not been accurate with bright and acceptable evidence. The commune cloister accurate that cardinal and denied Kite’s renewed JMOL motion. On address though, the Federal Circuit addled the adjudication — captivation that “no reasonable board could acquisition the ’190 patent’s accounting description abundantly demonstrates that the inventors bedevilled the abounding ambit of the claimed invention.”

Full Ambit Accounting Description: The Apparent Act requires that the blueprint accommodate “a accounting description of the invention.” 35 U.S.C. § 112*(a). The blueprint needs to back that the artist had “possession” of the claimed apparatus as of the apparent application’s filing date. Accounting description consistently arises with attention to brand claims — claims accoutrement assorted embodiments. In that situation, the cloister is attractive for control of the “full scope” of the apparatus as claimed. Typically this involves acknowledgment of “either a adumbrative cardinal of breed falling aural the ambit of the brand or structural appearance accepted to the associates of the brand so that one of accomplishment in the art can ‘visualize or recognize’ the associates of the genus.” Ariad. The analysis is alike tougher for functionally-defined brand back anatomy cannot be acquired from the affirmation accent itself.

Here, the cloister begin that the apparent provided “no details” about specific embodiments above “an alphanumeric designation, SJ25C1, as the source”, and no “general characteristics that would allow” the bounden allocation to operate.

Without added guidance, in a all-inclusive acreage of accessible CD19-specific scFvs with so few of them known, no reasonable board could acquisition the inventors annoyed the accounting description requirement.

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Slip Op. During the trial, the patentee’s able assemblage provided explanations apropos how the access actuality has facilitated assorted CD-19 specific antibodies to be acclimated as the way claimed by the inventors. On address though, the cloister reminds us that accounting description charge be apparent in the apparent certificate istelf — not based aloft post-solution activity. “Dr. Sadelain’s affidavit about post-priority date developments, therefore, is extraneous to the analysis afore us.”

Reversed.

= = = =

The case does not go into this, but the aboriginal appliance actuality is a archetype of the attributes biotechnology commodity appear by the inventors in January 2002 forth with 1-page of argument all filed in May 2002. [Provisional App: 52334_60383872]. The issued claims are about identical to those in the non-provisional filed in May 2003.

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