United States Copyright Office

Library of Congress 101 Independence Avenue SE Washington DC 20559-6000 www.copyright.gov

February 11, 2014

DNA2.0

Attn: Howard Simon

1140 O'Brien Drive, Suite A

Menlo Park, CA 94025

Correspondence ID: 1-K1L4R4

Original Correspondence ID: 1-DH5IGE

Dear Mr. Simon:

Copyright Office letter affirming refusal to register the

I am writing in response to your request for reconsideration of the Registration Program's refusal to register the DNA sequence entitled the "Prancer DNA Sequence." I apologize for the delay in responding, but this request was an issue of first impression for the U.S. Copyright Office and as such, was given significant consideration prior to rendering a decision. After carefully reconsidering the registration materials and the arguments contained in your request for reconsideration, the Office affirms the refusal of registration.

Copyright Office letter affirming refusal to register the

The Office's decision is based primarily on three principles of copyright law. First, that to be copyrightable, a claim must be based on an "original work of authorship" falling within the congressionally established categories of authorship in title 17. 17 U.S.C. §102(a) and H.R. Rep. 94-1476, 51–53. Second, copyright protection does not "extend to any idea, procedure, process, system, method of operation, principle, or discovery, regardless of the form in which it is described, explained, illustrated, or embodied in such work." 17 U.S.C. §102(b). Third, to be copyrightable, an original work of authorship must include a sufficient quantum of copyrightable authorship. The Office finds that the Prancer DNA Sequence fails on all three of these principles.

Copyright Office letter affirming refusal to register the

I. DNA falls outside of the categories of copyrightable by Congress

In your argument in support of copyright protection for the Prancer DNA Sequence, you emphasize that this is a human-engineered, synthetic DNA sequence rather than a naturally-occurring DNA sequence. Were this a naturally-occurring DNA sequence that was "discovered" by your client through a process of isolation, the matter would be simply resolved by §102 as further clarified by the Feist decision: "one who discovers a fact is not its 'maker' or 'originator.' The discoverer merely finds and records." Feist Publications v. Rural Telephone Service Co., 499 U.S. 340, 347 (1991). Your assertion that this work is created rather than discovered will, for purposes of this review, be accepted as such. Yet, the extent to which any genetic sequence can truly be entirely human-created is unclear, particularly with respect to copyright creativity. Since the operation of DNA is dictated by laws of biology, at least some aspects of DNA sequences are controlled by those laws. Moreover, to the extent that any sequence involves the isolation of any naturally-occurring sequence, or a derivation thereof, it may not be deemed created as opposed to discovered. It is of great concern to the Office that neither this critical distinction nor the degree of creative human authorship can be established through the examination of the deposit. The inability of the Office to independently discern new creative authorship suggests that a claim in a DNA sequence may be far better suited for the realm of patent, where a heighted standard of novelty, nonobviousness, and an examination of prior art would be considered, rather than the originality standard of copyright.

However, because this claim has been submitted for copyright registration, the Office applies the principles of copyright law. Assuming arguendo that this sequence is not a discovery or the isolation of a naturally-occurring sequence, it nevertheless must qualify as an original work of authorship to support a claim of copyright.

The first question to address is whether this sequence qualifies as copyrightable subject matter. You argue this sequence is fixed because "DNA is composed of stable chemical nucleotides" and because "DNA possesses definite sequences of nucleotides that can easily be determined, copies known to last for at least many thousands of years with its nucleotide sequence intact." First Request for Reconsideration, at 2. You further argue that "[u]sing synthetic biological techniques, it is routine to design and construct new, human-designed DNA sequences. Because a synthetic biologist designs particular DNA sequences, and 'writes,' or fixes, them when she synthesizes those sequences, she is an author." Id.