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Patenting expressed sequence tags and single nucleotide polymorphisms

Nature Biotechnology volume 19, pages 777–779 (2001)Cite this article

The scope and content of the patent specification is likely to determine the level of protection afforded EST and SNP inventions.

Today, molecular biologists possess the tools to clone, sequence and identify thousands of potentially useful expressed sequence tags (ESTs) and single nucleotide polymorphisms (SNPs). Patent offices worldwide are dealing with increasing numbers of EST and SNP patent applications, but the route to patent approval is still unclear. In drafting patent specifications, the need for guidance is perhaps greater than ever.

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References

  • Flattmann, G.J. & Kaplan, J.M. Nat. Biotechnol. 19, 683–684 (2001).

    Article  CAS  Google Scholar 

  • See, generally Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), aff'd, 517 US 370 (US 1996).

  • Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

  • 66 Fed. Reg. 1099 (2001); Synopsis of Application of Written Description Guidelines.

  • Synopsis of Application of Written Description Guidelines at 20–22.

  • Structural elements in claims often narrow their scope. For instance, a claim that recites “a natural promoter” is limited to a single structure, the promoter found naturally on the chromosome. In contrast, functional elements may give claims a broader scope. For example, “a promoter capable of expression” may include a gene's natural promoter, a different promoter from that species, a viral promoter, a bacterial promoter, etc. Claiming with functional language, however, may risk invoking a “means plus function” claim construction under 35 USC §112 ¶6.

  • In some instances, however, the PTO will reject a more narrowly drafted claim where the claimed species is not supported by the written description.

  • The decision to claim more broadly and wait for a rejection to narrow the scope must be made in light of the recently decided Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 56 (Fed. Cir. 2000). In Festo, scope of the doctrine of equivalents was restricted. The Festo Court held that where an applicant amends a claim for reasons relating to patentability (e.g., in response to a rejection), the amended element in that claim is entitled to no scope of equivalence.

  • Synopsis of Application of Written Description Guidelines at 23–26.

  • Id at 28–30.

  • Id at 34.

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  1. 1251 Avenue of the Americas, New York, 10020, NY

    Gerald J. Flattmann & Jonathan M. Kaplan

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  1. Gerald J. Flattmann
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  2. Jonathan M. Kaplan
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Flattmann, G., Kaplan, J. Patenting expressed sequence tags and single nucleotide polymorphisms. Nat Biotechnol 19, 777–779 (2001). https://doi.org/10.1038/90843

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