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June 05, 2008

Comments

I agree. It is unpractical and prohibitively expensive to require applicants to provide sequences for all the genes, for example in a gene expression profile. With unigene ID's in GenBank, the revisions, if any, may not alter the claim scope. I don't understand Ms. Burke's rationale.

Kevin and Michael:

In my opinion (and as noted in Kevin's post) the PTO's motivation for raising this issue derives primarily from applications with claims directed to a sequence that is only identified by GenBank number in an application. By the time prosecution is underway, the GenBank sequence information may have been modified from its original version, even though the GenBank number remains the same. While this can confuse things, GenBank provides easy-to-find links to prior versions of sequences relating to GenBank Accession numbers that have had sequence information updated over time. Thus, a reasonable Examiner and/or one of skill in the art can determine (and demonstrate) what the sequence information was at the time of filing.

While this creates a bit more burden on applicants and practitioners, applicants having claims drawn to nucleic acid sequences (with only reference to GenBank Accession numbers) should be made aware of this potential hitch and be prepared to deal with it.

Whether the PTO will attempt to distinguish applications having claims that are sequence-specific from those that are non-specific is another question...

Chris

Dear Michael and Chris:

Insofar as the "rule" is applied solely to claims like "An isolated nucleic acid having a sequence identified by GenBank Accession No. XXXXX," the Office has at least a modicum of logical basis for the rule; for example, if the claim is asserted against an alleged infringer, which sequence do you choose (if there are multiple ones).

The post is concerned with the tendency of the Office to make these "guidelines" into bright line rules, and I can envision an Examiner saying that a claim to an assay for detecting gene expression modulation of a handful of genes, which are identified by GenBank Accession No. in the specification, are not "uniquely identified." Which is ridiculous but not unimaginable.

Thanks for the comments.

Do you have copies of the handouts from the presentation, or know where these might be found?

Considering that many of the genes in GenBank came from one person (specifically from Dr. Craig Venter), the chance of variations and particularly of more representative forms of genes occurring in the future is highly likely. This could cause severe problems with incorporating genes from GenBank by reference, even though that may not be a patentable part of the invention.
Also consider: Her requirement of such a high level of description and specificity is not appropriate in any part of the patent office, as she seems to be requiring the complete specifications of everything, which long has been recognized as unnecessary.

Oh, for the good old days, when the biotech unit had ombudsmen to facilitate appropriate patenting, instead of QA specialists who seem intent on slowing down innovation in America!

Dear nadiamac-

You can find copies of the presentations at http://www.cabic.com/bcp

This is a problem for older cases, but now GenBank accession numbers have a version number. This means no indefiniteness or ambiguity if the sequence later changes. I asked Ms. Burke (at one of the PTO road shows) about disclosing an accession number with a version identifier, but she still felt that this would not be a unique identifier - sounds like a bright line rule already, as Kevin suggests.

Dear Jeff:

In this case, I wish you could have told me I was wrong.

Thanks for the comment (and the info).

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