Archive for January, 2013

ACLU Files Petitioners’ Brief in AMP v. Myriad Appeal

Monday, January 28th, 2013

On January 13th, AMP et al. filed a 59 page brief contended that human DNA, including DNA fragments, RNA and cDNA, should not be considered patent-eligible under 35 USC s. 101. There is a lot to read here, much of it argued and re-argued in past reviews, but a few points stand out—way out.

Petitioners’ arguments rely on three primary propositions. The first is that DNA is a natural product that is not “markedly changed” by isolation from the body, because it is “foremost an informational molecule.” But this argument is undercut by their argument that “[i]solation is a necessary step in any serious study, research, clinical or commercial use” and “it is currently not possible to use genes, including looking at or sequencing them, without removing or ‘isolating them’”. Brief at pages 41 and 5. Doesn’t that compel the conclusion of a change of some sort from the gene as it exists in vivo? Also, in conflating the sequence (…ATTAGGAA…) with the actual isolated molecule, AMP ignores a long line of precedent that holds that, e.g., MeCO2H, may contain information about the structure of acetic acid but it is not acetic acid – that a claim to a compound is directed to both its formula and its properties.

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USPTO Publishes Final Rules for Micro-Entity Status and Fee Schedule

Thursday, January 17th, 2013

On December 19, 2012, the Patent Office published the final rule: “Changes to Implement Micro Entity Status for Paying Patents Fees” –77 Fed. Reg. 75019–and on January 18, 2013 the final fee schedule is expected to be published (link below). The Micro Entity status rules occupy 16 pages in the Federal Register, including the public comments. The primary meat of the Rules is the discussion of new sections 1.29(a) and  1.29(d) which set forth the requirements of individual inventor/applicants. Since most patent applications will still be filed by inventor/applicants (as opposed to institution/applicants, these are the sections that have the potential to save both individuals and certain institutions a lot of money (for example, a micro-entity can file a request for prioritized examination for only $1000).

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PTO Issues Notice on Improvement in Patent Application Quality – A Very Modest Proposal

Wednesday, January 16th, 2013

On January 15, 2013, the USPTO released a notice – see link below – requesting comments on its suggestions of ways to “improve the quality of issued patents” by improving the quality of application drafting. There are two brief sections in the Notice: “Clarifying the Scope of Claims” and “Clarifying the Meaning of Claim Terms in the Specification.” Since this is a biotech blawg, I will skip the sections relating to software and means-plus-function clauses.

The suggestions in Part A boil down to: (1) Write claims in outline form with elements in lettered or Roman numeral-designated subsections, (2) Minimize or eliminate preambles (the Office wants us to indicate if we think they are limiting, so let’s stop using them), (3) Specifically identify support for claim elements in the specification (No – should only be “necessary”– if at all — when claims are amended – original claims are part of the specification), (4) Indicate whether or not examples are intended to be limiting or “merely illustrative” (Easy one - they are always illustrative).

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Supreme Court Denies Cert. in Sherley v. Sebelius

Wednesday, January 9th, 2013

The pesky worry about a possible Supreme Court review of the ruling by the D.C. Court of Appeals affirming the Circuit Court’s dismissal of a challenge to the 2009 NIH Stem Cell Funding Guidelines – which permitted NIH funding of most stem cell research – was lifted today when the Supreme Court denied plaintiff’s petition for cert. With the re-election of President Obama, who initially lifted the ban on all but very limited stem cell research imposed by President Bush, hopefully the U.S. will return to a position of leadership and help this area of research mature.

Click here to read the story from the Stem Cell Action Coalition.