Archive for the ‘Patentable Subject Matter’ Category

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

Friday, July 8th, 2016

Tfda officehe FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this post.) The strategies involve the generation of reliable diagnostic conclusions for patients based on one or, oftentimes, many many mutations that are compared to those of other patients and to reference databases. Under “Scope,” the FDA has stated:

“[T]his paper discusses factors and principles to identify genetic databases that are of sufficient quality to support a regulatory submission…..[T]his paper discusses data quality and database operations as applied to the clinical interpretation of human genetic variants, i.e., for establishing the link between variants and the risk or diagnosis of disease or other states of health.”

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Rapid Litigation v. CellzDirect – A Break in the 101 Wall

Tuesday, July 5th, 2016

On Julybreak-in-wall 5, 2016, a three judge Fed. Circuit panel of Moore, Prost and Stoll (Appeal no. 2015-1570) reversed the district court’s holding that claims to a method of isolating “hardy” twice -frozen hepatocytes (as I called them in my post of April 26 summarizing the oral argument) were patent-ineligible as no more than a law of nature accompanied by routine cryopreservation steps. (Please go here and read my summary of the oral argument – it will save me some typing time.) )A copy of the decision can be found at the end of this post.)

In that post, I noted that Judges Moore and Stoll hold technical degrees and appeared undaunted by Mayo and the resulting Mayo/Alice test for patent-eligibility. Although Judge Prost did not ask as many questions of the parties during oral argument, she joined in the decision.

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Bascom v. AT&T — Patent Eligibility Meet Patentability

Tuesday, July 5th, 2016

…..Or Judge reverseNewman proposes a blended approach when “Abstract Idea” or “Inventive Concept” is at issue. In Bascom v. AT&T, Appeal no. 2015-1763 (June 27, 2016, Fed. Cir.), panel of Judges Newman, O’Malley and Chen reversed the district court’s finding that Bascom’s U.S. Pat. No. 5,987,606 failed step two of the Mayo/Alice test, since was simply a combination of conventional steps carried out using generic computers. (A copy of the decision can be found at the end of this post.) The panel reversed, calling this a close case but found an inventive concept in claims to an individualized internet content filtering system patent eligible since “an inventive concept can be found in the non-conventional and  non-generic arrangement of known, conventional pieces.”

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Due May 24 — Comments On Improving Patent Quality Metrics

Monday, May 23rd, 2016

iStock_000072606049_SmallMany patent attorneys received a notice recently, copied below, alerting them to efforts by the US Patent Office to improve patent quality.

The notice references a “Master Review Form”. A preliminary version can be found at:
http://www.uspto.gov/sites/default/files/documents/MRF.pdf

Not only does this Form serve as a “checklist” for how examiners are supposed to process your application, it provides an indication of how prosecution will be graded by the Office.

Once the Form is finalized, you can use it to fortify your responses, so that when you find something missing in an Office Action, you can explicitly point out how the Examiner has failed to properly address certain aspects of the rejection.

If you are able to promote the missing content as a significant deficiency, noted as such in bold type in the response, and using the same words that are on the Form, you might just get a second chance at allowance.
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