Posts Tagged ‘USPTO’

Sequenom’s En Banc Petition

Friday, August 14th, 2015

Sequenom’s Petition for Rehearing En Banc – Panel Ignored “Inventive Concept” in Combined Steps of the Claimed Method

mandmsFor any of us practitioners encountering increasing numbers of s. 101 rejection rejections of diagnostic claims based on Mayo and the March 2014 PTO Guidance – and that is pretty much any life sciences patent attorney – this brief is a “must read.” (A copy of this brief is available at the end of this post.) This brief puts it all out there, both criticizing the panel, proposing a new rule for method claims incorporating natural phenomenon and illustrating how the panel’s application of the Mayo Rule threatens method of medical treatment claims as well as diagnostic method claims.

If I start trying to summarize the Brief, I will not be able to stop. Instead of arguing that the Mayo Supreme Court decision was wrong, the Brief distinguishes the regimen claims in Mayo from the Sequenom claims – that were based on the discovery of cffDNA in maternal serum which, in turn permitted the non-invasive determination of the condition of the fetus. The opinion of the Brief’s authors is that the Sequenom claims adhere to the rationale of Diehr, a decision ignored by the panel. I will quote two paragraphs below, but picking just one to quote is like having to stop after eating a single M&M or one potato chip – nearly impossible:

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Patent Office Publishes Subject Matter “Update”

Thursday, July 30th, 2015

updateToday (July 30th), the Patent Office released an 11 page “July 2015 Update” on patent-eligible subject matter (or not). (A copy of the update and appendices can be found at the end of this post.) Most of the “Update” focused on clarifying the December 2014 revised guidance. Also released were new examples 21-26–including ones modeled on Flook and Diehr. None of the new examples related to the life-sciences. Also released were an Appendix 2 that indexed all of the examples released since December 2014, and an Appendix 3, summarizing all of the case law discussed.

So if you are a life sciences person, you need only peruse the “Update.” It spends considerable space discussing how to apply the December 2014 Guidance, but the takeaway is that you need to rebut the natural product exception with a showing of markedly difference characteristics (2A) or else you fall into the dreaded “significantly more” circle of Hell called 2B. There is also some attempt to clarify the role of the “Streamlined Analysis” and preemption, that I don’t think clarified anything and that Examiners ignore anyway.

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“If Wishes Were Horses” – Roberts’ Dissent from Myriad

Monday, June 29th, 2015

horses2After reading Obergefell v. Hodges, 576 U.S.___(2015), (a copy is found at the end of this post) I was struck by Justice Robert’s dissent – which excoriates the majority for legislating from the bench and basing its opinion on “social policy.”

In AMP v. Myriad, Justice Roberts joined in a unanimous opinion holding that segments of DNA are patent-ineligible “natural products,” reversing a Fed. Cir. panel decision that held DNA to be patent-eligible as a novel chemical molecule.

But what if Justice Roberts disagreed with his brethren and penned a dissent? I have repeatedly taken the position that Myriad was decided on policy grounds, which required the Justices to decide that a novel chemical compound is not a “composition of matter” under s. 101, but is something else.

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Apotex Petitions Supreme Court to Review Therasense Standards

Thursday, May 21st, 2015

Magnesium SaltIn Apotex, Inc. v. UCB, Inc., Appeal No. 2013-1674 (Fed. Cir. August 15, 2014) the court affirmed the district court’s ruling that one actor, Dr. Sherman, the chairman of Apotex had committed inequitable conduct by engaging in what the court found was a perfect storm of misrepresentations during the prosecution of U.S. Pat. No. 6,767,566 that claimed a method to make the magnesium (Mg) salt of Moexipril. The Fed. Cir. found that Dr. Sherman, the named inventor on the application withheld prior art, mischaracterized the cited art in arguments and via a Rule 132 Declaration, and included examples in the application that had not been performed. In fact, this was characterized as an attempt to patent a competitor’s drug.  The  competitor, UCB, had listed in the Orange Book, as the hydrochloride salt – although the court found that Dr. Sherman was aware that the process disclosed in the listed patent, U.S Patent No. 4,743,450, would yield the Mg salt of Moexipril, which imparted substantial stability. The Fed. Cir. agreed with Apotex that Dr. Sherman had no duty to disclose his own suspicions or beliefs regarding the prior art (that he suspected that the ‘450 process would in fact yield the stable Mg salt) but rested its holding on its opinion that Dr. Sherman “affirmatively and knowingly misrepresented material facts regarding the prior art.” Slip op. at 15.

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