Eisenberg Analyzes the 101 Exception for Patents Claiming Diagnostic

August 4th, 2015

iStock_000011677313_SmallPatentlyO recently posted a nearly final draft of a paper writer by Professor Rebecca Eisenberg that will be published in the Journal of Science and Technology Law (note to author – fix fn 23). (A copy can be found at the end of this post.) She and I have been on the opposite side of issues such as patents for genes at various times, but she nails the purposeful and logically unsupportable rationales of the Fed. Cir. and the Supreme Court that she believes have already ended patent-eligibility for claims directed to diagnostic methods. While I have argued that, even post-Ambry and Ariosa, there should be room for focused claims to diagnostic methods based on the discovery of naturally-occurring correlations, this paper suggests that “It ain’t over ’til it’s over” is hopelessly optimistic.

In some of my earliest posts, pre-Myriad and pre-Prometheus (“Mayo”), I argued that the Metabolites Labs. dissent by Justices Breyer, Stevens and Souter conflated the in vivo existence of cobalamin and homocysteine in the blood with the human act of correlating an elevated level of one with a deficiency of the other. On April 27, 2009, I wrote:

 “Justice Breyer, I respectfully submit that nature may contain [the basis for] correlations but it does not analyze, much less correlate, anything. Nature doesn’t care if your homocysteine level is low or high and what consequences may befall you if it is too high or low. Just as nature doesn’t care what your PSA level is, even though it is certainly a natural phenomenon that men have PSA in their blood. But a claim: ‘Human blood containing PSA’ does not anticipate a claim to a method of detecting prostate cancer by assaying blood for PSA and correlating an elevated PSA level to the presence of prostate cancer. Good thing those patents have expired; they yielded workable life-saving test before they expired.”

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Patent Office Publishes Subject Matter “Update”

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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Innovation Act Stalls in the House

July 17th, 2015

iStock_000001499158_SmallRepresentative Goodlatte’s Innovation Act (H.R. 9) has been shelved for now, and will not receive a floor vote until September at the earlier. There is significant conflict between measures intended to deter patent trolls and the ability of non-profit institutional NPE’s to enforce their patents. Big Pharma wants “out” of IPR entirely.  Action on the corresponding Senate Bill,  S. 1137, will also be postponed.

A 3-page chart comparing major provisions of the bill with IPO positions is available on the IPO website. 

In re Cuozzo – Still no changes for the claim interpretation standard during inter partes review proceedings

July 13th, 2015

iStock_000040556240_SmallA guest post from Theresa Stadheim, attorney at Schwegman Lundberg & Woessner.

In In re: Cuozzo Speed Technologies, LLC, Appeal No. 2014-1301 (Fed. Cir. July 8, 2015, decision by Dyk), the Federal Circuit decided not to review the Patent Trial and Appeal Board (the “Board”) practice of construing patents under the broadest reasonable interpretation (BRI) standard.

Garmin petitioned the Board for inter partes review (IPR) of claims 10, 14 and 17 of Cuozzo’s U.S. Patent No. 6,778,074 (the ‘074 patent). Garmin contended that claim 10 was invalid as anticipated under 35 U.S.C. § 102(e) or as obvious under 35 U.S.C. § 103(a) and that claims 14 and 17 were obvious under § 103(a). Claim 10 recited:

A speed limit indicator comprising:
a global positioning system receiver;
a display controller connected to said global positioning system receiver, wherein said display controller adjusts a colored display in response to signals from said global positioning system receiver to continuously update the delineation of which speed readings are in violation of the speed limit at a vehicle’s present location; and
a speedometer integrally attached to said colored display.

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