Ex Parte Nagy – The Reach of the Mayo/Alice Rule Exceeds Its Grasp?

Posted on August 15, 2018 by Warren Woessner

Alzhiemer's DiseaseThe final rejection of the claims of Nagy’s application Serial No. 14/223,113 was affirmed by the PTAB on July 30, 2018 (Appeal 2017-008793). One of the “representative” claims was directed to the holy grail of diagnostics – the early diagnosis of Alzheimer’s disease (AD):

  1. A method of assessing the risk of AD progression in a human subject suspected of having AD, which method comprises:

(i) obtaining lymphocytes from said human subject suspected of having AD and from an age-matched healthy subject with normal cognitive ability;

(ii) inducing cell division in the lymphocytes taken from the human subject suspected of having AD;

(iii) separating the dividing lymphocytes of (ii) into two pools and treating one pool of lymphocytes with rapamycin;

(iv) assaying the level of protein of at least one interleukin selected of interleukin (“IL”) 1 beta (IL1B), IL-2, IL-6 or IL-10 in the pool of lymphocytes treated with rapamycin and in the untreated pool;

(v) comparing the level of protein of the at least one interleukin obtained in (iv) for the pool of rapamycin-treated lymphocytes and the untreated lymphocyte pool to quantify the change in protein levels in response to rapamycin;

(vi) repeating steps (ii)-(iv) using control lymphocytes taken from the age-matched healthy subject with normal cognitive ability; and

(vii) determining that said human subject suspected of having AD is at increased risk of AD progression when (a) the reduction of IL1B or IL10 protein levels in response to rapamycin is higher in control lymphocytes as compared to lymphocytes taken from the human subject suspected of having AD [and/or] (b) the reduction of IL-2 or IL-6 protein levels in response to rapamycin is lower in control lymphocytes as compared to lymphocytes taken from the human subject suspected of having AD….

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Ex Parte Young – Expanding the Scope of an “Abstract Idea.”

Posted on August 9, 2018 by Warren Woessner

DNA SequencingOn July 18th, in appeal no. 2017-007443, the PTAB reversed the Examiner’s rejection to an improved method of manipulating the huge amount of DNA sequence information or “text strings” that are provided by applying the techniques of massively parallel sequencing (MPS) to a sample containing “one or more nucleotide sequences” that are first amplified by PCR. A first plurality of “text strings” – DNA sequences – is selected, wherein “each of the selected plurality of text strings represent[s] a nucleotide sequence that corresponds to a first target locus in the [PCR] amplified sample. In terms of data manipulation, the claim has three more steps: a “comparing” step (or a determination of an “abundance count”), an “identifying step” to detect “noise responses” and a “determining step” to yield a “method detection limit from the abundance count.”

In a review article about next generation DNA sequencing, M.W. Anderson et al, Genes, 1, 38-69 (2010), various MPS methodologies are described: “First, the DNA sequencing libraries are clonally amplified in vitro…. Second, the DNA is sequenced by synthesis, such that the DNA sequence is determined by the addition of nucleotides to the complementary strand rather though through [Sanger] chain termination chemistry. Finally, the spatially segregated amplified DNA templates are sequenced simultaneously in a massively parallel fashion, without the requirement for a physical separation step.” This sequencing step apparently yield the text strings of claims 1 and 12. Continue reading →

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Interval Licensing v. AOL — Judge Plager’s Concurring Dissent

Posted on July 23, 2018 by Warren Woessner

The majority of the panel in Interval Licensing v AOL, Appeal no. 2016-2502, -05, -06, -07 (Fed. Cir., July 20, 2018) affirmed the district court’s finding that claims 15-18 of U.S. Pat. No. 6,788,314 are invalid as attempting to claim and abstract idea without reciting further elements that amount to an “inventive concept,” as called for by the Alice/Mayo test. Ed.’s note: You can skip the next 11 paragraphs, which discuss the panel’s reasoning, to get to the really interesting part of the decision.

The majority of the panel Taranto and Chen (writing) did a thorough analysis of the claims directed to a computer readable medium for use by a content display system that uses an “attention manager” that makes uses of unused capacity of a display device, by displaying content in that unused capacity. Inter alia, the attention manager can use the capacity to display content in an area of the display screen not used by already-displayed content with which the user is actively engaged. Put simply, this embodiment is the display of a second set of data in an area that does not overlap with an already displayed first set of data.

The panel affirmed the district court’s holding that the claims amounted to an impermissible attempt to claim an abstract idea, and that the 9 functionally-claimed “generic sets of instructions” of the attention manager were conventional and well-known to the art. Continue reading →

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Is Judge Kavenaugh an Enemy of Agency “Chevron Deference”?

Posted on July 12, 2018 by Warren Woessner

FDA Application and Gov. RegulationOther commentators have noted that they believe that Judge Kavanaugh (“K”) does not like “Chevron deference” of the courts to the interpretation of agency regulations. I skimmed recent decisions and note, that in technical areas, the judge recognized that deference should be given to an agency’s implementation of their own regulations. In Ivy Sport Medical, a 2014 decision relating to FDA’s inherent authority to reclassify a medical device, K recognized that deference should be given to agency “expertise.” (He still found that the FDA lacked the power to circumvent the procedures required to reclassify a medical device, but does this contradict deference to the technical aspects to the device, in this case, a surgical mesh?)

In a 2013 decision Cytori Ther. v. FDA, K again wrote a court should not second guess an agency’s “scientific expertise.” In that case the plaintiff argued that its cell collection an storage device was equivalent to earlier devices and so was entitled to a simplified review. K. agreed with the FDA that there was a reasonable basis for the FDA’s ruling that the devices in question were not equivalent to earlier approved devices.

That being said, K was unafraid of doing deep analyses of the technical aspects of Cytori’s devices and of the FDA’s power to decide what classification should be applied to a particular device (or to change a classification). In other words, K could accept the agency’s characterization of the device in question but still interpret the FDA’s application of the governing regulations.

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