Ex Parte Stone: The “Disappearing Doctor” Leaves a Medical Device Behind

I know that Fed. Cir. s 101 decisions are inherently more instructive than PTAB decisions, but PTAB (and district court) s. 101 decisions are like legal potato chips – if you sample one, you just can’t quit. For example, in Ex Parte Stone, Appeal no. 2017-002188 PTAB, May 3, 2018), the Examiner’s rejection of claims to a system for monitoring bladder fullness as directed to a natural product, namely a human, was reversed.
The main claim is deceptively simple:

Claim 1. A system comprising:
a sensor configured to general a signal indicative of mechanical oscillation of a bladder of a patient; and  a processor configured to receive a signal from the sensor, determine the oscillation frequency of the bladder based on the signal, and take a responsive action based on the oscillation frequency. Continue reading

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PTO Releases Revised Guidance on Compliance with Mayo/Alice Rule

On April 19, the USPTO released a Memorandum from Robert Bahr, The Deputy Commissioner for Patent Examination Policy, that summarized the support required for a finding if a claim directed to a judicial exception to s. 101 eligibility under Step 2A of the Mayo/Alice analysis chart of MPEP 2106 – a natural phenomenon, an abstract idea or a product of nature [ ed. note “PAIN’]– contains an additional inventive concept that, taken alone or in combination, would not represent well-understood, routine, or conventional [“WRC”] activity. The Memorandum was prompted by the recent decision in Berkheimer v. HP, 881 F.3d 1360 (Fed. Cir. 2018).

At virtually the same time, Director Iancu released a Request for Comments on Determining Whether a claim element is [WRC] for the Purposes of Subject Matter Eligibility, and it pretty much repeats the factors listed in the Bahr Memorandum. For a detailed summary of the factual underpinnings that an examiner must make in order to support a rejection on the basis that a claim directed to a PAIN does not meet the inventive concept requirement because it is WRC, please refer to my post of April 20th. Continue reading

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PTO Proposes to Change Claim Construction Standard Used by PTAB

On May 9th, the USPTO released a short “Notice of proposed rulemaking” entitled “Changes to the Claim Construction Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board.”  In brief the Notice proposes to replace the broadest reasonable interpretation standard for construing unexpired patent claims that is used by the PTAB in IPR, post-grant review and the transitional program for covered business method patents, with the Phillips Standard used by the district courts. This standard requires that the claims are given “the meaning that [a] term would have to a person of ordinary skill in the art at the time of the invention.” The courts give primary weight to intrinsic evidence – the specification, and the prosecution history—but can consult extrinsic evidence such as technical treatises and even expert testimony, if needed. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005). The Federal Circuit has been using the BRI standard to decide appeals from PTO proceedings, but uses the Phillips standard for appeals from the district courts. Continue reading

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Ex Parte Buck: Can a Composition Claim be a Natural Phenomenon?

In a recent decision, Ex Parte Buck, Appeal no. 2017-005470 (PTAB, April 20, 2018), the Board affirmed the examiner’s ruling that a composition claim reciting two natural products was patent-ineligible as an attempt to claim a natural phenomenon:

7. A kit comprising multiple, separate weekly or
monthly doses of
a) Vitamin D, and
b) 25-OH D3 [a metabolite of Vitamin D],
wherein a dosage ratio of the Vitamin D3 to the 25-OH D3
is from about 6:1 to 1:6; a single weekly dosage contains from
7 μg to 350 μg each of Vitamin D and 25-OH D3; and a single
monthly dosage contain from 30 μg. (The last 4 words are not a [typo; they were construed to read “contain at least 30 μg.”)

Before I dig into this decision, please re-read my March 19, 2018 post on In re Bhaghat, where I attempt to set out the rules of  101 inquiries for claims directed to “natural products.” In brief, if a claim is directed to two or more natural products, the nature-based combination is examined to see if the combination of components has “markedly different” characteristics due to the interactions of the components of the composition. Continue reading

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