Friday, July 18, 2008

The Punched Drunk Eye of Schrodinger's Cat

Ex parte Cynthia Roberts (USPTO BPAI 7/15/08) is sufficiently "perturbing" to stir me out of my blogging hiatus.

Since when is a perturbed eyeball not a composition of matter in an altered state?

If a thing is measured, is it not quantum mechanically in an altered state due to entanglement with the measuring device?

Here's the background:

Claim 120. A method for improving refractive ophthalmic treatment comprising:
[a] obtaining a first, pre-operative diagnostic measurement of an individual cornea of an eye;
[b] determining a first operative corneal ablation specification based on the first, preoperative diagnostic measurement;
[c] obtaining non-tissue removing perturbation data from the individual cornea before ablation to obtain a biodynamic response data from that individual cornea;
[d] obtaining a second, post-perturbation, preoperative diagnostic [second] measurement of the individual cornea;
[e] correlating said non-tissue removing perturbation data with the biodynamic response data gathered from a statistically significant number of corneas; and
[f] establishing an individual customized laser ablation specification for corneal ablation for that individual cornea, based at least in part on said biodynamic response data.

Are you with me so far?

The body of claim 120 ties itself to a composition of matter (an individual eyeball) and inherently requires perturbation of the eyeball in order to obtain the recited bio-"dynamic" response. (There is another claim 99 in the case that explicitly recites perturbation.)

So what does the USPTO Board of Appeals say about the 101 eligibility of claim 120?

You guessed correctly:

"The claim does not include any recitation of a particular machine used to implement the claimed steps. The steps could be performed entirely by a human being with no machine involvement whatsoever."

"[A]bsent the development of some hitherto unknown type of technology, “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.” ... Claim 120 fails to recite transformation of subject matter into a different state or thing. ... [O]btaining data and measurements relating to the cornea ... is a combination of data gathering and mental steps. No transformation of subject matter occurs in these method steps."

"Claim 120, however, does not recite that the individual customized laser ablation specification is established by a computer. The claimed method is not tied to a computer anywhere in the claim."

[So there you have it straight out of 35 USC 101: Whoever invents or discovers a a new and useful process, only if tied to a computer, or an improvement thereof may apply for a patent therefor.]

Wait. There's more. The Board gives us their scholarly analysis of Arrhythmia Research Tech. v. Corazonix Corp., 958 F.2d 1053, 1056 (Fed. Cir. 1992). However, this rant is long enough. We leave it to the readers to grok the rest of Ex parte Roberts for themselves.


Step Back said...

Here are some details out of the Roberts application:

"[0012] The biomechanical response--as used herein, the term "biomechanical response," sometimes used interchangeably with. "biodynamic response," means a mechanical or physical response to a perturbation or other stimulus--has not been directly incorporated into current ablation algorithms. As a result, predictability of the visual result currently achievable, even in "customized" wavefront-guided or topography-guided procedures, has been inadequate. There are significant differences in the material properties of living human corneas based on age, sex, race, climate, years of contact lens wear, etc. Thus, there are significant differences in the response of various individuals to similar ablative profiles. The ability to predict the biomechanical response of the cornea to a photoablative procedure, and account for it in ablation algorithm design would significant enhance quality of vision produced. Knowledge of individual biomechanical properties, prediction of individual reponses, and individual adjustment of generalized ablation profiles would allow individual customization, rather than optimizing to the mean population response. Therefore, a biomechanical model with predictive capabilities would significantly enhance the overall success rates of these refractive surgeries."

Step Back said...

More details:
"Characterization of the Biomechanical Response

[0078] In a study to characterize the biomechanical corneal response to LASIK, and separate the resulting refractive effect from that produced by the ablation profile, 8 eyes of 4 subjects have been enrolled and analyzed. LASIK is performed with a Summit Apex Plus using a Krumeich-Barraquer microkeratome to make the flap. Corneal measurements are acquired pre and post-operatively with optical coherence tomography and the following corneal topographers for validation of effect: EyeSys, Humphrey Atlas, Keratron, Orbscan II, PAR, Technomed C-Scan, and TMS-1. Average pre-operative refractive error of the small preliminary group is -6.875.+-.2.03 diopters sphere +0.8125.+-.0.51 diopters cylinder. Only the Orbscan corneal topography data will be presented here. "

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