I would ask for prior art, but I'm more curious how close you think this and what the consensus on inequitable conduct is?

U.S. Patent No. 8,282,155 filed in 2009 and claiming priority to 2006.


Inventors are listed as:Holmes; Elizabeth A. (Palo Alto, CA), Roy; Shaunak (San Mateo, CA), Howard; John (Saratoga, CA), Wang; Chengwang (Palo Alto, CA), Gibbons; Ian (Portola Valley, CA), Kemp; Timothy M. (San Jose, CA), Qi; Shize Daniel (Arcadia, CA).

Claim 1 of the patent states:

  1. A two-way communication system for detecting an analyte in a bodily fluid from a subject, comprising:

a) a reader assembly comprising a programmable processor that is operably linked to a communication assembly;

b) an external device configured to transmit a protocol to the communication assembly;

c) a test device configured to be inserted into the reader assembly, said test device comprising: i) a sample collection unit configured for collecting a sample of bodily fluid suspected to contain an analyte; ii) an assay assembly containing reactants that react with said sample of bodily fluid based on the protocol transmitted from said external device to yield a detectable signal indicative of the presence and/or concentration of said analyte; and iii) an identifier that is configured to provide the identity of said test device and is also configured to trigger the transmission of said protocol that is selected based on said identifier;

wherein the programmable processor of the reader assembly is configured to receive said protocol from said external device, wherein said protocol in turn effects (1) a reaction in said assay assembly for generating said signal, and (2) selection of a detection method for detecting said signal, and wherein said reader further comprises a detection assembly for detecting said signal which is transmitted via said communication assembly to said external device.

Now for the reference by Ian Gibbons one of the named inventor. It is not of record.

U.S. Patent No. 4,756,884


"This invention provides devices and methods, where the devices rely upon capillaries, chambers, and orifices to pump fluids; to control measurement of fluids, reaction times, and mixing of reagents; and to determine a detectable signal. By varying the path through which the fluid flows, one can provide for a variety of activities, such as mixing, incubating and detecting. The methods may involve the binding of homologous members of a specific binding pair, resulting in complex formation. The complex formation can provide for a variety of events which can be detected by instrumentation or visual means. Alternatively, the methods may involve chemical reactions, for example, the detection of glucose or serum enzymes, which result in a detectable change in the sample medium. Since the devices rely upon capillaries and other chambers to control movement of fluids, accurate control of the dimensions of the internal chambers is essential. The fabrication techniques described later provide this accurate control."

"The analytes of interest are widely varied depending upon the purpose of the assay and the source. Analytes may include small organic molecules, such as drugs, hormones, steroids, neurotransmitters, growth factors, commercial chemicals, degradation products, drugs of abuse, metabolites, catabolites, etc. Large organic molecules may be determined, such as nucleic acids, proteins, polysaccharides, or the like. Aggregations of molecules may also be of interest, particularly naturally-occurring aggregations such as viroids, viruses, cells, both prokaryotic and eukaryotic, including unicellular microorganisms, mammalian cells such as lymphocytes, epithelial cells, neoplastic cells, and the like."

Which would also raise the plethra of Biotack Inc. 501k filings -


Also makes one wonder about the other Biotrack patents such as

EP0397424A3 (Ian Gibbons) ("A clinical analytical system, comprising (1) an analytical cartridge (10) comprising at least two sample containing means (20, 40) in which analytical reactions take place, wherein (a) each of the sample containing means contains reagent means wherein (i) at least one of the reagent means is present in only one of the sample containing means, (ii) all analyses are relevant to a single medical evaluation, (iii) each of the analyses requires no more than 150 µl of sample, and (iv) all reactions required for the analyses occur in the cartridge, and (b) the cartridge (10) is formed from a plastic housing having dimensions no larger than 1 x 6 x 8 cm; and (2) an analytical instrument (100) comprising (a) registration means (110) for retaining the analytical cartridge in the instrument; (b) detector means (210) for detecting results of the analyses; (c) message means (120) for providing an alphanumeric message to a user of the instrument; (d) verification means (220) for verifying proper operation of at least one step of each of the analyses; (e) control means (200) for processing electronic information provided by the detector means and the verification means and relaying the information to the message means; the analytical instrument being no larger than 15 x 20 x 25 cm, the instrument reporting results of the analyses in no more than about 10 minutes.")

EP0395384A3 ("A system for customizing the output of a clinical analysis instrument is disclosed, in which unique codes contained on a cartridge insertable into the analytical cartridge location of the instrument (or a different location in some embodiments) are utilized for customization, for example, to establish the language in which the prompts will be presented to the user or the units of measurement which will be displayed.")

Assume knowledge and intent, thoughts on IC?

  • We are now in a "but for" regime for inequitable conduct post-Theresene so it would need to be dead on, not just material.
    – George White
    Mar 25, 2013 at 17:18
  • In your excerpts I do not see a two-way communication system.
    – George White
    Mar 25, 2013 at 18:23
  • 1
    If you have legitimate concerns about inequitable conduct, perhaps you should obtain professional advice from qualified counsel.
    – Yorick
    Mar 25, 2013 at 18:29
  • "Two-way" - excellent point. It is references in the preamble but not the claim - unless you see it somewhere. Gibbons goes from Biotrack to Aclara Biosciences where he appears to be in 2003. The Aclara "analyte identification" device references "one-way or two-way communication". See US20005/0115837.
    – user3359
    Mar 25, 2013 at 19:56


You must log in to answer this question.

Browse other questions tagged .