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September 15, 2014


Very interesting - thank you for this write-up, Kevin! So: one of the three independent claims (21) and its dependent claim 22 are now officially not invalid under 35 USC 103 - even when construed and analyzed in a way most unfavorable to the patentee (and, oh boy, did the Board strain in its claim construction. Can't fault them for not trying to invalidate these claims...)

As you note, the same claims have been held ineligible under Section 101 in district court. Since Alice, dozens of patents have been invalidated under 101 (some on the pleadings) in district courts around the country. By at least some accounts, many of these claims, on computer-implemented business methods, "look" invalid anyway (under 102 or 103 or 112). Many people can't get exercised if a patent that's probably invalid anyway is struck down, even if it's done under the Mayo/Alice smell test. As Dennis noted on the other blog, the real problems arise if you start wiping out patents that manifestly meet every requirement of patentability (and it increasingly looks like this patent is one of those).

Here are at least two claims that are (I) apparently novel and nonobvious; (II) claiming a transformative and widely-adopted prenatal diagnostic method, and that (III) don't preempt anyone from offering diagnostic services for the same indication using alternative methods. I hope the Board decision, upholding these claims, will make for a more thoughtful CAFC appeal from the district court's 101 decision. The Federal Circuit has done nothing in this appeal for months, apparently waiting for the Board to catch up. Hopefully there'll be some movement now.

Very nice analysis. I am writing this as a scientist (who has written and obtained some patents), but without a great depth of legal knowledge as it pertains to claim construction. However, I think this particular patent should be a relic of history. There is no method reduced to practice in this patent that would have allowed for the appropriate level of quantitative accuracy that is necessary to make this a viable tool - and it's not even close. Everything in the patent relies upon using established techniques like PCR. Next generation sequencing was not available at the time and we now know that is what is required to make this work. The next generation (massively parallel sequencing) patents are currently undergoing litigation between Sequenom and Illumina (the erstwhile Verinata). In this patent you have the use of the original discovery (by Kazakove and Lo) of circulating free DNA that increased with duration of pregnancy. Once you had that idea - guess what? There was nothing to be done because the technology of the time wasn't good enough for a diagnostic test. This contention of mine is proved by the fact that Sequenom and Lo tried for 14 years using different methods to develop a viable test. In the end, both Sequenom (proved) and Lo had to resort to fraud to get their RNA method to appear to work. It didn't and then next gen sequencing came along and made most of the prior work irrelevant. Therefore, I don't see anything in this patent that would have taught the reasonably skilled in the art person of the time a method for determining things like aneuploidy. When you add in the paternal limitation all you have, imo, is the seed of an abstract idea - "hey wouldn't it be cool if we could somehow measure the fetal DNA in mom's blood to learn things about the fetus." By the way, the original paternal limitation was included in the patent at the request of the examiner because nobody had any idea how you were going to differentiate the tiny fetal fraction from the maternal DNA which has a concentration about a factor of 10-1000x higher. Therefore, the spirit of the paternal limitation was really about using it as a method and should have rightly limited all the claims (although that strong scientific reason was thrown out by the court at the last claim construction hearing).

Further, and please correct me if you think I am wrong, it would appear to me that every claim in the patent is dependent upon claim 1 and if that is invalidated doesn't the whole thing fall apart? I have read this patent thoroughly, and I can't see how any of the other claims can really be construed as being independent of claim 1.

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