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« XY, LLC v. Trans Ova Genetics, LC (Fed. Cir. 2020) | Main | Chromosomal Rearrangements Associated with Chemotherapeutic Drug Resistance »

August 03, 2020

Comments

That was a ton of words without actually delineating what the revision to the decision actually was.

I admit that somewhere in there the point of the revision may have been included, but the search party looking for it now needs another search party to find it.

As Francisco said to Barnardo in Act 1 of Hamlet: "For this relief much thanks."

Thanks for noting the amended decision statement that: ("Roche[] has presented no evidence that thresholds of 500 base pairs and 300 base pairs were conventional for separating different types of cell-free DNA fragments."). I.e., the method specifically claimed is apparently novel.

Skeptical: I could find the following differences between the two opinions:

March: The claims in this case are directed to methods for pre- paring a fraction of cell-free DNA that is enriched in fetal DNA. The methods include specific process steps—size discriminating and selectively removing DNA fragments that are above a specified size threshold—to increase the relative amount of fetal DNA as compared to maternal DNA in the sample. ’751 patent col. 7 ll. 63–67. Those process steps change the composition of the mixture, resulting in a DNA fraction that is different from the naturally-occurring fraction in the mother’s blood. Thus, the process achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenome- non.

August: The claims in this case are directed to methods for pre- paring a fraction of cell-free DNA that is enriched in fetal DNA. The methods include specific process steps—size discriminating and selectively removing DNA fragments that are above a specified size threshold—to increase the relative amount of fetal DNA as compared to maternal DNA in the sample. ’751 patent col. 7 ll. 63–67. The size thresholds in the claims—500 base pairs in the ’751 patent and 300 base pairs in the ’931 patent—are not dictated by any natural phenomenon, particularly because the size distributions of fetal and maternal cell-free DNA overlap each other (i.e., there are maternal DNA fragments shorter than 300 base pairs). The claimed size thresholds are human-engineered parameters that optimize the amount of maternal DNA that is removed from the mixture and the amount of fetal DNA that remains in the mixture in order to create an improved end product that is more useful for genetic testing than the original natural extracted blood sample.Moreover, the claimed methods achieve more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon. The claims include physical process steps that change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood.

March: Here, in contrast, the claims are directed to more than just the correlation between a DNA fragment’s size and its tendency to be either fetal or maternal. And the claims do not merely cover a method for detecting whether a cell-free DNA fragment is fetal or maternal based on its size. Rather the claimed method removes some maternal DNA from the mother’s blood to prepare a fraction of cell-free DNA that is enriched in fetal DNA. Thus, the claims in this case are different from the claims that we held invalid in Ariosa.

August: Here, in contrast, the claims are directed to more than just the correlation between a DNA fragment’s size and its tendency to be either fetal or maternal, a correlation which is not even mentioned in the claims. The claims do not cover a method for detecting whether a cell-free DNA fragment in a previously-prepared sample is fetal or ma- ternal based on the natural size distribution of cell-free DNA fragments; rather, the claimed methods exploit that natural size distribution during the sample preparation steps to remove some maternal DNA from the mother’s blood. Even the “analyzing” step of the claims is not di- rected to analyzing the discovered natural phenomenon, but to analyzing something else entirely, namely, “fetal chromosomal aberrations.” See ’751 patent col. 7 ll. 55–56, col. 8 ll. 56–57, col. 9 ll. 5–8; ’931 patent col. 9 ll. 17–24. Thus, the claims in this case are different from the claims that we held invalid in Ariosa.

March: The Court stated:
It is important to note what is not implicated by this decision. First, there are no method claims be- fore this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA . . . are not at issue in this case.

August: The Court stated:
It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents, were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach, and are not at issue in this case.

August: Here, we encounter the opposite situation, i.e., the claims do not cover separated cell-free fetal DNA itself but rather a process for selective removal of non-fetal DNA to enrich a mixture in fetal DNA. That process includes size parameters that the inventors engineered to balance the practicalities of the specific problem that they were facing, namely, removing enough cell-free maternal DNA to enrich the mixture while leaving enough cell-free fetal DNA to allow for testing. Thus, the Supreme Court’s decision in Myriad is not on point in this case where the inventors claimed to have conceived and reduced to practice, not the separated DNA, but a method that uses unconventional size pa- rameters to perform the separation.

Except for the inclusion of the last paragraph above, there is little real difference between the two opinions. And while adding to the distinctions the court made between this case and Myriad (and its earlier decision in Ariosa v. Sequenom, I don't think these differences change the scope of the opinion.

If you can add anything please do.

Thank you Dr. Noonan - any idea on why a second recent case has been 'amended?'

That's next

Patience is not my strong suit, Dr. Noonan.

When is 'next?'

It has arrived - thank you!

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