28Oct 2019

Finally, a few diagnostic method claims have been found patent eligible. This is not a Court decision, but rather a decision reached by the Patent Trial and Appeal Board (PTAB). The claims under the PTAB were:

1. A method of determining an increased risk of colorectal cancer or Crohn’s disease in an asymptomatic human subject, comprising:

(i) collecting mucosal epithelial cells from the buccal area of the subject by swabbing the buccal area, and extracting RNA from the swab; 

(ii) producing cDNA from the extracted RNA; 

(iii) measuring the level of cDNA for a panel of polynucleotides comprising at least three cDNA sequences comprising SEQ ID NO: 1, 21 and 23 from the cDNA produced from the extracted RNA; 

(iv) applying each of the measured cDNA levels of the panel of polynucleotides against a database of Mahalanobis-distance (M-dist) values created by analyzing measured cDNA levels of a control panel of polynucleotides from control subjects with no polyps and no family or self-history of cancer or known upper GI problems, wherein the control panel of polynucleotides and the panel of polynucleotides comprise at least three cDNA sequences; wherein the applying compares the same polynucleotides expression levels for each of the at least three cDNA sequences using global multivariate analysis of variance (ANOVA) and Mahalanobis-distance (M-dist); wherein the M-dist has chi-square distribution with degrees of freedom equal to the number of polynucleotides in the panel; wherein the database comprises M-dist values for at least three cDNA sequences comprising SEQ ID NO: 1, 21 and 23; and wherein the database is stored on a computer system; 

(v) determining the M-dist values for each of the at least three polynucleotides comprising SEQ ID NO: 1, 21, and 23 of the panel of polynucleotides from the asymptomatic human subject; and 

(vi) indicating that the asymptomatic human subject has an increased risk of colorectal cancer or Crohn’s disease if each of the M-dist values for the cDNA levels for the at-least three cDNA sequences of SEQ ID NO: 1, 21 and 23 are greater than the 95% percentile of the database’s M-dist values. 

During prosecution, the Examiner had rejected the claims for being directed to “a law of nature,“ a naturally occurring correlation between the naturally occurring expression of the SEQ ID NOS: 1, 21 and 23 and the risk of colorectal cancer or Crohn’s disease.

But the PTAB disagreed that the claims’ limitations were ordered and well known and conventional. Thus, the PTAB concluded that even if the claims may be directed to a natural phenomenon or law of nature, and the prior art might teach or suggest individual steps recited by the claims, the evidence does not support a conclusion that the claimed steps constitute mere routine and customary actions that do not provide the “something more” than the natural law upon which they may rely so as to provide an inventive concept.

Hopefully, this PTAB opinion will help open the way to obtain eligibility for more diagnostic method claims.

Please contact me at silvia@salvadorilaw.com with questions or comments.

Silvia Salvadori, PhD

Silvia Salvadori, PhD