Last month, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was issued to the patent examining corps, an updated list of court decisions (Supreme Court and Federal Circuit) addressing subject matter eligibility, and an updated index of eligibility examples, that guidance provided six additional life sciences examples numbered 28-33 (33 being the total number of examples that the Office has issued to date).
We previously discussed Example 29, which concerns exemplary claims directed to the diagnosis and treatment of the hypothetical disease julitis. Today, we discuss Example 31, which includes five claims directed to methods for screening for an alteration of a BRCA1 gene, hybridizing BRCA1 sequences, or amplifying BRCA1 sequences. The example notes that the five claims include one actual claim (claim 1) from U.S. Patent No. 5,753,441, and four hypothetical claims (claims 70, 75, 80, and 85) modeled after the technology described in the '441 patent. The example also notes that claim 1 was found to be patent ineligible in Association for Molecular Pathology v. U.S. Patent and Trademark Office (Fed. Cir. 2012).
In the example, applicant has discovered the "wild-type" sequence of the human BRCA1 gene and naturally occurring alterations from this sequence that are correlated with an increased likelihood of developing breast or ovarian cancer, and applicant has disclosed methods of screening patients for alterations in the BRCA1 gene by comparing a patient's BRCA1 sequence with the wild-type BRCA1 sequence. The example notes that at the time applicant's application was filed, DNA sequences were routinely compared by either hybridizing two different DNA molecules and detecting whether the sequences form a hybridization product, or by amplifying a portion of a DNA molecule and then sequencing the amplification product. The example also notes that at the time applicant's application was filed, the technique of Scanning Near-field Optical Microscopy (SNOM) was not commonly or routinely used by scientists to study DNA hybridization (even though the use of this technique to study hybridization had been discussed in several articles in widely-read scientific journals). The example further notes that at the time applicant's application was filed, the hypothetical technique of Cool-Melt polymerase chain reaction (Cool-Melt PCR) was not conventionally used to amplify mutant nucleic acids (even though this technique became a standard laboratory technique for amplifying mutant nucleic acids several years after the application was filed).
The five claims presented in Example 31 are as follows:
1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
70. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:
hybridizing a wild-type probe to a BRCA1 gene isolated from said sample; and
detecting the presence of a hybridization product by measuring conformational changes in the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field optical microscopy.
75. A method for hybridizing BRCA1 sequences comprising:
hybridizing a wild-type probe to a BRCA1 gene isolated from a tissue sample from a human subject; and
detecting the presence of a hybridization product by measuring conformational changes in the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field optical microscopy.
80. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:
amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids; and
sequencing the amplified nucleic acids.
85. A method for amplifying BRCA1 sequences comprising:
amplifying by Cool-Melt PCR all or part of a BRCA1 gene from a tissue sample from a human subject using a set of primers to produce amplified nucleic acids; and
sequencing the amplified nucleic acids.
According to the example, all of the claims but claim 1 are considered to be patent eligible.
In analyzing the claims presented in Example 31, the Office explains that claim 1 is directed to an abstract idea because "it is apparent that the step of comparing [recited in the claim] could be performed by a human using mental steps or basic critical thinking," adding that "[s]imilar mental processes have been held by the courts to be abstract ideas." The Office further explains that apart from the single step of comparing and the wherein clause (which are identified in the example as the abstract idea), there are no other elements/steps recited in the claim. Because "the claim as a whole does not amount to significantly more than the abstract idea of comparing information," the Office concludes that claim 1 is not patent eligible.
With respect to claims 70 and 80, the Office explains that because both claims depend from claim 1 and incorporate the comparing step of claim 1, claims 70 and 80 are directed to a judicial exception. However, the Office also explains that both claims recite additional elements that "yield[] a claim as a whole that is significantly more than the judicial exception itself." In particular, claim 70 recites a detecting step that uses a technique (i.e., SNOM) that while known to scientists at the time the application was filed, was not "actually routinely or conventionally used by scientists . . . to detect DNA hybridization," and therefore "distinguishes claim 70 from well-understood, routine and conventional methods of detecting DNA hybridization such as autoradiography." Similarly, claim 80 recites an amplification step using a technique (i.e., Cool Melt PCR) that "was used by a few scientists in the field to amplify nucleic acids at the time the invention was made and the application was filed," but was not "actually routinely or conventionally used by scientists in this field at the time the invention was made and the application was filed." The example notes that "use [of either technique] by only a few scientists does not make the technique routine or conventional in the field as a whole." Thus, claims 70 and 80 are found to be patent eligible.
With respect to claims 75 and 85, the Office explains that neither claim includes steps that "recite or describe any recognized exception." In particular, claim 75 recites a hybridizing step and a detecting step and claim 85 recites an amplifying step and a sequencing step. Because neither claim 75 nor claim 85 contains steps that recite of describe any recognized exception, the Office notes that the analysis of these claims ends with eligibility at Step 2A, and that the Step 2B analysis does not need to be performed.
Patent Docs will provide summaries of other life sciences examples in subsequent posts.
