Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Claims
Claims 1-20 are pending and the subject of this NON-FINAL Office Action. This is the first office action on the merits.
Claim Rejections - 35 USC § 112- Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
In claims 1-10, the meaning of “leukocyte genes” is unclear. The specification never defines this phrase. The specification fails to clearly discloses any metes and bounds, such as a specific list of genes. Instead, the specification, like the claims, simply assumes the reader understands “leukocyte genes.” Yet, this is not a well-defined phrase in the art. Skilled artisans do not agree on a universally-accepted list of “leukocyte genes.” See e.g. Palmer et al, Cell-type specific gene expression profiles of leukocytes in human peripheral blood, BMC Genomics. 2006 May 16;7:115. doi: 10.1186/1471-2164-7-115 (Explaining that, depending on the cell type and sample context, some genes are “preferentially expressed,” many are universally expressed in many cell types, but no single set of genes is capable of being identified as leukocyte-specific at all times; only “genes associated with the characteristic cell surface phenotype (e.g. CD8, CD3D/G, CD20), or other genes known to be associated with cell-type specific functions (such as cytotoxicity or immunoglobulin secretion)” showed any promise as “surrogates for the abundance of a particular cell subset”). In fact, “leukocyte genes” is commonly understood in many different ways, such as HLA genes, or genes associated with leukocytes generally, or genes associated with leukocytes in specific contexts such as specific diseases. See e.g. Palmer et al, Cell-type specific gene expression profiles of leukocytes in human peripheral blood, BMC Genomics. 2006 May 16;7:115. doi: 10.1186/1471-2164-7-115 (“We attempted to define the cell type specific gene expression patterns for the major constituent cells of blood, including B-cells, CD4+ T-cells, CD8+ T-cells, lymphocytes and granulocytes”). However, the specification fails to clearly link any such understanding to “leukocyte genes” here, much less clearly link “leukocyte genes” to any specific genes. Although the specification mentions the genes listed in the claims, yet these are never provided as the meaning, much less the boundary of “leukocyte genes,” rather only examples. Therefore, not only would a skilled artisan not know the fundamental meaning of “leukocyte genes” here, even more the metes and bounds are entirely unclear.
To make this point even more clear, it is unclear if Sprissler et al, Leukocyte expression profiles reveal gene sets with prognostic value for seizure-free outcome following stereotactic laser amygdalohippocampotomy, Sci Rep. 2019 Jan 31;9:1086. doi: 10.1038/s41598-018-37763-5 anticipates claims 1-10 because this reference utilizes similar phrases (“leukocyte RNA expression profiles”; “leukocyte expression profiles”; “leukocyte gene expression”; “leukocyte genes”) to describe TLE prognosis/prediction, but fails to disclose the gene listed in the specification as examples.
In claims 11-20, the gene names are inconsistent, yielding confusion. For example, the claims recite “Caspase-1 (CASP1),” then later recite “CASP,” which is a larger genus of caspase genes. It is unclear if Applicants mean this to refer back to CASP1, or they are expanding the gene list. Either way, confusion results.
The gene symbol/acronym “LYN” is also sprinkled into the claims without spelling it out, unlike the other genes, yielding confusion. For example, the claims recite “Interferon Gamma Receptor 1 (IFNGR1); however, no such recitation for LYN is provided. Thus, it is unclear if Lyn is meant to be a gene included in the list.
Claim Rejection - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Specifically, the claims are directed to the natural correlation between certain gene expression levels and temporal lobe epilepsy (TLE), without significantly more.
First, under Step 1, the claims are directed to a method to predict TLE. Thus, the claims are directed to statutory methods.
Under step 2A, prong one, the claims are clearly directed to a “method of predicting the severity of human temporal lobe epilepsy (TLE)” by detecting gene expression levels, which is a natural correlation. See MPEP § 2106.04(b).
As to step 2A, prong two, none of the claims integrate the natural correlation into a practical application. The last step of each independent claim 1 and 11, and penultimate step on claim 16 (e.g. “wherein the subject is predicted to have severe TLE if the levels of the one or more leukocyte genes are down-regulated, or the subject is predicted to have mild TLE if the levels of the one or more leukocyte genes are upregulated”) merely recite part of the natural correlation itself. Even if this was not part of the natural correlation, yet it is merely and abstract idea appended to the natural correlation. See MPEP § 2106.04(II)(A)(2). The same applies to the dependent claims that recite more specific subcategories of TLE; sample type, seizure numbers, and number of gene analyzed.
At best, claim 16 ends with “administering a treatment to the subject based on whether the subject has severe TLE or mild TLE.’ Yet, this generic treatment step is not sufficient. See MPEP § 2106.04(d)(2) (“The treatment or prophylaxis limitation must be “particular,” i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). . . . The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s).”).
As to step 2B, nor do any claims contain additional elements other than the natural correlation that yield improvements in a technology or technical field. The claims simply recite a natural correlation at a high level of generality such that the claims encompass the use of any and all routine and conventional gene expression analyses (e.g. qPCR). The claims lack any specificity whatsoever in the gene expression assay. Nor do the claims include an additional element the specifically applies the natural correlation, such as a specific predictive algorithm. Without such specificity, the claims fail to recite any additional elements that amount to a specific improvement in an assay or analysis.
Thus, the claims fail to pass muster under Section 101.
Prior Art
As to claims 11-20, the prior art fails to recite 10 of the listed genes used to predict TLE. The closest prior art discloses other genes (Sprissler et al, Leukocyte expression profiles reveal gene sets with prognostic value for seizure-free outcome following stereotactic laser amygdalohippocampotomy, Sci Rep. 2019 Jan 31;9:1086. doi: 10.1038/s41598-018-37763-5); or one to three of those claimed (CN 114839386 A; WO 2017200953; US 11000524); or large lists of maladies associated with one ore more genes listed here (WO 2004040000; WO 2020210552, myd88 and tlr1; CA 3050553, lyn; US20210353613, hmox1; WO 2021141692, tlr1 and myd88); but never 10 or more.
Conclusion
No claims are allowed.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681
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