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
Election/Restrictions
Applicant’s election without traverse of Group III, claim 10 and species: pTau181 in the reply filed 09/17/2025 is acknowledged.
Claims 2-7 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 09/17/2025.
Claim 10 is now under consideration in the instant Office Action.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Instant claim 10 recites limitations that are described as “optional”. This term renders the claim indefinite as it is unclear if the limitations recited after “optionally” are encompassed within the invention or not. For the purposes of examination, the instant claims will be interpreted without the optional limitations as they are not required or claimed as necessary to the invention.
Claim Rejections - 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.
Claim 10 is 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. Claim 10 is directed to a natural correlation and an abstract idea. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn to a method of diagnosing a neurological disorder status, specifically Alzheimer’s disease, comprising the steps of determining the expression level of one of several biomarkers and performing the mental step of determining the status via risk level of an individual by comparison to a reference sample. This method of diagnosis is dependent on the natural correlation that exists between the expression of several biomarker levels that takes place in a neurological disorder such as Alzheimer’s disease (AD).
Guidance effective December 16, 2014 sets out a series of steps and factors for determining subject eligibility in light of recent court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo Collaborative Services v. Prometheus Laboratories, Inc., and Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
The claims are directed to a judicial exception which comprises detecting concentration levels of biomarkers to determine the AD status of an individual. There are no physical steps in the instant claim and the method only relies on an observation of a natural correlation. The instant claims are not sufficient to qualify as a patent-eligible practical application as the claims cover every substantial practical application of the judicial exception. The claims recite steps in addition to the judicial exceptions at a high level of generality such that substantially all practical applications of the judicial exceptions are covered. Furthermore, the prior art teaches obtaining concentration levels of biomarkers using commonly known methods to determine the expression levels and determine the subject status of a neurological disorder such as AD. The prior art teaches using protein expression levels of phosphorylated 181 Tau to determine the status of a subject as taught by prior art. For example, see Mitsuhashi et al., 2018 (IDS, 9/16/2022) as discussed below. Mitushashi et al. teaches measuring phosphorylated Tau181 using immunoassays to determine the correlation to AD (see Abstract and references as discussed below). Therefore, in addition to the judicial exception, the techniques are well-understood, purely conventional or routine in the relevant field and must be taken by others to apply the judicial exception.
There are no method steps that transform the laws of nature, here, the relationship between gene expression and disease, into a practical application of those laws. The dependent claims only describe the sample or type of assay used in obtaining the correlation but are not requiring a physical step in the instantly claimed invention. The limitations are no more than a field of use or merely involve insignificant extra solution activity; e.g., data gathering, as the concentration levels of naturally occurring proteins such as amyloid beta and tau are known to be present naturally in the body of the subject and one is only observing the naturally occurring protein expression in specific patient population. They serve the ends nature originally provided and act quite independently of any effort of the patentee.
Claim 10 recites the protein expression levels that should be used to achieve the natural correlation (which is an abstract idea) in determining the status of a subject that may or may not have a neurological disorder like Alzheimer’s disease. Instant claim 10 does not require one to perform any physical steps since the natural correlation may be obtained by just looking at data that has previously been obtained by another practitioner. The comparison step of claims 10a), 10b), and 10c) are an abstract idea and do not add significantly more to the claims. Therefore, the instant invention just calls for an observation and its interpretation, as in claims 10a), 10b), and 10c) which are all mental steps and not patent eligible under § 101. The claims are not explicit as to what test to use beyond commonly used assays and do not require an apparatus of any sort. The instant claims call for comparing the naturally occurring protein expression level in a potential subject with a reference level. Even obtaining a sample from a subject or requiring an immune-detection based assay (claim 10) does not remove the instant claims from an abstract idea since the recent Alice Corp. decision indicates that requiring no more than well-understood, routine and conventional activities previously known to the industry and mere instructions to implement an abstract idea are insufficient to qualify as “significantly more” than the abstract idea itself. Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at __ (slip op., at 14) ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by'..., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)).
As discussed above, Mitsuhashi et al. teaches obtaining biological samples from a subject, determining the protein expression levels to reach a diagnosis. Therefore, in addition to the judicial exception, the claimed techniques are well-understood, purely conventional or routine in the relevant field and must be taken by others to apply the judicial exception. The limitations are no more than a field of use or merely involve insignificant extra solution activity; e.g., data gathering, as the genes are known to be present naturally in the body of the subject and will undergo natural processes in response to a stimulant/agent or disease. They serve the ends nature originally provided and act quite independently of any effort of the patentee. See Myriad, 133 S. Ct. at 2117.
Therefore, these claims do not contain patent eligible material.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 10 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mitsuhashi et al. (WO 2018/218090 A1, in IDS filed 09/16/2022).
Mitsuhashi et al. teaches methods, compositions, and kits for detecting and quantifying biomarkers for the diagnosis of neurological disorders such as Alzheimer's disease (AD), see Abstract.
These biomarkers include neuron specific proteins or cytosolic proteins or membrane specific proteins such as tau, phosphorylated tau (T181), Aβ, Aβ-42, NEFL, neurogranin, synaptophysin, cathepsin-D (CTSD), TREM2, REST, CD274, synaptopodin, see abstract, claims 1, 6, 7, 13, 14 & 20-22, paragraphs 0011, 0023, 0030, 0033. Mitsuhashi et al. teach how said assay methods deploy capture agents such as antibodies that selectively bind to the biomarkers for measuring their expression levels, see claims 27-30, 33, 34 & 39 and paragraph 0034, and how the risk assessment/diagnosis of AD is carried out by comparing expression levels of biomarkers in subjects to the control levels, see claims 40, 42, 45, 49-56 & 61-63, paragraphs 0007, 0037, 0084, 00105, 00127, 00138, 00144, and Examples 5 & 6. Further, estimation of risk score to determine the risk of disease has no particular advantage as a difference in expression levels of biomarkers between subjects and controls per se itself is indicative of risk of disease condition.
Therefore, claim 10 is anticipated by Mitsuhashi et al.
Conclusion
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675