Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reopening of Prosecution After Pre-Appeal Brief Conference
In view of the pre-Appeal brief conference requested om 10/2/2025 and the pre-brief appeal conference decision on 10/24/2025, PROSECUTION IS HEREBY REOPENED. New grounds for rejection set forth below.
Election/Restrictions
Claims 23-24 and 36-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/27/2015.
Claims 80-85 and 88-93 are under consideration in the instant Office Action.
Withdrawn Rejections
The rejection of claims 80-85 and 88-93 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over by Alkon et al., US2010/0021913 (11/10/2015 PTO-892) in view of Mueller et al., 2005 (6/26/2019 PTO-892) and Chen et al., 2010 (4/9/2021 PTO-892) is withdrawn upon further consideration.
New Rejections
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.
Claims 80-85 and 88-93 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
The claims are drawn to a method for detecting gene expression levels in a human subject diagnosed with Alzheimer's disease. The specification states the method as a method for diagnosing Alzheimer’s disease but the instant claims already have identified the patients as Alzheimer’s patients, therefore it is unclear what is the purpose or utility of this claimed method. For example, the specification teaches that “the diagnostic method as disclosed herein comprises detecting differential expression in the control sample and the cell sample of at least five genes listed in Table 1 and/or Table 2 (see [040]). The specification only mentions this utility as a diagnostic method so how can you diagnose an already diagnosed patient population. In other words, there is no readily apparent use for the method as claimed.
A specific and substantial utility is one that is particular to the subject matter claimed and that identifies a “real world” use for the claimed invention. MPEP § 2106 (II)(A), for example, states:
The claimed invention as a whole must be useful and accomplish a practical application. That is, it must produce a “useful, concrete and tangible result.” State Street Bank & Trust Co. v. Signature Financial Group Inc., 149 F.3d 1368, 1373-74, 47 USPQ2d 1596, 1601-02 (Fed. Cir. 1998). The purpose of this requirement is to limit patent protection to inventions that possess a certain level of “real world” value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research (Brenner v. Manson, 383 U.S. 519, 528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).
In the instant case, there is no clear or possible application for the method as claimed. There are possible utilities for the individual components of the method but it is unclear what is the utility of the instant method as claimed which have this specific steps in the method.
The claimed invention also lacks a well-established utility. A well-established utility is a specific, substantial, and credible utility that is well known, immediately apparent, or implied by the specification’s disclosure of the properties of a material.
Accordingly, the method of claims 80-85 and 88-93 lack a specific and substantial asserted utility and a well-established utility, and does not fulfill the requirements under 35 U.S.C. 101.
Claims 80-85 and 88-93 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. Claims 80-85 and 88-93 are determined to be directed to a law of nature/natural principle. 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 Alzheimer’s disease (AD) comprising the steps of contacting a population of test cells, fibroblast or lymphocyte, from a subjects suspected of having AD with a stimulus that includes protein kinase C (PKC) activator and Ab oligomer and detecting changes in expression of one or more genes, wherein a change in test cells as compared to control cells indicates AD. This method of diagnosis is dependent on the natural correlation that exists between the increase/decrease of gene expression that takes place in Alzheimer's disease. The claims implicitly requires the natural correlation that exists between the increase/decrease of gene expression that takes place in Alzheimer's disease.
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 a gene expression response to a stimulus to diagnose Alzheimer’s disease. The active steps of instant claims are contacting a cell with a stimulus and detecting a response through a comparison to a control. These steps 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, using primary fibroblast cells or lymphocytes for measuring gene expression in response to a stimulus to obtain a diagnosis is known in the prior art: for example, Alkon et al., US2010/0021913 (11/10/2015 PTO-892). Alkon teaches a method of diagnosing Alzheimer’s disease by contacting a cell sample from a subject with Alzheimer's disease (test cell) with an agent and detecting the gene expression changes in the cell (see paragraphs 14, 35-37 and claim 1). 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 method step of contacting cells with a stimulus is merely a step performed to bring about or arrive at the correlation, and nonetheless, this method step was well known in the art prior to filing: see Chirila et al., US2011/0136144 (11/10/2015, PTO-892). Chirila teaches using a method to diagnose Alzheimer's disease by culturing fibroblast cells obtained from a peripheral skin biopsy of an AD patient (see paragraphs 5-11, 23 118). Kalman et al., 2005 (4/25/2018, PTO-892) also shows that microarray assays of lymphocytes from AD patients have different gene expression from controls. The limitations are no more than a field of use or merely involve insignificant extrasolution 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.
Dependent claims when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to natural phenomena/natural correlation, as detailed below: Dependent claims recite the gene expression is increased or decreased: the genes that are part of the natural correlation; that cells are fibroblasts; what stimulus is being applied to the cells; and what criteria should be used to achieve the correlation of diagnosis in relation to a neurodegenerative disease such as Alzheimer’s disease. These limitations are either towards the judicial exception, the genes needed to establish the correlation to AD, or describing the required factors to perform the method that is routine and conventional in the art. As already stated above, the methods that are found in the method of diagnosis are disclosed throughout the prior art and are routine and conventional. The instant claim limitations or any combination of these limitations do not encompass anything that is considered “significantly more”.
Therefore, these claims do not contain patent eligible material.
Conclusion
No claims are allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675