DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This action is in response to the papers filed July 1, 2026.
Applicants election of miR-5100 (SEQ ID NO: 87) and miR-1228-5p (SEQ ID NO: 110) is reiterated for the record.
Claims 1-10, 19-24, and 26-30 are currently pending.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on July 24, 2025.
Claim Rejections - 35 USC § 101
3. 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 20-22 and 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4 Monday, January 7, 2019).
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The claims recite abstract ideas. The claims recite the following limitations:
-stratifying the subject for dementia type based on pathological findings and initiating a medical intervention in accordance with the symptoms of the subject (clm 20).
-wherein the expression level of miR-5100 is further used to evaluate therapeutic sensitivity of hippocampal atrophy or to screen for a candidate substance useful in the prevention, amelioration, or treatment of hippocampal atrophy (clm 21).
- using the expression level of miR- 5100 to evaluate or diagnose the presence or absence of amelioration of hippocampal atrophy in a subject administered a therapeutic drug selected from the group consisting of donepezil, memantine, galantamine, rivastigmine, and combinations thereof (clm 22).
The broadest reasonable interpretation of these steps is that they fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion.
For example, one may “stratify” a subject for dementia type by thinking about the pathological findings and “initiate” a medical intervention by verbally giving instructions to the subject.
One may “evaluate” therapeutic sensitivity of hippocampal atrophy by thinking about the level miR-5100 and “screen” for a candidate substance by reading a list of substances known to modulate the level of miR-5100.
Finally, one may “evaluate or diagnose” the presence or absence of amelioration o hippocampal atrophy by thinking about the level of miRNA-5100 that was detected in the sample.
The instant claims recite a law of nature. Thus the claims recite a correlation between miR-5100 and hippocampal atrophy. This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
The claims recite a step of administering to the subject, upon being classified as having hippocampal atrophy in step (c), a therapeutic drug selected from the group consisting of donepezil, memantine, galantamine, rivastigmine, and combinations thereof, for the treatment or amelioration of hippocampal atrophy or a disease accompanied thereby. While step (c) administers particular treatment for hippocampal atrophy, the administration is performed in order to gather data for further mental analysis. For example in claim 21 the administration is performed in order to gather data for evaluating the therapeutic sensitivity of hippocampal atrophy. In claim 22 the administration is performed in order to gather data for evaluating the amelioration of hippocampal atrophy. Here the administration is a necessary precursor for the judicial exceptions. It is thus extra-solution activity and does not integrate the judicial exceptions into a practical application.
In addition to the judicial exceptions the claims require measuring, by a hybridization technique, the expression level of miRNA using a probe complementary to the miRNA. This step does NOT integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity (data gathering) to the judicial exceptions.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions the claims require measuring, by a hybridization technique, the expression level of miRNA using a probe complementary to the miRNA. This step does NOT amount to significantly more because it simply appends well understood, routine, and conventional activities previously known in the art to the judicial exceptions.
The step is recited at a high level of generality. Obtaining a sample in order to perform tests is well understood, routine, and conventional activity for those in the field of diagnostics. Measuring, by a hybridization technique an expression level merely instructs a scientist to use any nucleic acid hybridization technique. The recitation that measuring uses a probe complementary to the target miRNA is general and non-specific and would encompass a large genus of probes having any level of complementarity to the target miRNA. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine, and conventional activities engaged in by scientists prior to applicants invention and at the time the application was filed.
Additionally the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available. For example the specification teaches the following:
[1243] For example, various hybridization techniques can be used for measuring the expression levels in the present invention. Examples of hybridization techniques include, but are not limited to, Northern blot (Northern hybridization), Southern blot (Southern hybridization), nucleic acid array methods such as DNA chip analysis, and in situ hybridization. PCR such as quantitative RT-PCR, nucleic acid amplification techniques such as LAMP, or next-generation sequencing can be used in combination with the hybridization technique or as an alternative thereto.
[1246] The nucleic acid array methods use, for example, an nucleic acid array in which the nucleic acid(s) for detection of hippocampal atrophy of the present invention, such as nucleic acid probe(s) (single-stranded or double-stranded probe(s)) in the kit or device of the present invention are immobilized on a solid phase (substrate). Regions of the array on which the nucleic acid probe(s) are immobilized are referred to as “probe spots”, and regions on which no nucleic acid probe(s) are immobilized are referred to as “blank spots”. An array in which a set of nucleic acids are immobilized on a solid-phase (substrate) is generally called a nucleic acid chip (a DNA chip or an RNA chip), a nucleic acid array (a DNA array or an RNA array), a microarray (a DNA microarray or an RNA microarray), or the like. In the context of the present invention, the term “nucleic acid array” includes all of such chips and arrays. The DNA or RNA array includes a DNA or RNA microarray and a DNA or RNA microarray. The nucleic acid array methods can use, for example, but not limited to, 3D-Gene® Human miRNA Oligo chip (Toray Industries, Inc., Japan) as a DNA chip.
[1253] When using quantitative RT-PCR, a commercially available kit for measurement specially designed for quantitatively measuring miRNA, such as TaqMan® MicroRNA Assays (Life Technologies Corp.), LNA®-based MicroRNA PCR (Exiqon), or Ncode® miRNA qRT-PCT kit (Invitrogen Corp.), may be used.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For the reasons set forth above the claims are not directed to patent eligible subject matter.
Response To Arguments
4. In the response the Applicants traversed the rejection under 35 USC 101. In the response the Applicants argue that claim 19 has been amended to require administration of a therapeutic agent to the subject. They note that the claims no longer encompass “performing a further diagnostic procedure”. They argue that in view of this amendment, the claims integrate any alleged judicial exception into a practical application at least because the claims require a particular treatment step following the claimed determination.
This argument has been fully considered. It is noted that claims 19, 23-24, 26, and 28-30 are no longer included in the rejection. However the rejection is maintained over claims 20-22 and 27 because these claims recite additional mental steps. While step (c) administers particular treatment for hippocampal atrophy, the administration is performed in order to gather data for further mental analysis. For example in claim 21 the administration is performed in order to gather data for evaluating the therapeutic sensitivity of hippocampal atrophy. In claim 22 the administration is performed in order to gather data for evaluating the amelioration of hippocampal atrophy. Here the administration is a necessary precursor for the judicial exceptions. It is thus extra-solution activity and does not integrate the judicial exceptions into a practical application.
5. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached on 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1634
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