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. Applicant’s election without traverse of Group I in the reply filed on November 17, 2025 is acknowledged.
Claims 1-8 and 10-11 are currently pending.
Claims 5-8 and 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 17, 2025.
Priority
3. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Korea on November 25, 2020. It is noted, however, that the foreign priority date is the effective filing date of the claimed invention IF
-the foreign application supports the claimed invention under 112(a), AND
-the applicant has perfected the right of priority by providing
-a certified copy of the priority application, and
-a translation of the priority application (if not in English).
In the instant case Applicant has submitted a certified copy of the priority application but it is not in English and the Examiner can not determine if it supports the claimed invention. The effective filing date of the Application is considered to be October 18, 2021 which is the filing date of PCT/KR2021/014469.
Claim Rejections - 35 USC § 101
4. 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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judical exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
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 instant claims recite an abstract idea.
The claims are drawn to a method for predicting the risk of developing Alzheimer’s disease (see preamble). The claim is considered to encompass “predicting”, even though there are no active process steps of “predicing” recited. The broadest reasonable interpretation of the “predicting” is that it may be accomplished by a mental process. For example, one may predict the risk of developing AD by thinking about the alleles detected at SNP rs77359862. Mental processes, which are concepts performed in the human mind (including observation, evaluation, judgment, opinions) are considered to be abstract ideas.
The claims recite a law of nature.
The claims recite a correlation between SNP rs77359862 and AD. 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.
In addition to the judical exceptions the claims require for a genetic sample obtained from a patient, confirming whether the base at position 820 is substituted (represented by NCBI refSNP ID rs77359862) in SHARPIN. 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 exception.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judical exceptions the claims require for a genetic sample obtained from a patient, confirming whether the base at position 820 is substituted (represented by NCBI refSNP ID rs77359862) in SHARPIN. This step does not amount to significantly more because it simply appends well understood, routine, and conventional activities previously known in the art, specified at a high level of generality, 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 conventinal activity for those in the field of diagnostics. Confirming whether a base at a nucleotide position is substituted merely instructs a scientist to use any genotyping technique to determine the base at a nucleotide position. When recited at this high level of generality, there is no meaningfull 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 specificaiton demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commerically available. For example the specification teaches the following:
[0035] In addition, the confirmation of the variation may be performed by identifying a genotype of the base at position 820. The confirmation of the variation is performed by sequencing, hybridization by a microarray, allele-specific PCR, dynamic allele-specific hybridization (DASH), PCR elongation assay, SSCP, PCR-RFLP analysis, a TaqMan method, an SNPlex platform (Applied Biosystems), mass spectrometry (e.g., MassARRAY system, Sequenom), mini-sequencing, a Bio-Plex system (BioRad), a CEQ and SNPstream system (Beckman), molecular inversion probe array technology (e.g., Affymetrix GeneChip), or BreadArray technology (e.g., Illumina GoldenGate and Infinium analysis), but the present invention is not limited thereto. By the above methods or other methods available to those of ordinary skill in the art, one or more alleles may be identified from polymorphic markers, including a microsatellite, an SNP or other types of polymorphic markers. Determining the base of such a polymorphic site is preferably performed using an SNP chip.
[0036] In addition, in the identifying of a genotype, genetic sequencing may be performed. The sequencing may use any method known in the art. For example, the sequencing may be performed using an automatic sequencer, or may be performed by any one or more methods of known methods such as pyrosequencing, polymerase chain reaction-restriction fragment length polymorphism (PCR-RELP), polymerase chain reaction-single strand conformation polymorphism (PCR-SSCP), polymerase chain reaction-specific sequence oligonucleotide (PCR-SSO), an allele specific oligonucleotide (ASO) hybridization combining PCR-SSO and dot hybridization, TaqMan-PCR, MALDI-TOF/MS, rolling circle amplification (RCA), high resolution melting (HRM), primer elongation, Southern blot hybridization, or dot hybridization.
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.
Claim Rejections - 35 USC § 112
5. 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.
Claims 1-4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 1-4 it is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of the claim recites a method of predicting the risk of developing Alzheimer’s disease, yet the method only requires for a genetic sample obtained from a patient, confirming whether the base at position 820 is substituted (represented by NCBI refSNP ID: rs77359862) in SHARPIN. Thus it is not clear if applicant intends to cover only a method of for a genetic sample obtained from a patient, confirming whether the base at position 820 is substituted (represented by NCBI refSNP ID: rs77359862) in SHARPIN OR if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the later, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal set forth by the preamble of the claims.
Claims 1-4 are rejected over the recitation of the phrase “the base at position 820 is substituted (represented by NCBI refSNP ID: rs77359862) in SHARPIN”. It is noted that position “820” is arbitrary without a reference sequence. The claims recite that the mutation is at position 820 but they do not refer to any particular SHARPIN sequence and different reference sequences may have different numbering schemes. This rejection could be overcome by amending the claims to recite a reference sequence for the SHARPIN gene or by only refering to the SNP as rs77359862.
Claims 1-4 are indefinite over “(represented by NCBI refSNP ID: rs77359862)”. The claims are considered indefinite because the claims contain information in parentheses. Parentheticals make the claims indefinite because it is unclear whether the information in the parentheses has the same, less, or more weight as the rest of the claim language. This rejection may be overcome by deleting the information in parentheses.
Claims 1 and 4 are rejected over the recitation of the phrase “the base at position 820 is substituted”. This recitation is indefinite because there are two possible alleles (A and G) at position 820 but it is not clear which one must be present to qualify as “substituted”. Clairification is requested.
Claim 3 is rejected over the recitation of the phrase “the amino acid at position 274 of the SHARPIN protein”. It is noted that position “274” is arbitrary without a reference sequence. The claims recite that there is an amino acid change at position 274 but they do not refer to any particular SHARPIN protein sequence and different reference sequences may have different numbering schemes.
Claim Rejections - 35 USC § 102
6. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee, Dongso (“Genome-wide assessment of MRI traits implicates SHARPIN in Alzheimer pathogenesis” Thesis, Department of Public Health, The Graduate School of Public Health Seoul National University (February 2020)).
Regarding Claims 1-4 Lee teaches that they conducted a genome wide assoication study to identify genetic variants of AD related MRI traits in Koreans (abstract). Lee teaches that patients with Alzheimers disease, mild cognitive impairment, and congitively normal subjects were genotyped using Affymetrix customized SNP chips (page 8-9). Lee teaches that SNP rs77359862 in the SHARPIN gene was correlated with two MRI traits, namely entorhinal and hippocampus. Since rs77359862 was assoicated with the hippocampus subortical volume and entorhinal region, they performed a logistic regression in order to confirm whether rs77359862 is assoicated with the AD phenotype. They considered 209 patients with AD and 985 CN subjects and the AD status was used as a response variable for logistic regression with adjustments for age and sex. They found that rs77359862 was significantly assoicated with AD status (page 15). Lee further teaches that rs77359862 results in a amino acid change of arginie to tyrptophan at position 274 of NP_112236.3 (page 19 and Fig 10). Lee further teaches that individuals had either A/A, A/G, or G/G alleles at rs77359862 (Table 6). Lee teaches that the A allele is correlated with the AD disease traits (Table 3). Thus Lee teaches a method comprising: for a genetic sample obtained from a patient, confirming whether the base at position 820 is substituted (represented by NCBI refSNP ID: rs77359862) in SHARPIN. Lee teaches the SNP is correlated (and therefore predictive) of the risk of developing AD. Lee teaches that when the base at position 820 is A, rather than G, it is predicted that the risk of developing AD is higher. Lee teaches that when the substitution of the base represented by NCBI refSNP ID: rs773 59862 occurs, the amino acid at position 274 of the SHARPIN protein changes from arginine (R) to tryptophan (W). Lee teaches the SNP is correlated (and therefore predictive) of the risk of developing AD in Koreans.
8. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Norden-Krichmar (BMC Medical Genetics 2014 15:136 pages 1-10)
As noted in MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the present situation, the process steps are able to stand alone and the preamble limitation is not accorded patentable weight. Accordingly, the claim language of “A method of predicting the risk of developing Alzheimer’s disease” merely sets forth the purpose of the process, but does not limit the scope of the claims.
Regarding Claim 1 Norden-Krichmar conducted a study to investigate genetics variants assoicated with alcohol dependence. The references teaches that DNA was extracted from blood samples, followed by genotyping using an Affymetrix Axiom Exome1A chip (abstract). It is a property of this chip that it contains probes which detect which allele is present at rs77359862.
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Thus Norden-Krichmar teaches a method comprising for a genetic sample obtained from a patient, confirming whether the base at position 820 is substituted (represented by NCBI refSNP ID: rs77359862) in SHARPIN. While Norden-Krichmar teaches the active process step of the claim, Norden-Krichmar does not teach a correlation between rs77359862 and Alzheimer’s disease. However this art rejection is set forth because it teaches a broad interpretation of the claims which does not require such a correlation because the preamble is considered to be an intended use only. This rejection could be overcome by amending the claim to recite an active process step of requiring the correlation e.g., predicting that the patient has a risk of developing AD when an A allele is detected at rs77359862.
Claim 2 recites a method wherein the base at position 820 is A, rather than G, it is predicted that the risk of developing AD is higher. It is noted that claim scope is not limited by claim language (such as wherein claues) that suggests or makes optional but does not require steps to be peformed.
Claim 3 recites a method wherein, when the substitution of the base represented by NCBI refSNP ID: rs773 59862 occurs, the amino acid at position 274 of the SHARPIN protein changes from arginine (R) to tryptophan (W). This claim merely recite properties of the SNP and does not require any additional steps to be performed.
Claim 4 recites that the method is for predicting the risk of developing AD in Koreans. This limitation modifies the preambleof claim 1 which is an intended use. Claim 4 does not require any additional steps to be performed.
9. 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 at 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 1682