DETAILED ACTION
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 .
The claims dated 5/8/2024 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 12-16, in the reply filed on 7/20/2026 is acknowledged.
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 7/20/2026.
Priority
The present application is a 371 national stage entry of PCT/KR2022/006918 (filed 5/13/2022) and claims benefit of REPUBLIC OF KOREA 10-2021-0062992 (filed 5/14/2021).
It is noted an English translation of the foreign priority document has not been received.
Drawings
High resolution copies of the drawings may be accessed via PAIR/Patent Center Retrieval using the Supplemental Content tab.
Specification
The use of terms that are trade names or marks used in commerce has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 12 is objected to because of the following informalities: the claim recites “at least one selected”. It appears that a term is missing that describes the “at least one” of what is being measured, e.g., “at least one miRNA selected” or “at least one biomarker selected”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: the claim recites “real-time. Polymerase chain reaction (Real-time PCR)”, which includes an extraneous period. Appropriate correction is required.
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 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
The claim is drawn to a method, one of the four statutory categories.
The claim recites:
“determining that the progression of the neurodegenerative diseases is rapid”; and
“when at least one selected from the group consisting of miRNA- 214 and miRNA-34c exhibits a high expression level”.
The step of “determining” is an abstract idea which can be performed in a purely mental manner. The claim encompasses making a “determination” based on the consideration of a single piece of data, i.e., the expression level of miRNA-214 or miRNA-34c. This amount of data may be considered in the human mind and/or with the aid of pen and paper. MPEP 2106.04(a)(2)(III). The step represents an observation and evaluation of information to reach a judgment or conclusion.
The statement regarding how the determination is made based on the expression level of miRNA-214 or miRNA-34c also represents a judicial exception. Where the evaluation of data to reach a conclusion is based on a correlation between miRNA levels and the presence of a particular pathology, such an association is an accepted part of how a biological organism functions (i.e.: miRNA/disease progression), and as such this element of the claims is a natural phenomenon (e.g., MPEP 2106.04(b)(I)).
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions. The steps are mere data gathering steps. See MPEP 2106.05(g).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass the use of well-known assays, such as PCR, microarrays and northern blotting, used in a conventional manner as described in paragraph 64 of the instant specification.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
The specification, while being enabling for embodiments in which the biological sample is plasma, does not reasonably provide enablement for all types of biological samples and all types of neurodegenerative diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The claim broadly encompasses measuring the expression level of miR-34c or miR-214 in any biological sample. The instant specific only analyzed the slow versus rapid progression using miR-34c or miR-214 levels found in plasma. Liang (BMC Genomics. 2007. 8:166) demonstrates that miRNA levels vary between different types of samples. Thus, it is unpredictable that miRNA levels in biological samples other than plasma may be used to determine rapid progression that occurs when miR-34c or miR-214 levels are “high”.
The claim broadly encompasses neurodegenerative diseases such as Parkinson's disease, dementia, Alzheimer's disease, Frontotemporal dementia, Huntington's disease, stroke, cerebral infarction, Pick's disease, head trauma, spinal cord injury, cerebral arteriosclerosis, ALS, multiple sclerosis, geriatric depression, or Creutzfeldt-Jakob disease (para. 48 of the instant specification). Each of these diseases have different etiologies and potentially are derived from or impact different tissues or cell types. As noted above, Liang demonstrates that miRNA levels vary between the source of the miRNAs. Thus, it is unpredictable that the miRNA levels observed in ALS patients may be extrapolated to determine rapid progression of all types of neurodegenerative disease, including head trauma, spinal cord injury, cerebral arteriosclerosis, multiple sclerosis, geriatric depression, or Creutzfeldt-Jakob disease.
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.
Claims 13-15 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 claim 13, the claim recites “exhibits a high expression level”. The term “high” is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what expression level is sufficient to be considered “high”.
Regarding claims 14 and 15, the claim recites “the miRNA…is represented by the base sequence of SEQ ID NO:…”. The use of the term “represented” renders the claim indefinite. It is unclear if the miRNA “comprises” the sequence of the recited SEQ ID NOs, “consists of” the sequence of the recited SEQ ID NOs or encompasses portions of the sequence of the recited SEQ ID NOs.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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(s) 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noh (“Defective phagocytic function of induced microglia-like cells is correlated with rapid progression of sporadic ALS.” May 23, 2020).
Regarding claims 12 and 16, Noh teaches measuring the expression level of miR-34c-3p and miR-214-3p (Fig. 7) using quantitative real-time PCR (p. 10/42, Plasma miRNA analysis).
Regarding claim 13, Noh teaches an association between increasing expression levels of miR-34c-3p or miR-214-3p and increasing delta-FS and determining slow or rapid progression based on the relative “higher” levels of miR-34c-3p miR-214-3p (Fig. 7).
Regarding claims 14 and 15, Noh teaches the sequences of miRNA-214 and miRNA-34c in Fig. 7, which are broadly encompassed as being “represented by” SEQ ID NOs: 1 and 2 of the present application.
Claim(s) 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhatnagar (Frontiers in Molecular Neuroscience. 2014. 7: article 2, 11 pages).
Regarding claims 12 and 16, Bhatnagar teaches measuring the expression levels of miR-34c using Taqman MicroRNA Real Time qPCR (p. 2).
Regarding claim 13, Bhatnagar teaches determining progression of Alzheimer’s disease between moderate and mild forms that occurs when levels of miR-34c are “high” (Fig. 5).
Regarding claim 14, the claim does not specify the level of miRNA-214 is measured, and broadly encompassing measuring the expression of miRNA-34c or miRNA-214 represented by the base sequence of SEQ ID NO: 1. The embodiments of claim 14 encompassing the measuring of miRNA-34c are anticipated.
Regarding claim 15, the sequence of miRNA-34c is
agucuaguuacuAGGCAGUGUAGUUAGCUGAUUGCuaauaguaccAAUCACUAACCACACGGCCAGGuaaaaagauu
as evidenced by miRBase. The sequence includes the sequence represented by present SEQ ID NO: 2, which is underlined in the above sequence of miRNA-34c.
Claim(s) 12 and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Andrade (Journal of the Neurological Sciences. 2016. 368: 19-24).
Regarding claims 12 and 16, de Andrade teaches measuring the expression levels of miR-214 using microarray technology (p. 20, 2.4.2. Gene Chip miRNAarray analysis and p. 21, 2.4.3. Choice of candidate miRNAs for plasma analyses).
Regarding claim 14, the sequence of miRNA-214 is
ggccuggcuggacagaguugucaugugucUGCCUGUCUACACUUGCUGUGCagaacauccgcucaccuguACAGCAGGCACAGACAGGCAGUcacaugacaacccagccu
as evidenced by miRBase. The sequence includes the sequence represented by present SEQ ID NO: 1, which is underlined in the above sequence of miRNA-214.
Regarding claim 15, the claim does not specify the level of miRNA-34c is measured, and broadly encompassing measuring the expression of miRNA-214 or miRNA-34c represented by the base sequence of SEQ ID NO: 2. The embodiments of claim 15 encompassing the measuring of miRNA-214 are anticipated.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
