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 5/20/2024 are under consideration.
Priority
This application claim foreign priority to TAIWAN 112125120 (filed 7/5/2023). A certified copy of the foreign priority document has been received; however, no English translation has been provided.
Drawings
High resolution copies of the drawings may be accessed via PAIR/Patent Center Retrieval using the Supplemental Content tab.
Specification
The disclosure is objected to because of the following informalities: the specification uses the term “SEQ ID NO.” rather than “SEQ ID NO:”.
Appropriate correction is required.
Claim Objections
Claims 1, 5, 9 and 10 are objected to because of the following informalities: the claims use the term “SEQ ID NO.” rather than “SEQ ID NO:”. Appropriate correction is required.
Claim Interpretation
Terms in parentheticals are interpreted as being abbreviations for the preceding terms.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
The claim(s) recite(s):
“judging that the inspection subject has the risk of metastatic colorectal cancer when the expression level of the biomarker is a multiple of a standard expression level” (claim 1);
“when the expression level of the biomarker is a multiple of a standard expression level” (claim 1);
“judging the prognostic level of the inspection subject according to the expression level of the biomarker” (claim 5); and
“the expression level of the biomarker and the prognostic level are positively correlated” (claim 5).
The above “judging” steps broadly encompass abstract ideas as they can be performed in a purely mental manner. The claims involve the analysis and comparison of a minimal amount of data, i.e., a single expression level for a single miRNA biomarker.
The above statement about the “expression level” in claim 1 sets forth a natural correlation between an “expression level” and a risk of metastatic colorectal cancer.
The above statement regarding “the expression level” in claim 5 sets forth a natural correlation between an “expression level” and a prognostic level.
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 additional steps are data gathering steps.
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 PCR, which is a routine and conventional assay.
Claims 9 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims broadly encompass nucleic acid fragments having SEQ ID NO: 1. These nucleic acid fragments encompass naturally occurring miRNA sequences and thus broadly encompass natural products.
The claim also encompasses “a biomarker”, which broadly encompasses information, which is an intangible element. The intangible information encompassed by a “biomarker” is an abstract idea.
Thus, the claim broadly encompasses a judicial exception in the form of a natural product and an abstract idea.
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 9 and 10 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 9-10, the claims are directed to a “biomarker” being “EV-miR-320c with the sequence of SED ID NO.1”. It is unclear what structural features constitute the “biomarker”. Is the biomarker simply a knowledge of EV-miR-320c? Is the “biomarker” a physical nucleic acid molecule? Because it is unclear what constitutes the biomarker, i.e. what the structure of the biomarker panel is, it is unclear what structure is required by the product claims.
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) 1-2, 4-7 and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsumura (British Journal of Cancer. 2015. 113:275-281).
Regarding claim 1, Matsumura teaches “separating a plurality of extracellular vesicles from a biological sample” by isolating exomes from serum (p. 276, Isolation of exosomes from serum).
Matsumura teaches using a microarray as “an inspection method to inspect the expression level of a biomarker in the extracellular vesicles” (p. 276, Extraction of total RNA and miRNA and miRNA microarray analysis).
Matsumura teaches judging a risk of liver metastasis of colorectal cancer is present when expression level of hsa-miR-320c has a fold change of 6.18 of a “standard expression level” (Table 1).
SEQ ID NO:1 is the known sequence of naturally occurring mature has-miR-320c.
Regarding claim 2, as noted above, Matsumura teaches the biological sample is serum.
Regarding claim 4, Matsumura teaches the “standard expression level” is from healthy samples (p. 278).
Regarding claim 5, Matsumura teaches “separating a plurality of extracellular vesicles from a biological sample” by isolating exomes from serum (p. 276, Isolation of exosomes from serum).
Matsumura teaches using a microarray as “an inspection method to inspect the expression level of a biomarker in the extracellular vesicles” (p. 276, Extraction of total RNA and miRNA and miRNA microarray analysis).
Matsumura teaches judging a prognostic level of liver metastasis of colorectal cancer is present when the expression level of hsa-miR-320c has a fold change of 6.18 of a “standard expression level” (Table 1).
SEQ ID NO:1 is the known sequence of naturally occurring mature has-miR-320c.
Regarding claim 6, as noted above, Matsumura teaches the biological sample is serum.
Regarding claim 7, Matsumura teaches the patients were being treated with surgery for the resection of primary tumors (p. 276, Patients and sample collection).
Regarding claims 9 and 10, Matsumura teaches hsa-miR-320c as a “biomarker” with at least a two-fold change in expression within exosomes (Table 1).
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (Cellular Oncology. 2022. 45:621-638; cited on the 11/1/2024 IDS).
Regarding claim 1-10, Yang clearly teaches the elements of claims 1-10 in: Figs. 2, 3, 4 and 6; Table 3; and 2 Materials and methods.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsumura (British Journal of Cancer. 2015. 113:275-281).
Regarding claim 3, Matsumura teaches “separating a plurality of extracellular vesicles from a biological sample” by isolating exomes from serum (p. 276, Isolation of exosomes from serum).
Matsumura teaches using a microarray as “an inspection method to inspect the expression level of a biomarker in the extracellular vesicles” (p. 276, Extraction of total RNA and miRNA and miRNA microarray analysis).
Matsumura teaches judging a risk of liver metastasis of colorectal cancer is present when expression level of hsa-miR-320c has a fold change of 6.18 of a “standard expression level” (Table 1).
SEQ ID NO:1 is the known sequence of naturally occurring mature has-miR-320c.
Regarding claim 8, Matsumura teaches “separating a plurality of extracellular vesicles from a biological sample” by isolating exomes from serum (p. 276, Isolation of exosomes from serum).
Matsumura teaches using a microarray as “an inspection method to inspect the expression level of a biomarker in the extracellular vesicles” (p. 276, Extraction of total RNA and miRNA and miRNA microarray analysis).
Matsumura teaches judging a prognostic level of liver metastasis of colorectal cancer is present when the expression level of hsa-miR-320c has a fold change of 6.18 of a “standard expression level” (Table 1).
SEQ ID NO:1 is the known sequence of naturally occurring mature has-miR-320c.
While Matsumura teaches the above methods, Matsumura does not specifically teach the use of qRT-PCR to inspect the expression level of miR-320c.
However, Matsumura teaches the use of qRT-PCR for assessing miRNA levels was known (p. 277, qRT-PCR analysis of miRNAs).
It would have been prima facie obvious to the ordinary artisan at the time of filing to have modified the method of Matsumura and analyze the expression level of hsa-miR-320c and the other exosomal miRNAs of Table 1 in order to confirm the microarray array data.
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
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